Autoimmune DiseasesPhase 1NCT04298749
Safety and Tolerability of GX-P1 in Healthy Male Volunteers
A Phase 1 study of Autoimmune Diseases, run by Genexine, Inc. at 1 site in South Korea.
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 Read more about this study
- Who is it for?
- Ages 19 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Autoimmune Diseases
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Aug 2020to 7 Jun 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
- Other clinically significant abnormalities which make subject unsuitable for inclusion this study judged by investigator
Trial locations and contacts
1 site in 1 country.
About this study
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
This study is a single-center, double-blind, placebo-controlled, phase I study with healthy male volunteers receiving ascending single dose of GX-P1
- Conditions
- Autoimmune Diseases
- Being tested
- GX-P1 or Placebo (dose level 1), GX-P1 or Placebo (dose level 2), GX-P1 or Placebo (dose level 3)
- Medical subject headings
- Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GX-P1 or Placebo (dose level 1)Drug
GX-P1 dose level 1 or placebo
GX-P1 or Placebo (dose level 2)Drug
GX-P1 dose level 2 or placebo
GX-P1 or Placebo (dose level 3)Drug
GX-P1 dose level 3 or placebo
| Study group | Role | What they receive |
|---|---|---|
| GX-P1 dose level 1 | Experimental | GX-P1 dose level 1 Receives: Drug: GX-P1 or Placebo (dose level 1) |
| GX-P1 dose level 2 | Experimental | GX-P1 dose level 2 Receives: Drug: GX-P1 or Placebo (dose level 2) |
| GX-P1 dose level 3 | Experimental | GX-P1 dose level 3 Receives: Drug: GX-P1 or Placebo (dose level 3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability as measured by AEs
Safety and tolerability will be assessed by monitoring AEs and performing physical/clinical examinations
Measured: up to 8 weeks
Secondary outcomes (6)
Cmax, Maximum observed concentration
Maximum observed concentration
Measured: up to 4 weeks
Tmax, Time to maximum observed concentration
Time to maximum observed concentration
Measured: up to 4 weeks
T1/2, Elimination half life of GX-P1
Elimination half life of GX-P1
Measured: 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
Measured: up to 4 weeks
Change in number of T cells
Change of T cell subsets
Measured: up to 4 weeks
Incidence of Treatment Emergent anti-drug antibody(ADA) formation
Treatment Emergent anti-drug antibody(ADA) formation
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start11 Aug 2020
- Primary completion7 Jun 2021
- Study completion7 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genexine, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298749
- Sponsor's protocol ID
- GX-P1-001
- Status last verified
- Jul 2021
- First submitted
- 28 Feb 2020
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04298749
- Acronym / sponsor ID
- GX-P1-001
- Conditions
- Autoimmune Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Genexine, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Aug 2020 (actual)
- Primary completion
- 7 Jun 2021 (actual)
- Study completion
- 7 Jun 2021 (actual)
- First posted
- 6 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GX-P1 dose level 1 | Experimental | Drug: GX-P1 or Placebo (dose level 1)GX-P1 dose level 1 |
| GX-P1 dose level 2 | Experimental | Drug: GX-P1 or Placebo (dose level 2)GX-P1 dose level 2 |
| GX-P1 dose level 3 | Experimental | Drug: GX-P1 or Placebo (dose level 3)GX-P1 dose level 3 |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GX-P1 or Placebo (dose level 1)GX-P1 dose level 1 or placebo | Drug | GX-P1 dose level 1 |
| GX-P1 or Placebo (dose level 2)GX-P1 dose level 2 or placebo | Drug | GX-P1 dose level 2 |
| GX-P1 or Placebo (dose level 3)GX-P1 dose level 3 or placebo | Drug | GX-P1 dose level 3 |
Primary outcome
Safety and tolerability as measured by AEs
Time frame: up to 8 weeks
Safety and tolerability will be assessed by monitoring AEs and performing physical/clinical examinations
6 secondary outcomes
Cmax, Maximum observed concentration
Time frame: up to 4 weeks
Tmax, Time to maximum observed concentration
Time frame: up to 4 weeks
T1/2, Elimination half life of GX-P1
Time frame: up to 4 weeks
AUC(0-inf), Area under the concentration-time curve from time zero extrapolated to infinite time
Time frame: up to 4 weeks
Change in number of T cells
Time frame: up to 4 weeks
Incidence of Treatment Emergent anti-drug antibody(ADA) formation
Time frame: up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Autoimmune Diseases, run by Genexine, Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability as measured by AEs (time frame: up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2021.