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

Phase 1

Completed

• Conditions: Pharmacology
• Interventions: Drug: HM15136; Drug: Placebo of HM15136

• Registration Number: NCT04032782
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-02
• Study First Submitted: 2018-11-16
• Study First Submitted QC: 2019-07-24
• Study First Posted: 2019-07-25
• Primary Completion: 2019-08-29
• Study Completion: 2019-08-29
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HM15136	HM15136	-
Placebo of HM15136	Placebo of HM15136	-

Primary Outcome Measures

Name	Time	Method
Adverse Event	Day 30	Incidence of adverse events

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of