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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
Lead sponsor
Assets
Efpeglenatide / Exenatide
Listed sites
0
Recruiting sites
—
Enrollment
41
actual
Study population
Healthy volunteers
Key I/E criteria
•BMI 18-27•Male•Healthy volunteers
Primary endpoint
•Safety
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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 endpointSafety
Time frame:1, 2, 3, 4, 5, 7, 9, 16, 22, 30, 36, 43, 57, 84 Day
descriptive
Provenance
Sources
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.