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OpenTrials
Completed

NCT Number: NCT03330327

Molar Potency Study of HM12470 in Healthy Subjects

This is a phase 1 study to assess and compare molar potency of HM12470 and regular human insulin in healthy subjects.

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Key information

Conditions

Healthy Subjects

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

  • Participation in an investigational study within 30 days prior to dosing
  • Use of new prescription and non-prescription drugs within 3 weeks preceding the first dosing

Treatment and study plan

HM12470

Biological

HM12470 is a long-acting insulin analogue

Primary outcomes

  1. Blood glucose assessment of HM12470 and regular human insulin (RHI) over the entire dosing period

    Time frame: 1 month

    • Comparison of HM12470 to RHI based on blood glucose profile generated by intravenous infusion

Secondary outcomes

  1. Cmax of HM12470

    Time frame: 1 month

    • Maximum concentration of HM12470 over the entire dosing period

  2. AUC of HM12470

    Time frame: 1 month

    • Area Under the Curve of HM12470 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 HM12470 and Regular Human Insulin in Healthy Subjects

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 6, 2017
Registry last updated
Nov 6, 2017

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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