BBT-401-1S ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
97潰瘍性大腸炎5

97. 潰瘍性大腸炎


臨床試験数 : 2,630 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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PhaseCountries
1NCT04596293
(ClinicalTrials.gov)
June 11, 202115/10/2020Efficacy and Safety of Orally Administered BBT-401-1S in Subjects With Ulcerative ColitisA Randomised, Double-blind, Placebo-controlled Study of Orally Administered BBT-401-1S in Subjects With Moderate to Severe Ulcerative Colitis, Incorporating a Response-adaptive, Double-blind Extension PhaseUlcerative ColitisDrug: BBT-401-1S;Drug: PlaceboBridge Biotherapeutics, Inc.CovanceCompleted18 Years60 YearsAll38Phase 2United States;Korea, Republic of;New Zealand;Poland;Ukraine
2NCT04478825
(ClinicalTrials.gov)
June 1, 202116/7/2020Efficacy and Safety of Rectally Administered BBT-401-1S in Subjects With Ulcerative ColitisAn Open Label, Proof of Mechanism Study to Explore the Efficacy and Safety of Rectally Administered BBT-401-1S in Subjects With Ulcerative ColitisUlcerative ColitisDrug: BBT-401-1SBridge Biotherapeutics, Inc.CovanceTerminated18 Years60 YearsAll2Phase 1New Zealand
3EUCTR2020-003556-33-PL
(EUCTR)
19/04/202117/02/2021A Placebo-controlled Study of BBT-401-1S in Subjects with Moderate to Severe Ulcerative ColitisA Randomised, Double-blind, Placebo-controlled Study of Orally Administered BBT-401-1S in Subjects with Moderate to Severe Ulcerative Colitis, Incorporating a Response-Adaptive, Double-blind Extension Phase Moderate to severe ulcerative colitis.
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: BBT-401-1S
Product Code: BBT-401-1S
INN or Proposed INN: None
Other descriptive name: Sodium (S)-3-(4-hydroxyphenyl)-2-(2-((S)-1-((S)-1-palmitoylpyrrolidine-2-carbonyl)pyrrolidine-2-carboxamido)acetamido)propanoate
Bridge Biotherapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
36Phase 2United States;Poland;Ukraine;New Zealand;Korea, Republic of
4NCT03800420
(ClinicalTrials.gov)
April 22, 20197/1/2019Efficacy and Safety of BBT-401-1S in Ulcerative ColitisA Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of BBT-401-1S in Patients With Active Ulcerative ColitisUlcerative ColitisDrug: BBT-401-1S;Drug: PlaceboBridge Biotherapeutics, Inc.KCRN Research, LLCTerminated18 YearsN/AAll16Phase 2United States
5NCT03482648
(ClinicalTrials.gov)
March 20, 201817/3/2018First-In-Human Study of BBT-401-1S Following Single and Multiple Ascending Doses in Healthy VolunteersA Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of Novel Oral Peptide BBT-401-1S Following Single and Multiple Ascending Doses in Healthy Adult SubjectsUlcerative ColitisDrug: BBT-401-1S, Single dose;Drug: BBT-401-1S, Multiple doses;Drug: PlaceboBridge Biotherapeutics, Inc.KCRN Research, LLCCompleted19 Years55 YearsAll80Phase 1United States