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

Healthy Clinical Trial

Official title:

A Phase 1, Randomized, Double Blind, Placebo Controlled, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of Single and Multiple Ascending Doses of MBX 2109 in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05158335
• Other study ID #: MBX-2H1001
• Status: Completed
• Phase: Phase 1
• Start date: November 10, 2021
• Est. completion date: June 20, 2023

Study information

• Verified date: August 2023
• Source: MBX Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: June 20, 2023
• Est. primary completion date: June 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• MBX 2109 (Part A)
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 of MBX 2109: 200 µg, 300 µg, 460 µg, 600 µg, 900 µg
• Placebo
Single SC dose or repeated SC doses of placebo.

Locations

Country	Name	City	State
United States	Labcorp Drug Development: Clinical Research Unit	Dallas	Texas
United States	Labcorp Drug Development: Clinical Research Unit	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
MBX Biosciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome Measures	Number of participants with adverse events (AEs) or Serious Adverse Events (SAEs)	Baseline through Day 40 (part A) or Day 60 (Part B)
Secondary	Secondary Outcome Measures 1	Pharmacokinetics (PK): Area Under the Concentration versus Time Curve (AUC) of MBX 2109	Baseline through Day 40 (part A) or Day 60 (Part B)
Secondary	Secondary Outcome Measures 2	Pharmacodynamics (PD): change from baseline in albumin corrected serum calcium	Baseline through Day 40 (part A) or Day 60 (Part B)