Safety and Tolerability of GX-P1 in Healthy Male Volunteers

• Sponsor: Genexine, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04298749
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 3
• Actual Duration (Months): 9.9
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Autoimmune Diseases	Drug: GX-P1 or Placebo (dose level 1); Drug: GX-P1 or Placebo (dose level 2); Drug: GX-P1 or Placebo (dose level 3)	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Aug 11, 2020
• Actual Primary Completion Date: Jun 7, 2021
• Actual Study Completion Date: Jun 7, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Cmax, Maximum observed concentration [up to 4 weeks]

   Maximum observed concentration

2. Tmax, Time to maximum observed concentration [up to 4 weeks]

   Time to maximum observed concentration

3. T1/2, Elimination half life of GX-P1 [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 [up to 4 weeks]

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

5. Change in number of T cells [up to 4 weeks]

   Change of T cell subsets

6. Incidence of Treatment Emergent anti-drug antibody(ADA) formation [up to 8 weeks]

   Treatment Emergent anti-drug antibody(ADA) formation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asan Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

• Genexine, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Genexine, Inc.
• ClinicalTrials.gov Identifier: NCT04298749
• Other Study ID Numbers: GX-P1-001
• First Posted: Mar 6, 2020
• Last Update Posted: Jul 27, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Autoimmune Diseases

Study Results

No Results Posted as of Jul 27, 2021