Status:
COMPLETED
A First-in-Human, Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM15136(Efpegerglucagon) in Healthy Subjects
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Pharmacology
Eligibility:
All Genders
19-60 years
Phase:
PHASE1
Brief Summary
This is a double-blind, randomized, placebo controlled, single ascending dose (SAD) study to investigate the safety, tolerability, PK and PD of the SC administration of HM15136 in healthy subjects. T...
Eligibility Criteria
Inclusion
- Body mass index ≥ 18.5 and ≤ 27 kg/m2 and with a weight ≥ 50 kg
Exclusion
- with personal or family history of hypercoagulability or thromboembolic disease
- has had treatment with any incretin therapy
- has FPG \< 70 or \> 110 mg/dL
Key Trial Info
Start Date :
October 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 29 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04032782
Start Date
October 2 2018
End Date
August 29 2019
Last Update
February 5 2025
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea