Molar Potency Study of HM12460A in Healthy Subjects

An Open Label, Fixed-Sequence, Glucose Clamp Study to Compare Molar Potency of HM12460A and Insulin Glargine in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03330314

Enrollment

Registered

2017-11-06

Start date

2017-10-24

Completion date

2018-02-08

Last updated

2020-08-12

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

Conditions

Healthy Volunteers

Brief summary

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

Interventions

BIOLOGICALHM12460A

HM12460A is a long-acting insulin

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

* 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

Design outcomes

Primary

Measure	Time frame	Description
Blood glucose assessment of HM12460A and insulin glargine over the entire dosing period	1 month	\- Comparison of HM12460A to insulin glargine based on blood glucose profile generated by intravenous infusion

Secondary

Measure	Time frame	Description
Cmax of HM12460A	1 month	\- Maximum concentration of HM12460A over the entire dosing period
AUC of HM12460A	1 month	\- Area Under the Curve of HM12460A over the entire dosing period

Countries

United States

Outcome results

None listed

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