NCT06036784

Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of MBX 1416 in Healthy Subjects

A Phase 1 Single and Multiple Ascending Dose and Drug Drug Interaction Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: MBX Biosciences · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses and Drug Drug Interaction of MBX 1416 in healthy volunteers This study includes 3 parts. Part A involves a single dose of MBX 1416 or placebo taken as a subcutaneous injection (SC). Part B involves repeat doses of MBX 1416 or placebo taken as a subcutaneous injection (SC). Part C involves the evaluation of rosuvastatin and acetaminophen pharmacokinetics in the presence and absence of MBX 1416.

Conditions

• Postbariatric Hypoglycemia

Interventions

Type	Name	Description
DRUG	MBX 1416 (Part A)	Single Ascending subcutaneous (SC) dose of MBX 1416: 10mg, 30mg,100mg, 200mg
DRUG	MBX 1416 (Part B)	Repeated ascending subcutaneous (SC) doses of MBX 1416: 10mg, 30mg, 100mg
DRUG	Placebo	Single dose or repeated subcutaneous (SC) dose of placebo.
DRUG	MBX 1416 (Part C)	Single subcutaneous (SC) dose of MBX 1416 and the single dose of rosuvastatin and acetaminophen pharmacokinetics. The doses selected for MBX 1416 in Part C will not exceed a dose of 200mg.

Timeline

• Start date: 2023-09-18
• Primary completion: 2024-11-14
• Completion: 2024-12-05
• First posted: 2023-09-14
• Last updated: 2024-12-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study