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

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).

Full Title of Study: “A First-in-Human, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM15136 in Healthy Subjects”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Double (Participant, Investigator)
• Study Primary Completion Date: August 29, 2019

Interventions

• Drug: HM15136
  • 10 mg/mL as protein in prefilled syringes
• Drug: Placebo of HM15136
  • Placebo in prefilled syringes

Arms, Groups and Cohorts

• Experimental: HM15136
• Placebo Comparator: Placebo of HM15136

Clinical Trial Outcome Measures

Primary Measures

• Adverse Event
  • Time Frame: Day 30
  • Incidence of adverse events

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Hanmi Pharmaceutical Company Limited
• Provider of Information About this Clinical Study
  • Sponsor