A Study of HM11260C in Healthy Male Subject

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: HM11260C

Study type: Interventional

Funder types: Industry

Identifiers

NCT01093729

HM-EXC-101

Details and patient eligibility

About

Study Design: Randomized, double-blind, placebo-controlled, escalating single-dose design. Five ascending dose cohorts are planned.

Full description

Primary Objective: To assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single subcutaneous dose of HM11260C in healthy male subjects.

Enrollment: 41 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Healthy male volunteers, age range 20 to 45 years
2. Weight>50 and < 90kg, Body mass index of >18 and <27 Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study

Exclusion Criteria

1. Acute disease within 1 month prior to start of study drug administration

2. Has previously disease which affect drug absorption, distribution, metabolism, excretion (e.g., inflammatory gastric disease, gastric or intestinal ulcer, hepatic disease, renal disease)

3. History or presence of clinically significant and active cardiovascular, pulmonary, renal, endocrine, hematological, gastrointestinal, central nervous system, psychiatric disorder, autoimmune disease, or malignant tumor

4. Has unsuitable clinical test results through the medical checkup, within 35 days prior to start of administration of study drug (medical history, physical examination, ECG, laboratory test)

5. Laboratory test results

   1. AST (sGOT) or ALT (sGPT) > 1.25Xupper normal limit
   2. Total bilirubin > 1.5Xupper normal limit
   3. Absolute Neutrophil Count < 1500 mm2

6. History or presence of clinically significant allergic disease (including mild allergic rhinitis and allergic dermatitis which is not necessary to medication)

7. Prior exposure to products related to Exenatide

8. Use of any prescription medication within 14 days prior to Day 1

9. Use of any medication within 7 days prior to Day 1 (over-the-counter medication, herbal products, nutrient, vitamins)

10. Subject who can't eat standard meal received by Korea University Anam Hospital

11. Donor of whole blood for transfusion within 60 days prior to start of study drug administration or donor of apheresis within 20 days or Receiver of blood transfusion within 1 month

12. Participation in another clinical study within 60 days prior to start of study drug administration

13. Taking Caffein(> 5cups/ day) or alcohol abuse (> 30g/ day) or excessive smoker(> 10 Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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41 participants in 5 patient groups

Cohort1

Experimental group

Description:

HM11260C 0.5mcg/kg or Placebo

Treatment:

Drug: HM11260C

Drug: HM11260C

Drug: HM11260C

Drug: HM11260C

Drug: HM11260C

Cohort2

Experimental group

Description:

HM11260C 2mcg/kg or Placebo

Treatment:

Drug: HM11260C

Drug: HM11260C

Drug: HM11260C

Drug: HM11260C

Drug: HM11260C

Cohort3

Experimental group

Description:

HM11260C 4mcg/kg or Placebo

Treatment:

Drug: HM11260C

Drug: HM11260C

Drug: HM11260C

Drug: HM11260C

Drug: HM11260C

Cohort4

Experimental group

Description:

HM11260C 8mcg/kg or Placebo

Treatment:

Drug: HM11260C

Drug: HM11260C

Drug: HM11260C

Drug: HM11260C

Drug: HM11260C

Cohort5

Experimental group

Description:

HM11260C 14mcg/kg or Placebo

Treatment:

Drug: HM11260C

Drug: HM11260C

Drug: HM11260C

Drug: HM11260C

Drug: HM11260C