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
1 other identifier
interventional
24
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2020
CompletedFirst Posted
Study publicly available on registry
March 6, 2020
CompletedStudy Start
First participant enrolled
August 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 7, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 7, 2021
CompletedJuly 27, 2021
July 1, 2021
10 months
February 28, 2020
July 21, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Cmax, Maximum observed concentration
up to 4 weeks
Tmax, Time to maximum observed concentration
up to 4 weeks
T1/2, 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
up to 4 weeks
Change in number of T cells
up to 4 weeks
- +1 more secondary outcomes
Study Arms (3)
GX-P1 dose level 1
EXPERIMENTALGX-P1 dose level 1
GX-P1 dose level 2
EXPERIMENTALGX-P1 dose level 2
GX-P1 dose level 3
EXPERIMENTALGX-P1 dose level 3
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genexine, Inc.lead
Study Sites (1)
Asan Medical Center
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2020
First Posted
March 6, 2020
Study Start
August 11, 2020
Primary Completion
June 7, 2021
Study Completion
June 7, 2021
Last Updated
July 27, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share