A First-in-Human, Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM15136 in Healthy Subjects
Sponsor
Hanmi Pharmaceutical Company Limited (Industry)
Overall Status
Completed
CT.gov ID
NCT04032782
Collaborator
(none)
40
1
2
10.9
3.7
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date
:
Oct 2, 2018
Actual Primary Completion Date
:
Aug 29, 2019
Actual Study Completion Date
:
Aug 29, 2019
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Adverse Event [Day 30]
Incidence of adverse events
Eligibility Criteria
Criteria
Ages Eligible for Study:
19 Years
to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul National University Hospital | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Hanmi Pharmaceutical Company Limited
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT04032782
Other Study ID Numbers:
- HM-GCG-101
First Posted:
Jul 25, 2019
Last Update Posted:
Mar 21, 2022
Last Verified:
Mar 1, 2022
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