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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: MBX 2109 (Part A)
* Drug: MBX 2109 (Part B)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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) |