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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: MBX 2109 (Part A); Drug: MBX 2109 (Part B)

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Irene Mirkin, MD; Phone Number: (608) 442-8200; Email: Irene.Mirkin@labcorp.com

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75247
      • Labcorp Drug Development: Clinical Research Unit
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Labcorp Drug Development: Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Single SC dose or repeated SC doses of placebo.
Experimental: MBX 2109 (Part A); Single ascending SC doses	Drug: MBX 2109 (Part A); Single ascending SC dose of MBX 2109: 50 µg, 150 µg, 300 µg, 460 µg, 600 µg
Experimental: MBX 2109 (Part B); Repeated ascending SC doses	Drug: MBX 2109 (Part B); Repeated ascending SC doses of MBX 2109: 200 µg, 300 µg, 460 µg, 600 µg, 900 µg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures 2	Pharmacodynamics (PD): change from baseline in albumin corrected serum calcium	Baseline through Day 40 (part A) or Day 60 (Part B)

Collaborators and Investigators

• Sponsor: MBX Biosciences
• Investigators: Study Director: Mary Jane Geiger, MD, PhD, MBX Biosciences

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2021
• Primary Completion (Actual): June 20, 2023
• Study Completion (Actual): June 20, 2023

Study Registration Dates

• First Submitted: December 2, 2021
• First Submitted That Met QC Criteria: December 2, 2021
• First Posted (Actual): December 15, 2021

Study Record Updates

• Last Update Posted (Actual): August 9, 2023
• Last Update Submitted That Met QC Criteria: August 8, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: MBX-2H1001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No