CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 40 enrolled
Drug / intervention
HM15912 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04076293
NCT04076293Phase 1Completed
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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

Hanmi Pharmaceutical Company Limited·interventional·Posted Sep 3, 2019·Updated Feb 10, 2025

In Brief

A Phase 1 clinical trial evaluating HM15912 and Placebo for Pharmacology. Completed, enrolled 40 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPharmacology
CountriesSouth Korea
Collaborators--

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedSep 3, 2019
Enrollment StartOct 8, 2019
Primary CompletionNov 10, 2020
Study CompletionMay 3, 2021
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 6.8 years ago

Interventions

HM15912drug

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).

Placebodrug

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).