Safety and Tolerability of GX-P1 in Healthy Male Volunteers

Phase 1

Completed

• Conditions: Autoimmune Diseases
• Interventions: Drug: GX-P1 or Placebo (dose level 2); Drug: GX-P1 or Placebo (dose level 3); Drug: GX-P1 or Placebo (dose level 1)

• Registration Number: NCT04298749
• Lead Sponsor: Genexine, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-28
• Study First Submitted QC: 2020-03-04
• Study First Posted: 2020-03-06
• Study Start: 2020-08-11
• Primary Completion: 2021-06-07
• Study Completion: 2021-06-07
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-21
• Last Update Posted: 2021-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GX-P1 dose level 2	GX-P1 or Placebo (dose level 2)	GX-P1 dose level 2
GX-P1 dose level 3	GX-P1 or Placebo (dose level 3)	GX-P1 dose level 3
GX-P1 dose level 1	GX-P1 or Placebo (dose level 1)	GX-P1 dose level 1

Primary Outcome Measures

Name	Time	Method
Safety and tolerability as measured by AEs	up to 8 weeks	Safety and tolerability will be assessed by monitoring AEs and performing physical/clinical examinations

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of