CompletedPhase 1

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

United States69 participantsStarted 2023-09-18

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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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.

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.

What they're measuring

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

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

Maximum Plasma Concentration (Cmax)

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

Trial details

NCT IDNCT06036784

SponsorMBX Biosciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-11-14

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