Relative Levels of BMS-986036 in Blood Plasma in Healthy, Overweight, and Obese Participants Following Subcutaneous Administration Via Auto-injector Versus Pre-filled Syringe

NCT04493567 | Completed Phase 1 FDA Drug

• 1 other identifier: MB130-101
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to develop an auto-injector (AI) device for the BMS-986036 subcutaneous formulation that can be self-administered conveniently by participants.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (3)

• Maximum observed serum concentration (Cmax)

  Up to 29 days

• Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]

  Up to 29 days

• Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of C-terminal intact BMS-986036

  Up to 29 days

Secondary Outcomes (16)

• Incidence of adverse events (AEs)

  Up to 115 days

• Incidence of clinically significant changes in clinical laboratory results: Hematology tests

  Up to 85 days

• Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests

  Up to 85 days

• Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests

  Up to 85 days

• Incidence of clinically significant changes in vital signs: Body temperature

  Up to 85 days

Study Arms (2)

Part A: 1 x BMS-986036 via auto-injector or pre-filled syringe

EXPERIMENTAL

Drug: BMS-986036

Part B: 2 x BMS-986036 via auto-injector or pre-filled syringe

EXPERIMENTAL

Drug: BMS-986036

Interventions

BMS-986036 DRUG

Specified dose on specified days

Part A: 1 x BMS-986036 via auto-injector or pre-filled syringe; Part B: 2 x BMS-986036 via auto-injector or pre-filled syringe

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy, overweight, obese, male and female participants, as determined by normal in medical history, physical examination (PE), electrocardiograms (ECGs), and clinical laboratory determinations
• Body mass index (BMI) of 25.0 kg/m2 to 40.0 kg/m2, inclusive i) Approximately 25% of participants will be overweight and have a BMI between 25 kg/m2 and 30 kg/m2, inclusive ii) Approximately 75% of participants will be obese and have a BMI \> 30 kg/m2 to ≤ 40 kg/m2
• Women and men must agree to follow specific methods of contraception, if applicable, while participating in the trial

You may not qualify if:

• Women who are pregnant or breastfeeding
• Inability to tolerate subcutaneous (SC) injections
• Inability to be venipunctured and/or tolerate venous access
• Any sound medical, psychiatric, and/or social reason as determined by the investigator

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (2)

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

ICON (LPRA) - Salt Lake

Salt Lake City, Utah, 84124, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

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: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: July 30, 2020
• Study Start: July 29, 2020
• Primary Completion: June 11, 2021
• Study Completion: June 11, 2021
• Last Updated: March 18, 2022

Record last verified: 2022-03

Locations

US (2)