Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of MBX 2109 in Healthy Adult Subjects

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

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-10

Study Completion Date

2023-06-20

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 of MBX 2109 in healthy volunteers.

This study includes 2 parts. Part A involves a single dose of MBX 2109 taken as a subcutaneous (SC) injection just under the skin. Part B involves repeat doses of MBX 2109 taken as a SC injection just under the skin. Each participant will enroll in only one part.

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Detailed Description

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Conditions

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Healthy

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 2109 (Part A)

Single ascending SC doses

Group Type EXPERIMENTAL

MBX 2109 (Part A)

Intervention Type DRUG

Single ascending SC dose of MBX 2109: 50 µg, 150 µg, 300 µg, 460 µg, 600 µg

MBX 2109 (Part B)

Repeated ascending SC doses

Group Type EXPERIMENTAL

MBX 2109 (Part B)

Intervention Type DRUG

Repeated ascending SC doses of MBX 2109: 200 µg, 300 µg, 460 µg, 600 µg, 900 µg

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single SC dose or repeated SC doses of placebo.

Interventions

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MBX 2109 (Part A)

Single ascending SC dose of MBX 2109: 50 µg, 150 µg, 300 µg, 460 µg, 600 µg

Intervention Type DRUG

MBX 2109 (Part B)

Repeated ascending SC doses of MBX 2109: 200 µg, 300 µg, 460 µg, 600 µg, 900 µg

Intervention Type DRUG

Placebo

Single SC dose or repeated SC doses of placebo.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy men and women (of nonchildbearing potential) between 20 and 60 years of age, inclusive.
2. Body mass index between 20.0 and 32.0 kg/m2, inclusive.
3. No clinically meaningful findings on physical examination, electrocardiogram, laboratory tests or vital signs
4. Subject has been given signed informed consent

Exclusion Criteria

1. History of any significant illness or disorder
2. Acute illness within 30 days of administration of first dose of study drug
3. Positive screening result for HIV, hepatitis B or hepatitis C
4. History of or current substance abuse (drug or alcohol) within past 1 year or positive test for drugs of abuse during screening
5. Use of nicotine-containing or vaping products within 3 months prior to screening or check-in
6. Use of cannabis within 45 days prior to check-in
7. Donation of blood within 3 months prior to screening, plasma within 2 weeks prior to screening or platelets within 6 weeks prior to screening
8. Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within past 30 days

Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes