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

November 7, 2017 updated by: Hanmi Pharmaceutical Company Limited

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
Very low dose of HM12470 (single dose, subcutaneous injection)
Biological: HM12470
Single dose subcutaneous administration ranging from a very low dose to high dose
Experimental: Cohort 2
Low dose of HM12470 (single dose, subcutaneous injection)
Biological: HM12470
Single dose subcutaneous administration ranging from a very low dose to high dose
Experimental: Cohort 3
Intermediate dose of HM12470 (single dose, subcutaneous injection)
Biological: HM12470
Single dose subcutaneous administration ranging from a very low dose to high dose
Experimental: Cohort 4
High dose of HM12470 (single dose, subcutaneous injection)
Biological: HM12470
Single dose subcutaneous administration ranging from a very low dose to high dose
Experimental: Cohort 5
Active comparator and a selected dose of HM12470 (single dose, subcutaneous injection)
Biological: HM12470
Single dose subcutaneous administration ranging from a very low dose to high dose
Biological: Active comparator
Single dose subcutaneous administration of active comparator
Experimental: Cohort 6
Active comparator and a selected dose of HM12470 (single dose, subcutaneous injection)
Biological: HM12470
Single dose subcutaneous administration ranging from a very low dose to high dose
Biological: Active comparator
Single dose subcutaneous administration of active comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of treatment emergent adverse events
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak Plasma Concentration(Cmax) of HM12470 following a single dose
Time Frame: 1 month
Pharmacokinetic properties of HM12470 following a single dose will be assessed in plasma using a validated assay
1 month
Area under the concentration-time curve (AUC) of HM12470 following a single dose
Time Frame: 1 month
Pharmacokinetic properties of HM12470 following a single dose will be assessed in plasma using a validated assay
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanmi Pharmaceutical Company Limited

Investigators

  • Study Director: Hanmi Pharmaceuticals Hanmi Pharmaceuticals, Hanmi pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

November 19, 2014

First Submitted That Met QC Criteria

November 24, 2014

First Posted (Estimate)

November 27, 2014

Study Record Updates

Last Update Posted (Actual)

November 8, 2017

Last Update Submitted That Met QC Criteria

November 7, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM-INS115-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus

Clinical Trials on HM12470

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe