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drugset / Trial / NCT04032782

A First-in-Human, Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM15136(Efpegerglucagon) in Healthy Subjects

NCT04032782 ↗

Phase 1 Completed 40 enrolled Hanmi Pharmaceutical Company Limited
RandomizedParallel-groupDouble-blindTreatment

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).

Timeline

Start
2018-10-02
Primary completion
2019-08-29
Completion
2019-08-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Efpegerglucagon Protein / enzyme biologic 10 mg/ml Subcutaneous

Indications

No indication recorded.