NCT03330327

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
Last Updated

November 6, 2017

Status Verified

October 1, 2017

Enrollment Period

2.4 years

First QC Date

October 26, 2017

Last Update Submit

October 31, 2017

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

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

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

    1 month

Secondary Outcomes (2)

  • Cmax of HM12470

    1 month

  • AUC of HM12470

    1 month

Study Arms (3)

Part 1

EXPERIMENTAL

Intravenous (IV) infusion of HM12470

Biological: HM12470

Part 2: Sequence 1

EXPERIMENTAL

Intravenous (IV) infusion of HM12470

Biological: HM12470

Part 2: Sequence 2

EXPERIMENTAL

Intravenous (IV) infusion of HM12470

Biological: HM12470

Interventions

HM12470BIOLOGICAL

HM12470 is a long-acting insulin analogue

Part 1Part 2: Sequence 1Part 2: Sequence 2

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanmi Investigative Site

Chula Vista, California, 91911, United States

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2017

First Posted

November 6, 2017

Study Start

March 30, 2015

Primary Completion

August 17, 2017

Study Completion

August 17, 2017

Last Updated

November 6, 2017

Record last verified: 2017-10

Locations

US(1)