Safety and Tolerability of GX-P1 in Healthy Male Volunteers

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

This study is a single-center, double-blind, placebo-controlled, phase I study with healthy male volunteers receiving ascending single dose of GX-P1

Study Overview

• Status: Completed
• Conditions: Autoimmune Diseases
• Intervention / Treatment: Drug: GX-P1 or Placebo (dose level 1); Drug: GX-P1 or Placebo (dose level 2); Drug: GX-P1 or Placebo (dose level 3)

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. 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
2. History of or current disease evidence including malignant tumor
3. History of allergy/hypersensitivity or ongoing allergy/hypersensitivity to any drug
4. Have participated in another clinical trial with investigational drug within 180 days prior to screening period
5. Positive for HCV antibody, HBsAg, or HIV antibody at screening period
6. Other clinically significant abnormalities which make subject unsuitable for inclusion this study judged by investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GX-P1 dose level 1	Drug: GX-P1 or Placebo (dose level 1); GX-P1 dose level 1 or placebo
Experimental: GX-P1 dose level 2	Drug: GX-P1 or Placebo (dose level 2); GX-P1 dose level 2 or placebo
Experimental: GX-P1 dose level 3	Drug: GX-P1 or Placebo (dose level 3); GX-P1 dose level 3 or placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability as measured by AEs	Safety and tolerability will be assessed by monitoring AEs and performing physical/clinical examinations	up to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax, Maximum observed concentration	Maximum observed concentration	up to 4 weeks
Tmax, Time to maximum observed concentration	Time to maximum observed concentration	up to 4 weeks
T1/2, Elimination half life of GX-P1	Elimination half life of GX-P1	up to 4 weeks
AUC(0-inf), Area under the concentration-time curve from time zero extrapolated to infinite time	Area under the concentration-time curve from time zero extrapolated to infinite time	up to 4 weeks
Change in number of T cells	Change of T cell subsets	up to 4 weeks
Incidence of Treatment Emergent anti-drug antibody(ADA) formation	Treatment Emergent anti-drug antibody(ADA) formation	up to 8 weeks

Collaborators and Investigators

• Sponsor: Genexine, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2020
• Primary Completion (Actual): June 7, 2021
• Study Completion (Actual): June 7, 2021

Study Registration Dates

• First Submitted: February 28, 2020
• First Submitted That Met QC Criteria: March 4, 2020
• First Posted (Actual): March 6, 2020

Study Record Updates

• Last Update Posted (Actual): July 27, 2021
• Last Update Submitted That Met QC Criteria: July 21, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases
• Other Study ID Numbers: GX-P1-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No