Safety and Tolerability of GX-P1 in Healthy Male Volunteers

Autoimmune Diseases Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04298749
• Other study ID #: GX-P1-001
• Status: Completed
• Phase: Phase 1
• Start date: August 11, 2020
• Est. completion date: June 7, 2021

Study information

• Verified date: July 2021
• Source: Genexine, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 7, 2021
• Est. primary completion date: June 7, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Diseases

Intervention

Drug:
• GX-P1 or Placebo (dose level 1)
GX-P1 dose level 1 or placebo
• GX-P1 or Placebo (dose level 2)
GX-P1 dose level 2 or placebo
• GX-P1 or Placebo (dose level 3)
GX-P1 dose level 3 or placebo

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Genexine, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cmax, Maximum observed concentration	Maximum observed concentration	up to 4 weeks
Secondary	Tmax, Time to maximum observed concentration	Time to maximum observed concentration	up to 4 weeks
Secondary	T1/2, Elimination half life of GX-P1	Elimination half life of GX-P1	up to 4 weeks
Secondary	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
Secondary	Change in number of T cells	Change of T cell subsets	up to 4 weeks
Secondary	Incidence of Treatment Emergent anti-drug antibody(ADA) formation	Treatment Emergent anti-drug antibody(ADA) formation	up to 8 weeks