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OpenTrials
Completed

NCT Number: NCT04076293

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 in Healthy Korean Subjects

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Key information

Conditions

Pharmacology

Age range

19 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Asan Medical Center

Seoul, 05505, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HM15912

Drug

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).

Placebo

Drug

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).

Primary outcomes

  1. Number of Participants With Treatment-emergent Adverse Events of HM15912

    Time frame: after single subcutaneous (SC) doses for 44 days

    Number of participants with any treatment-emergent adverse events related to study medication.

  2. Number of Participants With Significant Findings Observed for Hematology

    Time frame: after single subcutaneous (SC) doses for 44 days

Secondary outcomes

  1. Concentration Max Profile of HM15912

    Time frame: after single subcutaneous (SC) doses at day 1,2,3,4,5,6,7,10,17 and 30

    To assess the Concentration Max profile of HM15912 after single SC doses.

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Sep 3, 2019
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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