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

Phase 1

Completed

• Conditions: Postbariatric Hypoglycemia
• Interventions: Drug: MBX 1416 (Part A); Drug: MBX 1416 (Part B); Drug: MBX 1416 (Part C); Drug: Placebo

• Registration Number: NCT06036784
• Lead Sponsor: MBX Biosciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-28
• Study First Submitted QC: 2023-09-11
• Study First Posted: 2023-09-14
• Study Start: 2023-09-18
• Primary Completion: 2024-11-14
• Status Verified: 2024-12
• Study Completion: 2024-12-05
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

1. Female and male adults, ages ≥ 18 and ≤ 65 years with a body mass index (BMI) ≥ 18 kg/m² to ≤ 30.0 kg/m² and fasting glucose < 100 mg/dL and HbA1c < 5.7%.
2. Female subjects of childbearing potential (WOCBP) and male subjects must use highly effective contraception.

Part A/B/C

Exclusion Criteria

1. Pregnant, lactating or intending to become pregnant during the study.
2. Use of weight-lowering pharmacotherapy or participation in a clinical weight control study within the previous 3 months prior to the first dose of study drug.
3. Presence of clinically significant ECG findings
4. Subjects with a prior history of any serious adverse reaction, hypersensitivity or angioedema to GLP-1 receptor agonists, study drug or drug components.
5. Abnormal laboratory results at Screening.
6. History of renal disease or abnormal kidney function tests at Screening
7. Presence of any clinically significant physical exam, ECG, or laboratory findings at screening.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
MBX 1416 (Part A)	MBX 1416 (Part A)	Single ascending subcutaneous (SC) doses
MBX 1416 (Part B)	MBX 1416 (Part B)	Repeated ascending subcutaneous (SC) doses
MBX 1416 (Part C)	MBX 1416 (Part C)	Single subcutaneous (SC) dose of MBX 1416, single dose of rosuvastatin and acetaminophen.
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events (AEs), Serious Adverse Events (SAEs)	Baseline through Day 29 (Part A) or Day 45 (Part B) and Day 21 (Part C)
Maximum Plasma Concentration (Cmax)	Baseline through Day 29 (Part A) or Day 45 (Part B) and Day 21 (Part C)

Trial Locations

Locations (1)

MBX Biosciences Investigational Site; 🇺🇸 Chula Vista, California, United States