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| Name | Class |
|---|---|
| ProSciento, Inc. | INDUSTRY |
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The purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses and Drug Drug Interaction of MBX 1416 in healthy volunteers
This study includes 3 parts. Part A involves a single dose of MBX 1416 or placebo taken as a subcutaneous injection (SC). Part B involves repeat doses of MBX 1416 or placebo taken as a subcutaneous injection (SC). Part C involves the evaluation of rosuvastatin and acetaminophen pharmacokinetics in the presence and absence of MBX 1416.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBX 1416 (Part A) | Experimental | Single ascending subcutaneous (SC) doses |
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| MBX 1416 (Part B) | Experimental | Repeated ascending subcutaneous (SC) doses |
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| Placebo | Placebo Comparator |
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| MBX 1416 (Part C) | Experimental | Single subcutaneous (SC) dose of MBX 1416, single dose of rosuvastatin and acetaminophen. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MBX 1416 (Part A) | Drug | Single Ascending subcutaneous (SC) dose of MBX 1416: 10mg, 30mg,100mg, 200mg |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs), Serious Adverse Events (SAEs) | Baseline through Day 29 (Part A) or Day 45 (Part B) and Day 21 (Part C) | |
| Maximum Plasma Concentration (Cmax) | Baseline through Day 29 (Part A) or Day 45 (Part B) and Day 21 (Part C) |
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Part A/B/C Inclusion Criteria:
Part A/B/C Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MBX Biosciences Investigational Site | Chula Vista | California | 91911 | United States |
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Double Blind
| MBX 1416 (Part B) | Drug | Repeated ascending subcutaneous (SC) doses of MBX 1416: 10mg, 30mg, 100mg |
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| Placebo | Drug | Single dose or repeated subcutaneous (SC) dose of placebo. |
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| MBX 1416 (Part C) | Drug | Single subcutaneous (SC) dose of MBX 1416 and the single dose of rosuvastatin and acetaminophen pharmacokinetics. The doses selected for MBX 1416 in Part C will not exceed a dose of 200mg. |
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