A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM12470

Diabetes Mellitus Clinical Trial

Official title:

A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single Administration of HM12470 in Subjects With Type 1 (T1DM) and Type 2 Diabetes Mellitus (T2DM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02302443
• Other study ID #: HM-INS115-101
• Status: Completed
• Phase: Phase 1
• First received: November 19, 2014
• Last updated: November 7, 2017
• Start date: January 2015
• Est. completion date: May 2017

Study information

• Verified date: November 2017
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate safety, tolerability, pharmacokinetics (PK) ad pharmacodynamics (PD) of HM12470 after single injection in T1DM and T2DM patients.

Description:

This study is designed to evaluate safety, tolerability, PK and PD of HM12470 after single administration in subjects with T1DM and T2DM. In some cohorts for this study, the safety, tolerability, PK and PD of HM12470 will be compared with that of commercially available insulin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria for T1DM:

• T2DM more than 12 monthM

• Age =18 and =70 years

• Body mass index between 18.0 and 35.0 kg/m2 inclusive.

• Considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.

• Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal for >12 months. Males must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, the subject must be using an acceptable contraceptive method during and for during a period of 60 days after the last dose of Study Drug.

• Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject).

Inclusion Criteria for T2DM:

• T1DM more than 12 monthM

• Age =18 and =70 years

• Body mass index between 18.0 and 30.0 kg/m2 inclusive.

• Considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.

• Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal for >12 months. Males must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, the subject must be using an acceptable contraceptive method during and for during a period of 60 days after the last dose of Study Drug.

• Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject).

Exclusion Criteria

• A subject who has proliferative retinopathy or maculopathy, severe gastroparesis, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator

• Recurrent major hypoglycemia or hypoglycemic unawareness or recent ketoacidosis

• pregnant or lactating women

• participation in an investigational study within 30 days prior to dosing

• Clinically significant abnormal ECG at screening, as judged by the Investigator

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Biological:
• HM12470
Single dose subcutaneous administration ranging from a very low dose to high dose
• Active comparator
Single dose subcutaneous administration of active comparator

Locations

Country	Name	City	State
Korea, Republic of	Hanmi Pharmaceutical Company	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of treatment emergent adverse events		1 month
Secondary	Peak Plasma Concentration(Cmax) of HM12470 following a single dose	Pharmacokinetic properties of HM12470 following a single dose will be assessed in plasma using a validated assay	1 month
Secondary	Area under the concentration-time curve (AUC) of HM12470 following a single dose	Pharmacokinetic properties of HM12470 following a single dose will be assessed in plasma using a validated assay	1 month