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

NCT ID: NCT06036784

Last Updated: 2024-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-18

Study Completion Date

2024-12-05

Brief Summary

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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.

Detailed Description

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Conditions

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Postbariatric Hypoglycemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators
Double Blind

Study Groups

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MBX 1416 (Part A)

Single ascending subcutaneous (SC) doses

Group Type EXPERIMENTAL

MBX 1416 (Part A)

Intervention Type DRUG

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

MBX 1416 (Part B)

Repeated ascending subcutaneous (SC) doses

Group Type EXPERIMENTAL

MBX 1416 (Part B)

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

MBX 1416 (Part C)

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

Group Type EXPERIMENTAL

MBX 1416 (Part C)

Intervention Type 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.

Interventions

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MBX 1416 (Part A)

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

Intervention Type DRUG

MBX 1416 (Part B)

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

Intervention Type DRUG

Placebo

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

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ProSciento, Inc.

INDUSTRY

Sponsor Role collaborator

MBX Biosciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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MBX Biosciences Investigational Site

Chula Vista, California, United States

Site Status

Countries

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United States

Other Identifiers

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MBX-1P2001

Identifier Type: -

Identifier Source: org_study_id