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

NCT02302443 | Completed Phase 1

• 1 other identifier: HM-INS115-101
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of treatment emergent adverse events

  1 month

Secondary Outcomes (2)

• Peak Plasma Concentration(Cmax) of HM12470 following a single dose

  1 month

• Area under the concentration-time curve (AUC) of HM12470 following a single dose

  1 month

Study Arms (6)

Cohort 1

EXPERIMENTAL

Very low dose of HM12470 (single dose, subcutaneous injection)

Biological: HM12470

Cohort 2

EXPERIMENTAL

Low dose of HM12470 (single dose, subcutaneous injection)

Biological: HM12470

Cohort 3

EXPERIMENTAL

Intermediate dose of HM12470 (single dose, subcutaneous injection)

Biological: HM12470

Cohort 4

EXPERIMENTAL

High dose of HM12470 (single dose, subcutaneous injection)

Biological: HM12470

Cohort 5

EXPERIMENTAL

Active comparator and a selected dose of HM12470 (single dose, subcutaneous injection)

Biological: HM12470; Biological: Active comparator

Cohort 6

EXPERIMENTAL

Active comparator and a selected dose of HM12470 (single dose, subcutaneous injection)

Biological: HM12470; Biological: Active comparator

Interventions

HM12470 BIOLOGICAL

Single dose subcutaneous administration ranging from a very low dose to high dose

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6

Active comparator BIOLOGICAL

Single dose subcutaneous administration of active comparator

Cohort 5; Cohort 6

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

Hanmi Pharmaceutical Company

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Hanmi Pharmaceuticals Hanmi Pharmaceuticals

  Hanmi Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2014
• First Posted: November 27, 2014
• Study Start: January 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: November 8, 2017

Record last verified: 2017-11

Locations

KR (1)