78. 下垂体前葉機能低下症 Hypopituitarism Clinical trials / Disease details
臨床試験数 : 492 / 薬物数 : 341 - (DrugBank : 47) / 標的遺伝子数 : 45 - 標的パスウェイ数 : 100
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JPRN-jRCT2031200340 | 14/06/2021 | 02/02/2021 | A trial to compare lonapegsomatropin (TransCon hGH) administered once a week and standard daily hGH replacement therapy over 52 weeks in Japanese prepubertal hGH-treatment naive children with growth hormone deficiency (GHD) | A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the efficacy, safety, and tolerability of lonapegsomatropin (TransCon hGH) administered once a week versus standard daily hGH replacement therapy over 52 weeks in Japanese prepubertal hGH-treatment naive children with growth hormone deficiency(GHD) - riGHt | Pediatric growth hormon deficiency | Lonapegsomatropin will be administered as once weekly subcutaneous (SC) injections of 0.24 mg hGH/kg/week using GH Auto-Injector. Genotropin will be administered as daily SC injections in a standard dose of 0.24 mg hGH/kg/week. The total weekly dose will be equally split into 7 daily doses of 0.034 mg hGH/kg/day. A commercially approved injection device will be used for administration of the drug. Lonapegsomatropin will be administered as once weekly subcutaneous (SC) injections of 0.24 mg hGH/kg/week using GH Auto-Injector. Lonapegsomatropin will be administered as once weekly subcutaneous (SC) injections of 0.24 mg hGH/kg/week using GH Auto-Injector. | Beckert Michael | NULL | Recruiting | >= 3age old | <= 16age old | Both | 50 | Phase 3 | Japan |
| 2 | NCT04326374 (ClinicalTrials.gov) | December 30, 2019 | 26/3/2020 | Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Chinese Pediatric Growth Hormone Deficiency | The Efficacy, Safety and Tolerability of TransCon hGH Administered Weekly Versus Daily hGH in Prepubertal Children With Growth Hormone Deficiency: a Randomized, Open-lable, Active-controlled, Parallel-group Study in China | Growth Hormone Deficiency;Endocrine System Diseases;Hormones;Pituitary Diseases;Pituitary Disease, Anterior | Drug: TransCon hGH;Drug: daily hGH | Visen Pharmaceuticals (Shanghai) Co., Ltd. | Ascendis Pharma A/S | Recruiting | 3 Years | 17 Years | All | 150 | Phase 3 | China |
| 3 | EUCTR2017-003410-20-RO (EUCTR) | 17/01/2019 | 13/05/2022 | A long-term extension trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in prepubertal children | enliGHten: A Multicenter, Phase 3, Long-term, Open-label Trial Investigating Safety and Efficacy of TransCon hGH Administered Once-Weekly in Children with Growth Hormone Deficiency (GHD) Who Have Completed a Prior TransCon hGH Clinical Trial - enliGHten | Growth hormone deficiency (GHD) in prepubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: TransCon hGH (ACP-011) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH Product Name: TransCon hGH (ACP-011) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | United States;Belarus;Greece;Ukraine;Turkey;Russian Federation;Italy;Armenia;Canada;Poland;Romania;Australia;Bulgaria;Georgia;New Zealand | ||
| 4 | EUCTR2017-003410-20-IT (EUCTR) | 30/10/2018 | 11/10/2018 | A long-term extension trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in children | enliGHten: A Multicenter, Phase 3, Long-term, Open-label Trial Investigating Safety and Efficacy of TransCon hGH Administered Once-Weekly in Children with Growth Hormone Deficiency (GHD) Who Have Completed a Prior TransCon hGH Clinical Trial - enliGHten | Growth hormone deficiency (GHD) in prepubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: TransCon hGH (ACP-011) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH Product Name: TransCon hGH (ACP-011) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Belarus;Greece;Ukraine;Turkey;Russian Federation;Italy;Armenia;Canada;Poland;Romania;Australia;Bulgaria;Georgia;Germany | ||
| 5 | EUCTR2017-003410-20-PL (EUCTR) | 23/10/2018 | 08/11/2018 | A long-term extension trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in children | enliGHten: A Multicenter, Phase 3, Long-term, Open-label Trial Investigating Safety and Efficacy of TransCon hGH Administered Once-Weekly in Children with Growth Hormone Deficiency (GHD) Who Have Completed a Prior TransCon hGH Clinical Trial - enliGHten | Growth hormone deficiency (GHD) in prepubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: TransCon hGH (ACP-011) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH Product Name: TransCon hGH (ACP-011) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Belarus;United States;Greece;Ukraine;Turkey;Russian Federation;Italy;Armenia;Canada;Poland;Romania;Australia;Georgia;Bulgaria;Germany | ||
| 6 | EUCTR2017-003410-20-GR (EUCTR) | 04/06/2018 | 19/04/2018 | A long-term extension trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in prepubertal children | enliGHten: A Multicenter, Phase 3, Long-term, Open-label Trial Investigating Safety and Efficacy of TransCon hGH Administered Once-Weekly in Children with Growth Hormone Deficiency (GHD) Who Have Completed a Prior TransCon hGH Clinical Trial - enliGHten | Growth hormone deficiency (GHD) in prepubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: TransCon hGH (ACP-011) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH Product Name: TransCon hGH (ACP-011) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Belarus;Greece;Ukraine;Turkey;Russian Federation;Italy;Armenia;Canada;Poland;Romania;Australia;Bulgaria;Georgia;New Zealand | ||
| 7 | EUCTR2017-003410-20-BG (EUCTR) | 20/04/2018 | 09/01/2018 | A long-term extension trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in prepubertal children | enliGHten: A Multicenter, Phase 3, Long-term, Open-label Trial Investigating Safety and Efficacy of TransCon hGH Administered Once-Weekly in Children with Growth HormoneDeficiency (GHD) Who Have Completed a Prior TransCon hGH Clinical Trial - enliGHten | Growth hormone deficiency (GHD) in prepubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: TransCon hGH (ACP-011) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH Product Name: TransCon hGH (ACP-011) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH | Ascendis Pharma Endocrinology Division A/S | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Belarus;Greece;Ukraine;Turkey;Russian Federation;Italy;Armenia;Canada;Poland;Romania;Australia;Bulgaria;Georgia;New Zealand | ||
| 8 | EUCTR2016-001145-11-DE (EUCTR) | 12/02/2018 | 14/12/2016 | A trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in prepubertal children | A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the safety, tolerability, and efficacy of TransCon hGH administered once a week versus standard daily hGH replacement therapy over 52 weeks in prepubertal children with growth hormone deficiency (GHD) | Growth hormone deficiency (GHD) in prepubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: TransCon hGH (ACP-011) - 12.1mg INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH, Transiently PEGylated hGH prodrug Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Product Name: TransCon hGH (ACP-011) - 24.2mg | Ascendis Pharma Endocrinology Division A/S | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Lebanon;Russian Federation;Chile;Azerbaijan;Italy;France;Jordan;Australia;South Africa;Lithuania;Turkey;United Kingdom;Egypt;Armenia;Canada;Poland;Brazil;Romania;Kazakhstan;Bulgaria;Georgia;Germany;New Zealand;Sweden;Belarus;United States;Greece;Kyrgyzstan;Spain;Ukraine | ||
| 9 | NCT03344458 (ClinicalTrials.gov) | December 19, 2017 | 14/11/2017 | A Long-Term Trial Investigating Safety and Efficacy of TransCon hGH in Children With Growth Hormone Deficiency Who Have Completed a Prior TransCon hGH Clinical Trial | enliGHten: A Multicenter, Phase 3, Long-Term, Open-Label Trial Investigating Safety and Efficacy of TransCon hGH Administered Once-Weekly in Children With Growth Hormone Deficiency (GHD) Who Have Completed a Prior TransCon hGH Clinical Trial | Growth Hormone Deficiency, Pediatric;Endocrine System Diseases;Hormone Deficiency;Pituitary Diseases | Drug: TransCon hGH | Ascendis Pharma A/S | NULL | Active, not recruiting | 1 Year | 18 Years | All | 298 | Phase 3 | United States;Armenia;Australia;Belarus;Bulgaria;Georgia;Greece;New Zealand;Poland;Russian Federation;Ukraine |
| 10 | NCT03305016 (ClinicalTrials.gov) | November 13, 2017 | 4/10/2017 | A Safety, Tolerability and Efficacy Study of TransCon hGH in Children With Growth Hormone Deficiency | fliGHt: A Multicenter, Phase 3, Open-Label, 26-Week Trial Investigating the Safety, Tolerability and Efficacy of TransCon hGH Administered Once Weekly in Children With GHD | Growth Hormone Deficiency, Pediatric;Endocrine System Diseases;Hormone Deficiency;Pituitary Diseases | Drug: TransCon hGH | Ascendis Pharma Endocrinology Division A/S | NULL | Completed | 6 Months | 17 Years | All | 146 | Phase 3 | United States;Australia;Canada;New Zealand |
| 11 | EUCTR2016-001145-11-IT (EUCTR) | 07/04/2017 | 10/01/2017 | A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the safety, tolerability, and efficacy of TransCon hGH administered once a week versus standard daily hGH replacement therapy over 52 weeks in prepubertal children with growth hormone deficiency (GHD) | A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the safety, tolerability, and efficacy of TransCon hGH administered once a week versus standard daily hGH replacement therapy over 52 weeks in prepubertal children with growth hormone deficiency (GHD) | Growth hormone deficiency (GHD) in prepubertal children MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: TransCon hGH CT-301 (ACP-011) - 12,1mg INN or Proposed INN: TransCon hGH (ACP-011) Other descriptive name: Transiently PEGylated hGH prodrug Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Product Name: Sterile Water for Injection | Ascendis Pharma Endocrinology Division A/S | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Belarus;Greece;Kyrgyzstan;Spain;Ukraine;Lebanon;Chile;Russian Federation;Azerbaijan;Italy;France;Jordan;Australia;South Africa;Turkey;Lithuania;United Kingdom;Egypt;Armenia;Canada;Brazil;Poland;Romania;Kazakhstan;Georgia;Bulgaria;Germany;New Zealand;Sweden | ||
