Progressive Supranuclear PalsyPhase 2NCT06235775
Administration of GV1001 for the Treatment of Progressive Supranuclear Palsy Who Completed Study GV1001-PSP-CL2-011
A Phase 2 study testing GV1001 1.12mg in people with Progressive Supranuclear Palsy, run by GemVax & Kael at 5 sites in South Korea.
Trial summary
The study will be conducted by the Sponsor to evaluate Twelve-months Long-Term Safety and Efficacy of GV1001 (1.12 mg) administered subcutaneously as a treatment for Progressive Supranuclear Palsy(PSP). Read more about this study
- Who is it for?
- Ages 41 to 85 years
- Conditions the study is for
- Progressive Supranuclear Palsy
- What is being tested?
- GV1001 1.12mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 12 Dec 2023to 1 Sep 2025
- Phase
- Phase 2
- 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 41 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A person who has been registered in the GV1001-PSP-CL2-011 clinical trial and has completed administration by Week 24
- A patient who accompanied all visits with the subject for the scheduled visit of this clinical trial, has a guardian who can supervise the subject's compliance with the examination and examination procedures conducted at the time of the visit, and provides information on the subject's indications, and whose guardian has agreed in writing to participate in the clinical trial (except where it is unnecessary to accompany the guardian at the discretion of the investigator)
- Patient and/or representative of the patient who has voluntarily agreed in writing to participate in this clinical trial
Who cannot join
- Patients deemed unsuitable by the investigator to participate in this extension study
- Pregnant or male subjects who do not consent to contraception by medically approved methods (surgical infertility, intrauterine contraceptive devices, fallopian tube ligature, double blocking (combined use of male condoms, female condoms, cervical caps, contraceptive diaphragm and sponges) and 90 days after clinical trial participation However, women who have undergone menopause or surgical infertility procedures (such as vasectomy and difficult conception on both sides) before participating in clinical trials can participate without consent to contraception.
- Pregnant women or breastfeeding women
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Seoul National University Bundang Hospital
Seongnam-si
Kyung Hee University Hospital
Seoul
Samsung Medical Center
Seoul
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul
Seoul National University Hospital
Seoul
About this study
Official title: Twelve-months Extension Study to Explore the Long-Term Safety and Efficacy of Subcutaneous Administration of GV1001 1.12 mg/Day in Patients With Progressive Supranuclear Palsy Who Completed Study GV1001-PSP-CL2-011
The study will be conducted by the Sponsor to evaluate Twelve-months Long-Term Safety and Efficacy of GV1001 (1.12 mg) administered subcutaneously as a treatment for Progressive Supranuclear Palsy(PSP). In 75 patients diagnosed with PSP Richardson(PSP-RS) or PSP-Parkinsonism (PSP-P) who Completed Study GV1001-PSP-CL2-011.
Read the detailed description
In GV1001-PSP-CL2-011 study, subjects who were in the trial group (Study Group 1(GV1001 0.56 mg/day), Study Group 2(GV1001 1.12 mg/day) is alternately administered High-dose test drug(GV1001 1.12 mg/day) and placebo once a week from Ex-Visit 1(Visit 16, Week 26) to Ex-Visit 5(Visit 20, Week 30) and High-dose test drugs(GV1001 1.12 mg/day) are administered from Ex-Visit 6 (Visit 21, Week 32) to Ex-Visit 26(Visit 41, Week 72) every two weeks.
In the GV1001-PSP-CL2-011 study, subjects who were in the placebo group are administered placebo at Ex-Visit 1 (Visit16, Week26), the first visit of the extension study, and Ex-Visit 2 (Visit17, Week27) to Ex-Visit 5 (Visit 20, Week 30), High-dose test drugs(GV1001 1.12 mg/day) are administered once a week and High-dose test drugs (GV1001 1.12 mg/day) are administered from Ex-Visit 6 (Visit 21, Week 32) to Ex-Visit 26(Visit 41, Week 72) every two weeks.
