A Study of HM11260C in Healthy Male Subject

NCT01093729 | Completed Phase 1

• 1 other identifier: HM-EXC-101
• Study Type: interventional
• Target: 41
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Keywords

Exendin-4

Outcome Measures

Primary Outcomes (1)

• Safety

  Investigate Safety of HM10560A: Safety data, including physical examinations, laboratory evaluation, ECGs, vital signs, adverse events, and immunogenicity

  1, 2, 3, 4, 5, 7, 9, 16, 22, 30, 36, 43, 57, 84 Day

Study Arms (5)

Cohort1

EXPERIMENTAL

HM11260C 0.5mcg/kg or Placebo

Drug: HM11260C

Cohort2

EXPERIMENTAL

HM11260C 2mcg/kg or Placebo

Drug: HM11260C

Cohort3

EXPERIMENTAL

HM11260C 4mcg/kg or Placebo

Drug: HM11260C

Cohort4

EXPERIMENTAL

HM11260C 8mcg/kg or Placebo

Drug: HM11260C

Cohort5

EXPERIMENTAL

HM11260C 14mcg/kg or Placebo

Drug: HM11260C

Interventions

HM11260C DRUG

HM11260C 0.5mcg/kg or Placebo

Cohort1

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male volunteers, age range 20 to 45 years
• 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

You may not qualify if:

• Acute disease within 1 month prior to start of study drug administration
• Has previously disease which affect drug absorption, distribution, metabolism, excretion (e.g., inflammatory gastric disease, gastric or intestinal ulcer, hepatic disease, renal disease)
• History or presence of clinically significant and active cardiovascular, pulmonary, renal, endocrine, hematological, gastrointestinal, central nervous system, psychiatric disorder, autoimmune disease, or malignant tumor
• 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)
• Laboratory test results
• AST (sGOT) or ALT (sGPT) \> 1.25Xupper normal limit
• Total bilirubin \> 1.5Xupper normal limit
• Absolute Neutrophil Count \< 1500 mm2
• History or presence of clinically significant allergic disease (including mild allergic rhinitis and allergic dermatitis which is not necessary to medication)
• Prior exposure to products related to Exenatide
• Use of any prescription medication within 14 days prior to Day 1
• Use of any medication within 7 days prior to Day 1 (over-the-counter medication, herbal products, nutrient, vitamins)
• Subject who can't eat standard meal received by Korea University Anam Hospital
• 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
• Participation in another clinical study within 60 days prior to start of study drug administration

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Officials

• Hanmi Clinical

  Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2010
• First Posted: March 26, 2010
• Study Start: February 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: February 7, 2014

Record last verified: 2011-12