Phase 1
Completed N=40
Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15912(Sonefpeglutide) in Healthy Korean Subjects
Pharmacology
Source: ClinicalTrials.gov NCT04076293 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcomePrimary: Number of Participants With Treatment-emergent Adverse Events of HM15912 — 3; 1; 2; 4 Participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events of HM15912 |
3; 1; 2; 4; 4; 5 | — |
| PRIMARY Number of Participants With Significant Findings Observed for Hematology |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Concentration Max Profile of HM15912 |
249.45; 622.46; 3550.79; 8347.70; 9393.06; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04076293). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.