- Conditions
- Progressive Supranuclear Palsy
- Being tested
- GV1001 Placebo, GV1001 1.12mg
- Keywords
- Progressive Supranuclear Palsy GV1001
- Medical subject headings
- Supranuclear Palsy, Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GV1001 PlaceboDrug
Also called Normal saline
0.9% normal saline
GV1001 1.12mgDrug
Also called Tertomotide 1.68mg
Lyophilized peptide from hTERT
| Study group | Role | What they receive |
|---|---|---|
| GV1001 1.12 mg | Experimental | In GV1001-PSP-CL2-011 study, subjects who were in the trial group (Study Group 1(GV1001 0.56 mg/day), Study Group 2(GV1001 1.12 mg/day) is alternately administered High-dose test drug(GV1001 1.12 mg/day) and placebo once a week from Ex-Visit 1(Visit 16, Week 26) to Ex-Visit 5(Visit 20, Week 30) and High-dose test drugs(GV1001 1.12 mg/day) are administered from Ex-Visit 6 (Visit 21, Week 32) to Ex-Visit 26(Visit 41, Week 72) every two weeks.
In the GV1001-PSP-CL2-011 study, subjects who were in the placebo group are administered placebo at Ex-Visit 1 (Visit16, Week26), the first visit of the extension study, and Ex-Visit 2 (Visit17, Week27) to Ex-Visit 5 (Visit 20, Week 30), High-dose test drugs(GV1001 1.12 mg/day) are administered once a week and High-dose test drugs (GV1001 1.12 mg/day) are administered from Ex-Visit 6 (Visit 21, Week 32) to Ex-Visit 26(Visit 41, Week 72) every two weeks. Receives: Drug: GV1001 Placebo; Drug: GV1001 1.12mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event
Adverse Event
Measured: 12 months
Change in Hematological tests WBC(10^3/µl)
WBC(10^3/µl)
For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Measured: 12 months
Change in Hematological tests RBC(10^6/µl)
RBC(10^6/µl)
For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Measured: 12 months
Change in Hematological tests Hemoglobin(g/dL)
Hemoglobin(g/dL)
For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Measured: 12 months
Change in Hematological tests Hematocrit(%)
Hematocrit(%)
For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Measured: 12 months
Change in Hematological tests Platelets count(10^3/µl)
Platelets count(10^3/µl)
For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Measured: 12 months
Change in Hematological tests WBC differential count (Neutrophils(%))
WBC differential count (Neutrophils(%)
For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Measured: 12 months
Change in Hematological tests WBC differential count( Lymphocytes(%))
Lymphocytes(%)
For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Measured: 12 months
Change in Hematological tests WBC differential count( Monocytes(%))
Monocytes(%)
For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Measured: 12 months
Change in Hematological tests WBC differential count(Eosinophils(%))
Eosinophils(%)
For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Measured: 12 months
Change in Hematological tests WBC differential count(Basophils(%))
Basophils(%)
For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Measured: 12 months
Change in Hematochemical tests BUN(mg/dL)
BUN(mg/dL)
For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Measured: 12 months
Change in Hematochemical tests Creatinine(mg/dL)
Creatinine(mg/dL)
For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Measured: 12 months
Change in Hematochemical tests Uric acid(mg/dL)
Uric acid(mg/dL)
For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Measured: 12 months
Change in Hematochemical tests Total bilirubin(mg/dL)
Total bilirubin(mg/dL)
For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Measured: 12 months
Change in Hematochemical tests Albumin(g/dL)
Albumin(g/dL)
For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Measured: 12 months
Change in Hematochemical tests Total Protein(g/dL)
Total Protein(g/dL)
For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Measured: 12 months
Change in Hematochemical tests ALT(U/L)
ALT(U/L)
For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Measured: 12 months
Change in Hematochemical tests AST(U/L)
AST(U/L)
For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Measured: 12 months
Change in Hematochemical tests γ-GTP(U/L)
γ-GTP(U/L)
For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Measured: 12 months
Change in Hematochemical tests Alkaline phosphatase(U/L)
Alkaline phosphatase(U/L)
For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Measured: 12 months
Change in Hematochemical tests Glucose(mg/dL)
Glucose(mg/dL)
For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Measured: 12 months
