Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of MBX 2109 in Healthy Adult Subjects

NCT05158335 | Completed Phase 1 FDA Drug

• 1 other identifier: MBX-2H1001
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of MBX 2109 in healthy volunteers. This study includes 2 parts. Part A involves a single dose of MBX 2109 taken as a subcutaneous (SC) injection just under the skin. Part B involves repeat doses of MBX 2109 taken as a SC injection just under the skin. Each participant will enroll in only one part.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Measures

  Number of participants with adverse events (AEs) or Serious Adverse Events (SAEs)

  Baseline through Day 40 (part A) or Day 60 (Part B)

Secondary Outcomes (2)

• Secondary Outcome Measures 1

  Baseline through Day 40 (part A) or Day 60 (Part B)

• Secondary Outcome Measures 2

  Baseline through Day 40 (part A) or Day 60 (Part B)

Study Arms (3)

MBX 2109 (Part A)

EXPERIMENTAL

Single ascending SC doses

Drug: MBX 2109 (Part A)

MBX 2109 (Part B)

EXPERIMENTAL

Repeated ascending SC doses

Drug: MBX 2109 (Part B)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

MBX 2109 (Part A) DRUG

Single ascending SC dose of MBX 2109: 50 µg, 150 µg, 300 µg, 460 µg, 600 µg

MBX 2109 (Part A)

MBX 2109 (Part B) DRUG

Repeated ascending SC doses of MBX 2109: 200 µg, 300 µg, 460 µg, 600 µg, 900 µg

MBX 2109 (Part B)

Placebo DRUG

Single SC dose or repeated SC doses of placebo.

Placebo

Eligibility Criteria

• Age: 21 Years - 60 Years
• Gender Eligibility Details: Men and women of non-child bearing potential
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy men and women (of nonchildbearing potential) between 20 and 60 years of age, inclusive.
• Body mass index between 20.0 and 32.0 kg/m2, inclusive.
• No clinically meaningful findings on physical examination, electrocardiogram, laboratory tests or vital signs
• Subject has been given signed informed consent

You may not qualify if:

• History of any significant illness or disorder
• Acute illness within 30 days of administration of first dose of study drug
• Positive screening result for HIV, hepatitis B or hepatitis C
• History of or current substance abuse (drug or alcohol) within past 1 year or positive test for drugs of abuse during screening
• Use of nicotine-containing or vaping products within 3 months prior to screening or check-in
• Use of cannabis within 45 days prior to check-in
• Donation of blood within 3 months prior to screening, plasma within 2 weeks prior to screening or platelets within 6 weeks prior to screening
• Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within past 30 days

Sponsors & Collaborators

• MBX Biosciences: lead

Study Sites (2)

Labcorp Drug Development: Clinical Research Unit

Dallas, Texas, 75247, United States

Location

Labcorp Drug Development: Clinical Research Unit

Madison, Wisconsin, 53704, United States

Location

Study Officials

• Mary Jane Geiger, MD, PhD

  MBX Biosciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double Blind
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: December 15, 2021
• Study Start: November 10, 2021
• Primary Completion: June 20, 2023
• Study Completion: June 20, 2023
• Last Updated: August 9, 2023

Record last verified: 2023-08

Locations

US (2)