NCT03330314

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Oct 2017

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

October 24, 2017

Completed
2 days 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
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2018

Completed
Last Updated

August 12, 2020

Status Verified

August 1, 2020

Enrollment Period

4 months

First QC Date

October 26, 2017

Last Update Submit

August 11, 2020

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

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

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

    1 month

Secondary Outcomes (2)

  • Cmax of HM12460A

    1 month

  • AUC of HM12460A

    1 month

Study Arms (4)

Part 1

EXPERIMENTAL

Intravenous (IV) infusion

Biological: HM12460A

Part 2: Cohort A

EXPERIMENTAL

Intravenous (IV) infusion (Dose A)

Biological: HM12460A

Part 2: Cohort B

EXPERIMENTAL

Intravenous (IV) infusion (Dose B)

Biological: HM12460A

Part 2: Cohort C

EXPERIMENTAL

Intravenous (IV) infusion (Dose C)

Biological: HM12460A

Interventions

HM12460ABIOLOGICAL

HM12460A is a long-acting insulin

Part 1Part 2: Cohort APart 2: Cohort BPart 2: Cohort C

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:

  • 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

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

October 24, 2017

Primary Completion

February 8, 2018

Study Completion

February 8, 2018

Last Updated

August 12, 2020

Record last verified: 2020-08

Locations

US(1)