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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT05158335

Run by

MBX Biosciences

People needed

76

Starts

2021-11-10

Expected to finish

2023-06-20

Last updated by the study team

2023-08-09

Who can join

Age: 21 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Labcorp Drug Development: Clinical Research Unit — Dallas, Texas, United States
• Labcorp Drug Development: Clinical Research Unit — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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