Asan Medical Center
Seoul, South Korea
NCT Number: NCT04298749
This study is a single-center, double-blind, placebo-controlled, phase I study with healthy male volunteers receiving ascending single dose of GX-P1
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Notify Me19 year–45 year
Male
Interventional
Phase 1
Seoul, South Korea
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
GX-P1 dose level 1 or placebo
GX-P1 dose level 2 or placebo
GX-P1 dose level 3 or placebo
Time frame: up to 8 weeks
Safety and tolerability will be assessed by monitoring AEs and performing physical/clinical examinations
Time frame: up to 4 weeks
Maximum observed concentration
Time frame: up to 4 weeks
Time to maximum observed concentration
Time frame: up to 4 weeks
Elimination half life of GX-P1
Time frame: up to 4 weeks
Area under the concentration-time curve from time zero extrapolated to infinite time
Time frame: up to 4 weeks
Change of T cell subsets
Time frame: up to 8 weeks
Treatment Emergent anti-drug antibody(ADA) formation
Genexine, Inc.
Industry
A Randomized, Double Blind, Placebo-controlled, Dose-escalation Phase I Study to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GX-P1 After Single IV Infusion in Healthy Male Volunteers
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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