Single Ascending Dose and Multiple Ascending Dose Study in Healthy Participants and Proof of Mechanism Study in Patients With Ulcerative Colitis
NCT02864264 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7
Last updated 2017-10-20
Summary
The primary purpose of this study is to determine if single and multiple doses of BMS-986184 are safe and well tolerated in healthy male and female subjects. The primary purpose of the proof of mechanism study is to determine safety and efficacy in patients with ulcerative colitis.
Conditions
- Healthy Volunteers
- Ulcerative Colitis
Interventions
- DRUG
-
BMS-986184
- DRUG
-
Placebo matching BMS-986184
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SCREENING
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-09-14
- Primary Completion
- 2017-09-27
- Completion
- 2017-09-27
- FDA Drug
- Yes
Countries
- Australia
- Georgia
- Moldova
Study Locations
More Related Trials
-
A Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of rhuMAb Beta7 in Patients With Ulcerative Colitis
NCT00694980 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative Colitis
NCT02958865 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative Colitis
NCT01336465 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Tolerability, Efficacy and Dose-response of GSK2831781 in Ulcerative Colitis
NCT03893565 ·Status: TERMINATED ·Phase: PHASE2
-
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC)
NCT06979336 ·Status: RECRUITING ·Phase: PHASE2
-
Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis
NCT06290934 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects and Subjects With Mild to Moderate Ulcerative Colitis
NCT01164904 ·Status: TERMINATED ·Phase: PHASE1
-
An Efficacy and Safety Study of LYC-30937-EC in Subjects With Active Ulcerative Colitis
NCT02762500 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase II Study in Patients With Moderate to Severe Active Ulcerative Colitis.
NCT03675477 ·Status: COMPLETED ·Phase: PHASE2
-
A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors
NCT02171429 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Safety and Effectiveness of JNJ-54781532 in Patients With Moderately to Severely Active Ulcerative Colitis
NCT01959282 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of GLPG0974 in Subjects With Ulcerative Colitis
NCT01829321 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GS-5745 (Andecaliximab) in Adults With Moderate to Severe Active Ulcerative Colitis
NCT01831427 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy, Pharmacokinetics, Tolerability, Safety of SB012 Intrarectally Applied in Active Ulcerative Colitis Patients
NCT02129439 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
GI-270384 Study In Patients With Mild To Moderate Ulcerative Colitis
NCT00457171 ·Status: TERMINATED ·Phase: PHASE1
-
Efficacy and Safety of BBT-401-1S in Ulcerative Colitis
NCT03800420 ·Status: TERMINATED ·Phase: PHASE2
-
Study to Evaluate the Clinical Activity and Safety of Oral NX-13 in Moderate to Severe Ulcerative Colitis
NCT05785715 ·Status: TERMINATED ·Phase: PHASE2
-
Effect of GSK1399686 in Patients With Mild to Moderately Active Ulcerative Colitis
NCT01036022 ·Status: COMPLETED ·Phase: PHASE2
-
GB004 in Adult Subjects With Active Ulcerative Colitis
NCT03860896 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis
NCT06049017 ·Status: COMPLETED ·Phase: PHASE2
-
A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors
NCT02163759 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase 2a, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of IBD98-M
NCT02493712 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of MK-6194 (PT101) in Participants With Active Ulcerative Colitis (UC) (MK-6194-002)
NCT04924114 ·Status: COMPLETED ·Phase: PHASE1
-
GSK2982772 Study in Subjects With Ulcerative Colitis
NCT02903966 ·Status: COMPLETED ·Phase: PHASE2
-
ABTECT-1 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -1
NCT05507203 ·Status: COMPLETED ·Phase: PHASE3