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OpenTrials
Completed

NCT Number: NCT04298749

Safety and Tolerability of GX-P1 in Healthy Male Volunteers

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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Key information

Age range

19 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Asan Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Capable of understanding and complying with the requirements of the study and have voluntarily signed the informed consent form (ICF)
  • Healthy male volunteers aged 19-45 years within screening periods
  • Body weight of 50-90 kg, and body mass index (BMI) of 18.0-30.0 kg/m2
  • Healthy subjects as determined by medical history, physical examination vital signs, ECG and clinical laboratory testing

Exclusion criteria

  • Any clinical significant pancreatic, hepatic, renal, gastrointestinal, cardiovascular, respiratory, hematological, central nervous system disease or other significant diseases which might influence either the safety of the subject or the absorption, metabolism or excretion of the active agent under investigation
  • History of or current disease evidence including malignant tumor
  • History of allergy/hypersensitivity or ongoing allergy/hypersensitivity to any drug
  • Have participated in another clinical trial with investigational drug within 180 days prior to screening period
  • Positive for HCV antibody, HBsAg, or HIV antibody at screening period
  • Other clinically significant abnormalities which make subject unsuitable for inclusion this study judged by investigator

Treatment and study plan

GX-P1 or Placebo (dose level 1)

Drug

GX-P1 dose level 1 or placebo

GX-P1 or Placebo (dose level 2)

Drug

GX-P1 dose level 2 or placebo

GX-P1 or Placebo (dose level 3)

Drug

GX-P1 dose level 3 or placebo

Primary outcomes

  1. Safety and tolerability as measured by AEs

    Time frame: up to 8 weeks

    Safety and tolerability will be assessed by monitoring AEs and performing physical/clinical examinations

Secondary outcomes

  1. Cmax, Maximum observed concentration

    Time frame: up to 4 weeks

    Maximum observed concentration

  2. Tmax, Time to maximum observed concentration

    Time frame: up to 4 weeks

    Time to maximum observed concentration

  3. T1/2, Elimination half life of GX-P1

    Time frame: up to 4 weeks

    Elimination half life of GX-P1

  4. AUC(0-inf), Area under the concentration-time curve from time zero extrapolated to infinite time

    Time frame: up to 4 weeks

    Area under the concentration-time curve from time zero extrapolated to infinite time

  5. Change in number of T cells

    Time frame: up to 4 weeks

    Change of T cell subsets

  6. Incidence of Treatment Emergent anti-drug antibody(ADA) formation

    Time frame: up to 8 weeks

    Treatment Emergent anti-drug antibody(ADA) formation

Sponsors and collaborators

Lead sponsor

Genexine, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 6, 2020
Registry last updated
Jul 27, 2021

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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