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

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.

Study Overview

• Status: Completed
• Conditions: Postbariatric Hypoglycemia
• Intervention / Treatment: Drug: MBX 1416 (Part B); Drug: Placebo; Drug: MBX 1416 (Part A); Drug: MBX 1416 (Part C)

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Chula Vista, California, United States, 91911
      • MBX Biosciences Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Part A/B/C 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Single dose or repeated subcutaneous (SC) dose of placebo.
Experimental: MBX 1416 (Part A); Single ascending subcutaneous (SC) doses	Drug: MBX 1416 (Part A); Single Ascending subcutaneous (SC) dose of MBX 1416: 10mg, 30mg,100mg, 200mg
Experimental: MBX 1416 (Part B); Repeated ascending subcutaneous (SC) doses	Drug: MBX 1416 (Part B); Repeated ascending subcutaneous (SC) doses of MBX 1416: 10mg, 30mg, 100mg
Experimental: MBX 1416 (Part C); Single subcutaneous (SC) dose of MBX 1416, single dose of rosuvastatin and acetaminophen.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: MBX Biosciences
• Collaborators: ProSciento, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2023
• Primary Completion (Actual): November 14, 2024
• Study Completion (Actual): December 5, 2024

Study Registration Dates

• First Submitted: August 28, 2023
• First Submitted That Met QC Criteria: September 11, 2023
• First Posted (Actual): September 14, 2023

Study Record Updates

• Last Update Posted (Estimated): December 12, 2024
• Last Update Submitted That Met QC Criteria: December 9, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Hypoglycemia
• Other Study ID Numbers: MBX-1P2001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No