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OpenTrials
Completed

NCT Number: NCT06036784

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

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.

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Key information

Conditions

Postbariatric Hypoglycemia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

MBX Biosciences Investigational Site

Chula Vista, California, 91911, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Part A/B/C Inclusion Criteria:

  • 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.

Part A/B/C Exclusion Criteria:

  • 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.

Treatment and study plan

MBX 1416 (Part A)

Drug

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

MBX 1416 (Part B)

Drug

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

Placebo

Drug

Single dose or repeated subcutaneous (SC) dose of 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.

Primary outcomes

  1. Number of participants with adverse events (AEs), Serious Adverse Events (SAEs)

    Time frame: Baseline through Day 29 (Part A) or Day 45 (Part B) and Day 21 (Part C)

  2. Maximum Plasma Concentration (Cmax)

    Time frame: Baseline through Day 29 (Part A) or Day 45 (Part B) and Day 21 (Part C)

Sponsors and collaborators

Lead sponsor

MBX Biosciences

Industry

Collaborators

  • ProSciento, Inc.

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 14, 2023
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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