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

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Pharmacology

Treatments: Drug: Placebo of HM15136; Drug: HM15136

Study type: Interventional

Funder types: Industry

Identifiers

NCT04032782

HM-GCG-101

Details and patient eligibility

About

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).

Enrollment: 40 patients

Sex: All

Ages: 19 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

HM15136

Experimental group

Treatment:

Drug: HM15136

Placebo of HM15136

Placebo Comparator group

Treatment:

Drug: Placebo of HM15136