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NCT04032782 Clinical Trial

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

Pharmacology Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04032782
Other study ID # HM-GCG-101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 2, 2018
Est. completion date August 29, 2019

Study information
Verified date March 2022
Source Hanmi Pharmaceutical Company Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date August 29, 2019
Est. primary completion date August 29, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 60 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse Event Incidence of adverse events Day 30
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