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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: MBX 2109 (Part B); Drug: Placebo; Drug: MBX 2109 (Part A)

• Registration Number: NCT05158335
• Lead Sponsor: MBX Biosciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-10
• Study First Submitted: 2021-12-02
• Study First Submitted QC: 2021-12-02
• Study First Posted: 2021-12-15
• Primary Completion: 2023-06-20
• Study Completion: 2023-06-20
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-08
• Last Update Posted: 2023-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
MBX 2109 (Part B)	MBX 2109 (Part B)	Repeated ascending SC doses
Placebo	Placebo	-
MBX 2109 (Part A)	MBX 2109 (Part A)	Single ascending SC doses

Primary Outcome Measures

Name	Time	Method
Primary Outcome Measures	Baseline through Day 40 (part A) or Day 60 (Part B)	Number of participants with adverse events (AEs) or Serious Adverse Events (SAEs)

Secondary Outcome Measures

Name	Time	Method
Secondary Outcome Measures 1	Baseline through Day 40 (part A) or Day 60 (Part B)	Pharmacokinetics (PK): Area Under the Concentration versus Time Curve (AUC) of MBX 2109
Secondary Outcome Measures 2	Baseline through Day 40 (part A) or Day 60 (Part B)	Pharmacodynamics (PD): change from baseline in albumin corrected serum calcium

Trial Locations

Locations (1)

Labcorp Drug Development: Clinical Research Unit; 🇺🇸 Madison, Wisconsin, United States