← Trials/Trial dossier/NCT01093729

CompletedPhase 1

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

Assets

Efpeglenatide / Exenatide

Listed sites

0

Recruiting sites

Enrollment

41

actual

Study population

Healthy volunteers

Key I/E criteria

BMI 18-27MaleHealthy volunteers

Primary endpoint

Safety

Identifiers

Registered as

NCT IDNCT01093729
Org study IDHM-EXC-101

Timeline

Milestones

Study first posted2010-03-26estimated
Last update posted2014-02-07estimated
Study start2010-02 (month precision)
Primary completion2010-10actual (month precision)
Study completion2010-10actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age20 Years
Maximum age45 Years
SexMale
Healthy volunteersAccepted

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

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Safety

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

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.