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

NCT06036784 | Completed Phase 1 FDA Drug

• 1 other identifier: MBX-1P2001
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Postbariatric Hypoglycemia

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (4)

MBX 1416 (Part A)

EXPERIMENTAL

Single ascending subcutaneous (SC) doses

Drug: MBX 1416 (Part A)

MBX 1416 (Part B)

EXPERIMENTAL

Repeated ascending subcutaneous (SC) doses

Drug: MBX 1416 (Part B)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

MBX 1416 (Part C)

EXPERIMENTAL

Single subcutaneous (SC) dose of MBX 1416, single dose of rosuvastatin and acetaminophen.

Drug: MBX 1416 (Part C)

Interventions

MBX 1416 (Part A) DRUG

Single Ascending subcutaneous (SC) dose of MBX 1416: 10mg, 30mg,100mg, 200mg

MBX 1416 (Part A)

MBX 1416 (Part B) DRUG

Repeated ascending subcutaneous (SC) doses of MBX 1416: 10mg, 30mg, 100mg

MBX 1416 (Part B)

Placebo DRUG

Single dose or repeated subcutaneous (SC) dose of placebo.

Placebo

MBX 1416 (Part C) DRUG

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.

MBX 1416 (Part C)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.
• Female subjects of childbearing potential (WOCBP) and male subjects must use highly effective contraception.

You may not qualify if:

• Pregnant, lactating or intending to become pregnant during the study.
• 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.
• Presence of clinically significant ECG findings
• Subjects with a prior history of any serious adverse reaction, hypersensitivity or angioedema to GLP-1 receptor agonists, study drug or drug components.
• Abnormal laboratory results at Screening.
• History of renal disease or abnormal kidney function tests at Screening
• Presence of any clinically significant physical exam, ECG, or laboratory findings at screening.

Sponsors & Collaborators

• MBX Biosciences: lead
• ProSciento, Inc.: collaborator

Study Sites (1)

MBX Biosciences Investigational Site

Chula Vista, California, 91911, United States

Location

Related Publications (1)

• Fabbrini E, Koshkina A, Hackett M, Zhao M, Thalluri K, Hompesch M, Macias A, Schneider K, D'Alessio DA, DiMarchi RD, Azoulay S. Sustained Action of Imapextide, a Glucagon-Like Peptide-1 Receptor Antagonist, in Healthy Volunteers. J Clin Endocrinol Metab. 2025 Dec 24:dgaf691. doi: 10.1210/clinem/dgaf691. Online ahead of print.

  PMID: 41437319 DERIVED

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: August 28, 2023
• First Posted: September 14, 2023
• Study Start: September 18, 2023
• Primary Completion: November 14, 2024
• Study Completion: December 5, 2024
• Last Updated: December 12, 2024

Record last verified: 2024-12

Locations

US (1)