Molar Potency Study of HM12470 in Healthy Subjects

An Open Label, Fixed-Sequence, Glucose Clamp Study to Compare Molar Potency of HM12470 and Regular Human Insulin in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03330327

Enrollment

Registered

2017-11-06

Start date

2015-03-30

Completion date

2017-08-17

Last updated

2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

Brief summary

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

Interventions

BIOLOGICALHM12470

HM12470 is a long-acting insulin analogue

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Blood glucose assessment of HM12470 and regular human insulin (RHI) over the entire dosing period	1 month	\- Comparison of HM12470 to RHI based on blood glucose profile generated by intravenous infusion

Secondary

Measure	Time frame	Description
Cmax of HM12470	1 month	\- Maximum concentration of HM12470 over the entire dosing period
AUC of HM12470	1 month	\- Area Under the Curve of HM12470 over the entire dosing period

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026