To Investigate the Absorption, Metabolism, Excretion, Absolute Bioavailability, and Immunogenicity of GX-I7 in Healthy Volunteers
NCT04283695 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2020-02-25
Summary
A Phase 1, open-labeled, single-dose, one-sequence, one-period, 3-part study to investigate the absorption, metabolism, excretion, absolute bioavailability, and immunogenicity of GX-I7 in healthy volunteers
Conditions
Interventions
- DRUG
-
GX-I7 or [14C] GX-I7
IM GX-I7 or IV/IM microdose of GX-I7
Sponsors & Collaborators
-
Seoul National University Hospital
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 19 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-07-03
- Primary Completion
- 2019-08-30
- Completion
- 2020-05-01
Countries
- South Korea
Study Locations
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