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

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

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 Overview

• Status: Completed
• Conditions: Pharmacology
• Intervention / Treatment: Drug: HM15136; Drug: Placebo of HM15136

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HM15136	Drug: HM15136; 10 mg/mL as protein in prefilled syringes
Placebo Comparator: Placebo of HM15136	Drug: Placebo of HM15136; Placebo in prefilled syringes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Event	Incidence of adverse events	Day 30

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2018
• Primary Completion (Actual): August 29, 2019
• Study Completion (Actual): August 29, 2019

Study Registration Dates

• First Submitted: November 16, 2018
• First Submitted That Met QC Criteria: July 24, 2019
• First Posted (Actual): July 25, 2019

Study Record Updates

• Last Update Posted (Actual): March 21, 2022
• Last Update Submitted That Met QC Criteria: March 18, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: HM-GCG-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No