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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBX 2109 (Part A) | Experimental | Single ascending SC doses |
|
| MBX 2109 (Part B) | Experimental | Repeated ascending SC doses |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MBX 2109 (Part A) | Drug | Single ascending SC dose of MBX 2109: 50 µg, 150 µg, 300 µg, 460 µg, 600 µg |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Men and women of non-child bearing potential
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| Name | Affiliation | Role |
|---|---|---|
| Mary Jane Geiger, MD, PhD | MBX Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Labcorp Drug Development: Clinical Research Unit | Dallas | Texas | 75247 | United States | ||
| Labcorp Drug Development: Clinical Research Unit |
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Double Blind
| MBX 2109 (Part B) | Drug | Repeated ascending SC doses of MBX 2109: 200 µg, 300 µg, 460 µg, 600 µg, 900 µg |
|
| Placebo | Drug | Single SC dose or repeated SC doses of placebo. |
|
Pharmacodynamics (PD): change from baseline in albumin corrected serum calcium
| Baseline through Day 40 (part A) or Day 60 (Part B) |
| Madison |
| Wisconsin |
| 53704 |
| United States |