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

NCT06036784 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2024-12-12

No results posted yet for this study

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

Interventions

DRUG

MBX 1416 (Part A)

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

DRUG

MBX 1416 (Part B)

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

DRUG

Placebo

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

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.

Sponsors & Collaborators

  • ProSciento, Inc.

    collaborator INDUSTRY

  • MBX Biosciences

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-18
Primary Completion
2024-11-14
Completion
2024-12-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06036784 on ClinicalTrials.gov