NCT04283695

To Investigate the Absorption, Metabolism, Excretion, Absolute Bioavailability, and Immunogenicity of GX-I7 in Healthy Volunteers

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

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

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

Detailed description

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 To show ABA and Mass balance of GX-I7

Conditions

• Leukopenia

Interventions

Type	Name	Description
DRUG	GX-I7 or [14C] GX-I7	IM GX-I7 or IV/IM microdose of GX-I7

Timeline

• Start date: 2019-07-03
• Primary completion: 2019-08-30
• Completion: 2020-05-01
• First posted: 2020-02-25
• Last updated: 2020-02-25

Locations

1 site across 1 country: South Korea