NCT05158335

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

A Phase 1, Randomized, Double Blind, Placebo Controlled, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of Single and Multiple Ascending Doses of MBX 2109 in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: MBX Biosciences · Industry
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	MBX 2109 (Part A)	Single ascending SC dose of MBX 2109: 50 µg, 150 µg, 300 µg, 460 µg, 600 µg
DRUG	MBX 2109 (Part B)	Repeated ascending SC doses of MBX 2109: 200 µg, 300 µg, 460 µg, 600 µg, 900 µg
DRUG	Placebo	Single SC dose or repeated SC doses of placebo.

Timeline

• Start date: 2021-11-10
• Primary completion: 2023-06-20
• Completion: 2023-06-20
• First posted: 2021-12-15
• Last updated: 2023-08-09

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study