Status:
COMPLETED
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of MBX 1416 in Healthy Subjects
Lead Sponsor:
MBX Biosciences
Collaborating Sponsors:
ProSciento, Inc.
Conditions:
Postbariatric Hypoglycemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- Part A/B/C
- Female and male adults, ages ≥ 18 and ≤ 65 years with a body mass index (BMI) ≥ 18 kg/m² to ≤ 30.0 kg/m² and fasting glucose \< 100 mg/dL and HbA1c \< 5.7%.
- Female subjects of childbearing potential (WOCBP) and male subjects must use highly effective contraception.
- Part A/B/C
Exclusion
- Pregnant, lactating or intending to become pregnant during the study.
- Use of weight-lowering pharmacotherapy or participation in a clinical weight control study within the previous 3 months prior to the first dose of study drug.
- Presence of clinically significant ECG findings
- Subjects with a prior history of any serious adverse reaction, hypersensitivity or angioedema to GLP-1 receptor agonists, study drug or drug components.
- Abnormal laboratory results at Screening.
- History of renal disease or abnormal kidney function tests at Screening
- Presence of any clinically significant physical exam, ECG, or laboratory findings at screening.
Key Trial Info
Start Date :
September 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2024
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT06036784
Start Date
September 18 2023
End Date
December 5 2024
Last Update
December 12 2024
Active Locations (1)
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1
MBX Biosciences Investigational Site
Chula Vista, California, United States, 91911