Human PapillomavirusPhase 1NCT03144934
Safety and Tolerability of GX-I7 in HPV-infected Female Volunteers
A Phase 1 study testing GX-I7 in people with Human Papillomavirus, run by Genexine, Inc. at 4 sites in South Korea.
Trial summary
This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety and tolerability of GX-I7 in HPV-infected female volunteers Read more about this study
- Who is it for?
- Ages 19 to 45 years, women only
- Conditions the study is for
- Human Papillomavirus
- What is being tested?
- GX-I7
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 16 Feb 2017to 22 Mar 2018
- 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
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Subject willing and able to give informed consent
- Must be ≥19 and ≤45 years diagnosed with HPV infection in two tests within screening periods or have history of HPV infection within 6 months and diagnosed with HPV infection in one test within screening periods
- No clinical abnormality from ECG test
- Must agree to use appropriate contraceptive methods (ie, condoms, cervical cap in conjunction with spermicide, sterilization, and intra uterine device) during the study and for 3 months after the last dose of study drug.
Who cannot join
- Subject with HSIL or more severe HPV infection
- History of a known or suspected hypersensitivity, shock, or past history to the investigational drug or to similar drugs
- Malignant tumor within 5 years other than successfully treated skin cancer that is not melanoma
- Active infection or history of infection that required intravenous injection of antibiotics 4 weeks prior to the first administration of the investigational drug
- Female subject unwilling to stop breastfeeding or pregnancy
- Positive result from serology examination for human immunodeficiency virus (HIV)
Show all 11Show fewer
- Major surgery within 3 months other than access surgery
- Mental disorder or other central nervous system disorder determined that the study evaluation cannot be conducted
- Participation in any clinical study within 30 days
- History of alcohol or drug abuse within 6 months prior to the screening
- Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Chungnam National University Hospital
Daejeon, 35015
Yonsei University Health System, Severance Hospital
Seoul, 03722
Hallym University Medical Center-Kangnam
Seoul, 07441
Korea University Guro Hospital
Seoul, 08308
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of GX-I7 in HPV-infected Female Volunteers
This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety and tolerability of GX-I7 in HPV-infected female volunteers
Read the detailed description
The subjects who are adequately eligible to attend this clinical trial via screening will be assigned to four cohorts (five if necessary) and administered a single dose of GX-I7 solution or placebo drug for intravaginal injection at the visit 3 (Day0) and 7 (Day28). After completing scheduled tests at the visit 6 (Day 14), safety-related data of each cohort will be evaluated by Independent Safety Monitoring Committee (SMC). Dose escalation will proceed under the principal investigator, medical monitor, and the sponsor's mutual approval, referring to SMC's evaluation.
- Conditions
- Human Papillomavirus
- Being tested
- GX-I7, Placebo
- Keywords
- HPV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GX-I7Drug
Also called IL-7-hyFc
Interleukin-7 (IL-7) is T cell growth factor that can be used for treating lymphopenia patients. GX-I7 is a protein drug recombining human IL-7 and hybrid Fc (hyFc). HyFc made by Genexine is composed of hinge-CH2 region of Immunoglobulin D (IgD) and CH2-CH3 region of Immunoglobulin G4 (IgG4). The recombined region is not exposed and each region's characteristics can reduce immunogenicity and improve the efficacy of drug. Consequently, it will be able to treat the patients with lymphopenia in effective ways.
PlaceboDrug
Also called GX-I7 vehicle (formulation buffer)
This is the placebo of GX-I7 described above.
| Study group | Role | What they receive |
|---|---|---|
| Administraion of investigational product | Experimental | * 0.25mg, 1mg, 3mg, 6mg, or 9mg (optional) of GX-I7
* 6 subjects per each cohort
* twice administration with 4-week intervals Receives: Drug: GX-I7 |
| Administraion of placebo | Placebo comparator | * GX-I7 vehicle (formulation buffer)
* 2 subjects per each cohort
* twice administration with 4-week intervals Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to evaluate the safety of GX-I7 compared to placebo.
Local and systemic adverse events will be assessed by Department of AIDS (Table for Grading the Severity of Adult and Pediatric Adverse Events, 2004) and Toxicity Grading Scale for Healthy Volunteers Enrolled in Preventive Vaccine Clinical Trials, respectively. Also, vital signs (blood pressure, heart rate, and body temperature), physical examination, laboratory tests, upper abdomen ultrasound, immunogenicity test, and concentration of the investigational drug in blood sample will be assessed throughout the screening and study period.
Measured: 12 weeks
Secondary outcomes (1)
Type of Humanpapillo Virus (HPV) Persistent Infection of Human Papilloma Virus (HPV)
Perform liquid-based cytology after each injections
Measured: at week 0 (Day 0) and week 4 (Day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start16 Feb 2017
- Primary completion22 Mar 2018
- Study completion22 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human PapillomavirusStudies 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genexine, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jae Kwan Lee, MD, PhD, Principal investigator, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03144934
- Sponsor's protocol ID
- GX-I7M-HPV-002
- Status last verified
- Oct 2018
- First submitted
- 18 Apr 2017
- Last updated
- 23 Oct 2018
- 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 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of GX-I7 in HPV-infected Female Volunteers
- ClinicalTrials.gov ID
- NCT03144934
- Acronym / sponsor ID
- GX-I7M-HPV-002
- Conditions
- Human Papillomavirus
- Keywords
- HPV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Genexine, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Feb 2017 (actual)
- Primary completion
- 22 Mar 2018 (actual)
- Study completion
- 22 Mar 2018 (actual)
- First posted
- 9 May 2017 (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 is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety and tolerability of GX-I7 in HPV-infected female volunteers
Detailed description
The subjects who are adequately eligible to attend this clinical trial via screening will be assigned to four cohorts (five if necessary) and administered a single dose of GX-I7 solution or placebo drug for intravaginal injection at the visit 3 (Day0) and 7 (Day28). After completing scheduled tests at the visit 6 (Day 14), safety-related data of each cohort will be evaluated by Independent Safety Monitoring Committee (SMC). Dose escalation will proceed under the principal investigator, medical monitor, and the sponsor's mutual approval, referring to SMC's evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Administraion of investigational product | Experimental | Drug: GX-I7* 0.25mg, 1mg, 3mg, 6mg, or 9mg (optional) of GX-I7 * 6 subjects per each cohort * twice administration with 4-week intervals |
| Administraion of placebo | Placebo comparator | Drug: Placebo* GX-I7 vehicle (formulation buffer) * 2 subjects per each cohort * twice administration with 4-week intervals |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subject willing and able to give informed consent
- Must be ≥19 and ≤45 years diagnosed with HPV infection in two tests within screening periods or have history of HPV infection within 6 months and diagnosed with HPV infection in one test within screening periods
- No clinical abnormality from ECG test
- Must agree to use appropriate contraceptive methods (ie, condoms, cervical cap in conjunction with spermicide, sterilization, and intra uterine device) during the study and for 3 months after the last dose of study drug.
Key exclusion criteria (11 listed)
- Subject with HSIL or more severe HPV infection
- History of a known or suspected hypersensitivity, shock, or past history to the investigational drug or to similar drugs
- Malignant tumor within 5 years other than successfully treated skin cancer that is not melanoma
- Active infection or history of infection that required intravenous injection of antibiotics 4 weeks prior to the first administration of the investigational drug
- Female subject unwilling to stop breastfeeding or pregnancy
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-I7Also: IL-7-hyFcInterleukin-7 (IL-7) is T cell growth factor that can be used for treating lymphopenia patients. GX-I7 is a protein drug recombining human IL-7 and hybrid Fc (hyFc). HyFc made by Genexine is composed of hinge-CH2 region of Immunoglobulin D (IgD) and CH2-CH3 region of Immunoglobulin G4 (IgG4). The recombined region is not exposed and each region's characteristics can reduce immunogenicity and improve the efficacy of drug. Consequently, it will be able to treat the patients with lymphopenia in effective ways. | Drug | Administraion of investigational product |
| PlaceboAlso: GX-I7 vehicle (formulation buffer)This is the placebo of GX-I7 described above. | Drug | Administraion of placebo |
Primary outcome
The primary objective of this study is to evaluate the safety of GX-I7 compared to placebo.
Time frame: 12 weeks
Local and systemic adverse events will be assessed by Department of AIDS (Table for Grading the Severity of Adult and Pediatric Adverse Events, 2004) and Toxicity Grading Scale for Healthy Volunteers Enrolled in Preventive Vaccine Clinical Trials, respectively. Also, vital signs (blood pressure, heart rate, and body temperature), physical examination, laboratory tests, upper abdomen ultrasound, immunogenicity test, and concentration of the investigational drug in blood sample will be assessed throughout the screening and study period.
1 secondary outcome
Type of Humanpapillo Virus (HPV) Persistent Infection of Human Papilloma Virus (HPV)
Time frame: at week 0 (Day 0) and week 4 (Day 28)
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 23 Oct 2018.
- Individual participant dataSharing planned: No
Related trials for Human Papillomavirus
Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
RecruitingPhase 2
A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
Human Papilloma Virus (HPV), High-risk Human Papillomavirus Infection
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
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.
Jae Kwan Lee, MD, PhD principal investigator
Korea University Guro Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GX-I7 in people with Human Papillomavirus, run by Genexine, Inc. at 4 sites 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 11 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 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. Some participants in this study may receive a placebo. 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?
The primary objective of this study is to evaluate the safety of GX-I7 compared to placebo. (time frame: 12 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 23 Oct 2018.