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Molar Potency Study of HM12470 in Healthy Subjects

NCT ID: NCT03330327

Last Updated: 2017-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-30

Study Completion Date

2017-08-17

Brief Summary

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

Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1

Intravenous (IV) infusion of HM12470

Group Type EXPERIMENTAL

HM12470

Intervention Type BIOLOGICAL

HM12470 is a long-acting insulin analogue

Part 2: Sequence 1

Intravenous (IV) infusion of HM12470

Group Type EXPERIMENTAL

HM12470

Intervention Type BIOLOGICAL

HM12470 is a long-acting insulin analogue

Part 2: Sequence 2

Intravenous (IV) infusion of HM12470

Group Type EXPERIMENTAL

HM12470

Intervention Type BIOLOGICAL

HM12470 is a long-acting insulin analogue

Interventions

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HM12470

HM12470 is a long-acting insulin analogue

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hanmi Investigative Site

Chula Vista, California, United States

Site Status

Countries

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United States

Other Identifiers

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HM-INS-115-102

Identifier Type: -

Identifier Source: org_study_id