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

MBX Biosciences

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: MBX 2109 (Part A); Drug: MBX 2109 (Part B); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05158335

MBX-2H1001

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 21 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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76 participants in 3 patient groups, including a placebo group

MBX 2109 (Part A)

Experimental group

Description:

Single ascending SC doses

Treatment:

Drug: MBX 2109 (Part A)

MBX 2109 (Part B)

Experimental group

Description:

Repeated ascending SC doses

Treatment:

Drug: MBX 2109 (Part B)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo