NCT03198182

Brief Summary

The purpose of this study is to evaluate safety, and tolerability of BMS-986036 and the effects the drug has on the body

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2017

Shorter than P25 for phase_1

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

First Submitted

Initial submission to the registry

June 22, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 26, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

June 28, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2017

Completed
Last Updated

May 1, 2019

Status Verified

April 1, 2019

Enrollment Period

3 months

First QC Date

June 22, 2017

Last Update Submit

April 29, 2019

Conditions

Metabolics

Outcome Measures

Primary Outcomes (2)

  • Incidence of adverse events (AEs)

    Safety

    Up to 42 days

  • Incidence of serious adverse events (SAEs)

    Safety

    Up to 42 days

Study Arms (2)

Module A

EXPERIMENTAL

BMS-986036 Arm

Drug: BMS-986036

Module B

PLACEBO COMPARATOR

Placebo Arm

Drug: Placebo

Interventions

PlaceboDRUG

Specified dose on specified days

Module B
BMS-986036DRUG

Specified dose on specified days

Module A

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects, as determined by no clinically significant deviations from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
  • Body mass index (BMI) of 25 to 40 kilogram / square meter (kg/m2), inclusive
  • Additional criterion for Japanese subjects: Subjects must be first generation Japanese (born in Japan and not living outside of Japan for \> 10 years, and both parents are ethnically Japanese)

You may not qualify if:

  • Presence of any factors that would predispose the subject to infection (extensive periodontal disease that warrants surgical or medical treatment, unhealed open wounds)
  • Any bone trauma (fracture) or bone surgery (hardware placement, joint replacement, bone grafting, or amputation) within 3 months of study drug administration
  • Known or suspected autoimmune disorder, excluding vitiligo

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WCCT Global

Cypress, California, 90630, United States

Location

Related Links

MeSH Terms

Interventions

Pegbelfermin

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2017

First Posted

June 26, 2017

Study Start

June 28, 2017

Primary Completion

September 22, 2017

Study Completion

September 22, 2017

Last Updated

May 1, 2019

Record last verified: 2019-04

Locations

US(1)