NCT04032782CompletedPhase 1
A First-in-Human, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM15136(Efpegerglucagon) in Healthy Subjects
Hanmi Pharmaceutical Company Limited1 site in 1 country40 target enrollmentStarted: October 2, 2018Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Adverse Event
Study Overview
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.
The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15136 or placebo in a ratio of 6:2 (6 active, 2 placebo).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 19 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Body mass index ≥ 18.5 and ≤ 27 kg/m2 and with a weight ≥ 50 kg
Exclusion Criteria
- •with personal or family history of hypercoagulability or thromboembolic disease
- •has had treatment with any incretin therapy
- •has FPG < 70 or > 110 mg/dL
Arms & Interventions
HM15136
Experimental
Intervention: HM15136 (Drug)
Placebo of HM15136
Placebo Comparator
Intervention: Placebo of HM15136 (Drug)
Outcomes
Primary Outcomes
Adverse Event
Time Frame: Day 30
Incidence of adverse events
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
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