Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of MBX 1416 in Healthy Subjects
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ClinicalTrials.gov Identifier: NCT06036784 |
Recruitment Status :
Recruiting
First Posted : September 14, 2023
Last Update Posted : February 22, 2024
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Sponsor:
MBX Biosciences
Collaborator:
ProSciento, Inc.
Information provided by (Responsible Party):
MBX Biosciences
Tracking Information | |||||||||
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First Submitted Date ICMJE | August 28, 2023 | ||||||||
First Posted Date ICMJE | September 14, 2023 | ||||||||
Last Update Posted Date | February 22, 2024 | ||||||||
Actual Study Start Date ICMJE | September 18, 2023 | ||||||||
Estimated Primary Completion Date | October 17, 2024 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of MBX 1416 in Healthy Subjects | ||||||||
Official Title ICMJE | A Phase 1 Single and Multiple Ascending Dose and Drug Drug Interaction Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics | ||||||||
Brief Summary | 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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Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 1 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Sequential Assignment Masking: Double (Participant, Investigator) Masking Description: Double Blind Primary Purpose: Basic Science
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Condition ICMJE | Postbariatric Hypoglycemia | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
84 | ||||||||
Original Estimated Enrollment ICMJE |
56 | ||||||||
Estimated Study Completion Date ICMJE | October 17, 2024 | ||||||||
Estimated Primary Completion Date | October 17, 2024 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Part A/B/C Inclusion Criteria:
Part A/B/C Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT06036784 | ||||||||
Other Study ID Numbers ICMJE | MBX-1P2001 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||||
Current Responsible Party | MBX Biosciences | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | MBX Biosciences | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE | ProSciento, Inc. | ||||||||
Investigators ICMJE | Not Provided | ||||||||
PRS Account | MBX Biosciences | ||||||||
Verification Date | February 2024 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |