A Study of HM11260C in Healthy Male Subject

A Dose Block-randomized, Double-blind, Single Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of HM11260C After Subcutaneous Administration in Healthy Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01093729

Enrollment

Registered

2010-03-26

Start date

2010-02-28

Completion date

2010-10-31

Last updated

2014-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Exendin-4

Brief summary

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

Detailed description

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

Interventions

DRUGHM11260C

HM11260C 0.5mcg/kg or Placebo

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Safety	1, 2, 3, 4, 5, 7, 9, 16, 22, 30, 36, 43, 57, 84 Day	Investigate Safety of HM10560A: Safety data, including physical examinations, laboratory evaluation, ECGs, vital signs, adverse events, and immunogenicity

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026