Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15912(Sonefpeglutide) in Healthy Korean Subjects
A First-in-Human, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15912(Sonefpeglutide) in Healthy Korean Subjects
1 other identifier
interventional
40
1 country
1
Brief Summary
A First-in-Human, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15912 in Healthy Korean Subjects
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2019
CompletedFirst Posted
Study publicly available on registry
September 3, 2019
CompletedStudy Start
First participant enrolled
October 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 3, 2021
CompletedResults Posted
Study results publicly available
February 10, 2025
CompletedFebruary 10, 2025
January 1, 2025
1.1 years
August 26, 2019
March 18, 2022
January 23, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Participants With Treatment-emergent Adverse Events of HM15912
Number of participants with any treatment-emergent adverse events related to study medication.
after single subcutaneous (SC) doses for 44 days
Number of Participants With Significant Findings Observed for Hematology
after single subcutaneous (SC) doses for 44 days
Secondary Outcomes (1)
Concentration Max Profile of HM15912
after single subcutaneous (SC) doses at day 1,2,3,4,5,6,7,10,17 and 30
Study Arms (2)
HM15912
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).
The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).
Eligibility Criteria
You may qualify if:
- Subject voluntarily agrees to participate in this study and signs an IRB-approved informed consent prior to performing any of the Screening visit procedures.
- Korean males and females ≥ 19 and ≤ 60 years of age at the Screening visit
You may not qualify if:
- Subject with a history or presence of clinically significant active diseases.
- Subject who has participated in other clinical studies (including bioequivalence tests) within 6 months before the Screening visit and has received IPs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Asan Medical Center
Seoul, 05505, South Korea
Results Point of Contact
- Title
- Jiyeon Kang
- Organization
- Hanmi Pharmaceutical Co., Ltd.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2019
First Posted
September 3, 2019
Study Start
October 8, 2019
Primary Completion
November 10, 2020
Study Completion
May 3, 2021
Last Updated
February 10, 2025
Results First Posted
February 10, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share