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Completed

NCT Number: NCT03374241

A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15211(Efocipegtrutide)

Single ascending dose of HM15211 in healthy obese subjects.

Completed

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hanmi Investigative Site

Chula Vista, California, 91911, United States

About this study

A First-in-human study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics after single ascending dose of HM15211 in healthy obese subjects.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Female subjects must be non-pregnant and non-lactating

Exclusion criteria

  • Participation in an investigational study within 30 days prior to dosing

Treatment and study plan

HM15211 or Placebo

Biological

Long-acting tri-agonist

Primary outcomes

  1. Number of Participants With Adverse Events

    Time frame: 1 month

    An adverse event is any undesirable and unintended medical event occurring to a subject in a clinical study, whether or not related to the investigational products

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single Ascending Dose of HM15211(Efocipegtrutide) in Healthy Obese Subjects

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 15, 2017
Registry last updated
Feb 6, 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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