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

Hanmi Pharmaceutical Company Limited40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pharmacology

Interventions

HM15136DRUG

10 mg/mL as protein in prefilled syringes

Placebo of HM15136DRUG

Placebo in prefilled syringes

Eligibility

Sex: ALLMin age: 19 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Adverse Event

Incidence of adverse events

Time frame: Day 30

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.