NCT02145234|CompletedPhase 1

Placebo-Controlled, Single and Multiple Ascending Subcutaneous Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986089 in Healthy Adult Subjects

A Randomized, Placebo-Controlled, Single and Multiple Ascending Subcutaneous Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986089 in Healthy Adult Subjects

Hoffmann-La Roche ClinicalTrials.gov

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1 other identifier

CN001-001

Study Type

interventional

Target

140

Locations

1 country

Sites

Timeline

RegisteredMay 2014

StartedJun 2014

CompletionFeb 2016

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of single and multiple doses of BMS-986089 in healthy adult subjects.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

140

participants targeted

Target at P75+ for phase_1

Timeline

Completed

Started Jun 2014

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.7 years study duration

First Submitted

Initial submission to the registry

May 16, 2014

Completed

6 days until next milestone

First Posted

Study publicly available on registry

May 22, 2014

Completed

1 month until next milestone

Study Start

First participant enrolled

June 30, 2014

Completed

1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2016

Completed

Last Updated

September 7, 2017

Status Verified

September 1, 2017

Enrollment Period

1.7 years

First QC Date

May 16, 2014

Last Update Submit

September 5, 2017

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (2)

Safety endpoints, including incidence of Adverse Event (AEs), serious AEs, AEs leading to discontinuation or death, as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, and physical examinations
Single Ascending Dose (SAD) Phase 119 days
Safety endpoints, including incidence of Adverse Event (AEs), serious AEs, AEs leading to discontinuation or death, as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, and physical examinations
Multiple Ascending Dose (MAD) phase 148 days

Secondary Outcomes (19)

Maximum observed serum concentration (Cmax) for SAD and MAD
SAD phase: Day1 to Day 91, MAD phase: Day 1 to Day 120
Time of maximum observed serum concentration (Tmax) for SAD and MAD
SAD phase: Day1 to Day 91, MAD phase: Day 1 to Day 120
Serum concentration 168 h post dose (C(168H)) for SAD and MAD
SAD phase: Day1 to Day 91, MAD phase: Day 1 to Day 120
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) for SAD
SAD phase: Day1 to Day 91
Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) for SAD
SAD phase: Day1 to Day 91
+14 more secondary outcomes

Study Arms (12)

SAD Panel 1:BMS-986089/Placebo

EXPERIMENTAL

BMS-986089 in a single subcutaneous administration OR Placebo matching with BMS-986089 in a single subcutaneous administration