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OpenTrials
Completed

NCT Number: NCT03330314

Molar Potency Study of HM12460A in Healthy Subjects

This is a phase 1 study to assess and compare molar potency of HM12460A and glargine in healthy subjects.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hanmi Investigative Site

Chula Vista, California, 91911, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Females must be non-pregnant and non-lactating
  • Males must be surgically sterile or using an acceptable contraceptive method

Exclusion criteria

  • History of any major surgery within 6 months prior to screening
  • Use of any new prescription or non-prescription drug in the last 30 days

Treatment and study plan

HM12460A

Biological

HM12460A is a long-acting insulin

Primary outcomes

  1. Blood glucose assessment of HM12460A and insulin glargine over the entire dosing period

    Time frame: 1 month

    • Comparison of HM12460A to insulin glargine based on blood glucose profile generated by intravenous infusion

Secondary outcomes

  1. Cmax of HM12460A

    Time frame: 1 month

    • Maximum concentration of HM12460A over the entire dosing period

  2. AUC of HM12460A

    Time frame: 1 month

    • Area Under the Curve of HM12460A over the entire dosing period

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

An Open Label, Fixed-Sequence, Glucose Clamp Study to Compare Molar Potency of HM12460A and Insulin Glargine in Healthy Subjects

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 6, 2017
Registry last updated
Aug 12, 2020

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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