Change in Hematochemical tests Total Cholesterol(mg/dL)
Total Cholesterol(mg/dL)
For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Measured: 12 months
Change in urine tests Protein-Albumin(mg/dL)
Protein-Albumin(mg/dL)
For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Measured: 12 months
Change in urine tests Glucose(mg/dL)
Glucose(mg/dL)
For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Measured: 12 months
Change in urine tests Ketones(mg/dL)
Ketones(mg/dL)
For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Measured: 12 months
Change in urine tests WBC(HPF)
WBC(HPF)
For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Measured: 12 months
Change in urine tests Blood-RBC(HPF)
Blood-RBC(HPF)
For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Measured: 12 months
Blood Pressure (mmHG)
Change in Blood Pressure (mmHG)
Measured: 12 months
Pulse rate(beats per min)
Change in Pulse rate(beats per min)
Measured: 12 months
Respiratory rate(breaths per min)
Change in Respiratory rate(breaths per min)
Measured: 12 months
temperature(℃)
Change in temperature(℃)
Measured: 12 months
EKG
EKG result(normal or abnormal)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start12 Dec 2023
- Primary completion1 Sep 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Supranuclear PalsyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- GemVax & Kael
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sang Jae Kim, Study chair, GemVax & Kael
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06235775
- Sponsor's protocol ID
- GV1001-PSP-CL2-011-E
- Status last verified
- Nov 2025
- First submitted
- 11 Dec 2023
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Twelve-months Extension Study to Explore the Long-Term Safety and Efficacy of Subcutaneous Administration of GV1001 1.12 mg/Day in Patients With Progressive Supranuclear Palsy Who Completed Study GV1001-PSP-CL2-011
- ClinicalTrials.gov ID
- NCT06235775
- Acronym / sponsor ID
- GV1001-PSP-CL2-011-E
- Conditions
- Progressive Supranuclear Palsy
- Keywords
- Progressive Supranuclear Palsy GV1001
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- GemVax & KaelIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 1 Feb 2024 (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.
The study will be conducted by the Sponsor to evaluate Twelve-months Long-Term Safety and Efficacy of GV1001 (1.12 mg) administered subcutaneously as a treatment for Progressive Supranuclear Palsy(PSP). In 75 patients diagnosed with PSP Richardson(PSP-RS) or PSP-Parkinsonism (PSP-P) who Completed Study GV1001-PSP-CL2-011.
Detailed description
In GV1001-PSP-CL2-011 study, subjects who were in the trial group (Study Group 1(GV1001 0.56 mg/day), Study Group 2(GV1001 1.12 mg/day) is alternately administered High-dose test drug(GV1001 1.12 mg/day) and placebo once a week from Ex-Visit 1(Visit 16, Week 26) to Ex-Visit 5(Visit 20, Week 30) and High-dose test drugs(GV1001 1.12 mg/day) are administered from Ex-Visit 6 (Visit 21, Week 32) to Ex-Visit 26(Visit 41, Week 72) every two weeks.
In the GV1001-PSP-CL2-011 study, subjects who were in the placebo group are administered placebo at Ex-Visit 1 (Visit16, Week26), the first visit of the extension study, and Ex-Visit 2 (Visit17, Week27) to Ex-Visit 5 (Visit 20, Week 30), High-dose test drugs(GV1001 1.12 mg/day) are administered once a week and High-dose test drugs (GV1001 1.12 mg/day) are administered from Ex-Visit 6 (Visit 21, Week 32) to Ex-Visit 26(Visit 41, Week 72) every two weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GV1001 1.12 mg | Experimental | Drug: GV1001 Placebo, Drug: GV1001 1.12mgIn GV1001-PSP-CL2-011 study, subjects who were in the trial group (Study Group 1(GV1001 0.56 mg/day), Study Group 2(GV1001 1.12 mg/day) is alternately administered High-dose test drug(GV1001 1.12 mg/day) and placebo once a week from Ex-Visit 1(Visit 16, Week 26) to Ex-Visit 5(Visit 20, Week 30) and High-dose test drugs(GV1001 1.12 mg/day) are administered from Ex-Visit 6 (Visit 21, Week 32) to Ex-Visit 26(Visit 41, Week 72) every two weeks. In the GV1001-PSP-CL2-011 study, subjects who were in the placebo group are administered placebo at Ex-Visit 1 (Visit16, Week26), the first visit of the extension study, and Ex-Visit 2 (Visit17, Week27) to Ex-Visit 5 (Visit 20, Week 30), High-dose test drugs(GV1001 1.12 mg/day) are administered once a week and High-dose test drugs (GV1001 1.12 mg/day) are administered from Ex-Visit 6 (Visit 21, Week 32) to Ex-Visit 26(Visit 41, