Gb002 (DrugBank: -)
1 disease告示番号 | 疾患名(ページ内リンク) | 臨床試験数 |
---|---|---|
86 | 肺動脈性肺高血圧症 | 5 |
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 |
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1 | NCT04456998 (ClinicalTrials.gov) | December 2020 | 30/6/2020 | GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH) | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | Pulmonary Artery Hypertension | Drug: GB002;Drug: Placebo;Device: Generic Dry Powder Inhaler | GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. | NULL | Recruiting | 18 Years | 80 Years | All | 80 | Phase 2 | United States |
2 | EUCTR2019-002669-37-GB (EUCTR) | 08/10/2020 | 11/05/2020 | Clinical Study of Inhaled GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: GB002 Capsules Product Code: GB002 INN or Proposed INN: Seralutinib Other descriptive name: (S)-3-((3-(1-((6-(3,4-DIMETHOXYPHENYL)PRYAZIN-2-YL)AMINO)ETHYL)PHENYL)CARBAMOYL)-5-METHYLPRIDIN-1-IUM | GB002, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | United States;Serbia;France;Austria;Australia;Israel;Germany;United Kingdom;Canada;Belgium;Singapore | ||
3 | EUCTR2019-002669-37-FR (EUCTR) | 01/10/2020 | 15/07/2020 | Clinical Study of Inhaled GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: GB002 Capsules Product Code: GB002 INN or Proposed INN: Seralutinib Other descriptive name: (S)-3-((3-(1-((6-(3,4-DIMETHOXYPHENYL)PRYAZIN-2-YL)AMINO)ETHYL)PHENYL)CARBAMOYL)-5-METHYLPRIDIN-1-IUM | GB002, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | United States;Serbia;France;Canada;Belgium;Singapore;Austria;Australia;Israel;Germany;United Kingdom | ||
4 | NCT03926793 (ClinicalTrials.gov) | February 4, 2020 | 22/4/2019 | Clinical Study of Inhaled GB002 for Treatment of WHO Group I Pulmonary Arterial Hypertension | A Phase 1b, Randomized, Subject- and Investigator-Blinded, Placebo-Controlled, Multi-Center Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Biomarkers of Inhaled GB002 in Subjects With WHO Group 1 Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: GB002;Drug: Placebo;Device: Generic Dry Powder Inhaler | GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. | NULL | Recruiting | 18 Years | 75 Years | All | 16 | Phase 1 | United States;United Kingdom |
5 | EUCTR2018-003093-27-GB (EUCTR) | 16/08/2019 | 12/06/2019 | Clinical Study of Inhaled GB002 for the Treatment of WHO Group I Pulmonary Arterial Hypertension (PAH) | A Phase 1b, Randomized, Subject- and Investigator-Blinded, Placebo-Controlled, Multi-Center Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Biomarkers of Inhaled GB002 in Subjects with WHO Group 1 Pulmonary Arterial Hypertension (PAH) - GB002 in Adult Subjects with PAH | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | GB002, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 16 | Phase 1;Phase 2 | France;United States;Denmark;Netherlands;United Kingdom;Sweden |