| 12 | EUCTR2016-001145-11-PL (EUCTR) | 31/03/2017 | 17/01/2017 | A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the safety, tolerability, and efficacy of TransCon hGH administered once a week versus standard daily hGH replacement therapy over 52 weeks in prepubertal children with growth hormone deficiency (GHD) | A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the safety, tolerability, and efficacy of TransCon hGH administered once a week versus standard daily hGH replacement therapy over 52 weeks in prepubertal children with growth hormone deficiency (GHD) | Growth hormone deficiency (GHD) in prepubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: TransCon hGH (ACP-011) - 12.1mg INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH, Transiently PEGylated hGH prodrug Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Product Name: TransCon hGH (ACP-011) - 24.2mg | Ascendis Pharma Endocrinology Division A/S | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Belarus;Greece;Kyrgyzstan;Spain;Ukraine;Lebanon;Chile;Russian Federation;Azerbaijan;Italy;France;Jordan;Australia;South Africa;Turkey;Lithuania;United Kingdom;Egypt;Armenia;Canada;Brazil;Poland;Romania;Kazakhstan;Georgia;Bulgaria;Germany;New Zealand;Sweden | ||
| 13 | EUCTR2016-001145-11-GR (EUCTR) | 28/03/2017 | 02/02/2017 | A trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in prepubertal children | A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the safety, tolerability, and efficacy of TransCon hGH administered once a week versus standard daily hGH replacement therapy over 52 weeks in prepubertal children with growth hormone deficiency (GHD) | Growth hormone deficiency (GHD) in prepubertal children MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: TransCon hGH (ACP-011) - 12,1mg INN or Proposed INN: TransCon hGH (ACP-011) Other descriptive name: Transiently PEGylated hGH prodrug Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin | Ascendis Pharma Endocrinology Division A/S | NULL | Not Recruiting | Female: yes Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Belarus;United States;Greece;Kyrgyzstan;Spain;Ukraine;Lebanon;Russian Federation;Chile;Azerbaijan;Italy;France;Jordan;Australia;South Africa;Lithuania;Turkey;United Kingdom;Egypt;Armenia;Canada;Poland;Brazil;Romania;Kazakhstan;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 14 | NCT02781727 (ClinicalTrials.gov) | December 13, 2016 | 19/5/2016 | A Phase 3 Trial of the Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD) | A Multicenter, Phase 3, Randomized, Open-label, Active-controlled, Parallel-group Trial Investigating the Safety, Tolerability, and Efficacy of TransCon hGH Administered Once a Week Versus Standard Daily hGH Replacement Therapy Over 52 Weeks in Prepubertal Children With Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency, Pediatric;hGH (Human Growth Hormone);Endocrine System Diseases;Hormones;Pituitary Diseases | Drug: Once weekly subcutaneous injection of TransCon hGH;Drug: Once daily subcutaneous injection of Genotropin | Ascendis Pharma Endocrinology Division A/S | NULL | Completed | 3 Years | 12 Years | All | 161 | Phase 3 | United States;Armenia;Australia;Belarus;Bulgaria;Georgia;Greece;Italy;New Zealand;Poland;Romania;Russian Federation;Turkey;Ukraine |
| 15 | NCT01247675 (ClinicalTrials.gov) | November 2010 | 23/11/2010 | A Safety, Pharmacokinetic and Pharmacodynamic Study of ACP-001 (TransCon hGH) in Adults With Growth Hormone Deficiency | A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients With Growth Hormone Deficiency | Adult Growth Hormone Deficiency | Drug: ACP-001 (TransCon hGH);Drug: Omnitrope | Ascendis Pharma A/S | NULL | Completed | 20 Years | 70 Years | All | 37 | Phase 2 | Denmark;Germany;Italy;Sweden |
| 16 | EUCTR2016-001145-11-BG (EUCTR) | 11/01/2017 | A trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in prepubertal children | A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the safety, tolerability, and efficacy of TransCon hGH administered once a week versus standard daily hGH replacement therapy over 52 weeks in prepubertal children with growth hormone deficiency (GHD) | Growth hormone deficiency (GHD) in prepubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: TransCon hGH (ACP-011) - 12.1mg INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH, Transiently PEGylated hGH prodrug Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Product Name: TransCon hGH (ACP-011) - 24.2mg INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH, Transiently PEGylated hGH prodrug | Ascendis Pharma Endocrinology Division A/S | NULL | Not Recruiting | Female: yes Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Belarus;United States;Greece;Kyrgyzstan;Spain;Ukraine;Lebanon;Russian Federation;Chile;Azerbaijan;Italy;France;Jordan;Australia;South Africa;Lithuania;Turkey;United Kingdom;Egypt;Armenia;Canada;Poland;Brazil;Romania;Kazakhstan;Bulgaria;Georgia;Germany;New Zealand;Sweden |