Phase I Study GX-G3 in Healthy Subjects
NCT01951027 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 53
Last updated 2015-01-29
Summary
pharmacokinetics/pharmacodynamics of GX-G3 after single subcutaneous administration in healthy male subjects.
Conditions
- Healthy
Interventions
- DRUG
-
GX-G3 12.5 μg/kg or Placebo
Single SC injection
- DRUG
-
GX-G3 25 μg/kg or Placebo
Single SC injection
- DRUG
-
GX-G3 50 μg/kg or Placebo
Single SC injection
- DRUG
-
GX-G3 100 μg/kg or Placebo
Single SC injection
Sponsors & Collaborators
-
Genexine, Inc.
lead INDUSTRY
Principal Investigators
-
Sang-In Yang, Ph.D · Genexine, Inc, Clinical development Department
-
Jae Woo Kim, M.D. · CHUNGNAM NATIONAL UNIVERSITY HOSPITAL Clinical Research Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SCREENING
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2013-09-30
- Primary Completion
- 2014-07-31
- Completion
- 2014-12-31
Countries
- South Korea
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