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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06036784

Enrollment

Registered

2023-09-14

Start date

2023-09-18

Completion date

2024-12-05

Last updated

2024-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postbariatric Hypoglycemia

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.

Interventions

DRUGMBX 1416 (Part A)

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

DRUGMBX 1416 (Part B)

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

DRUGPlacebo

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

DRUGMBX 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.

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Masking description

Double Blind

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

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.

Design outcomes

Primary

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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026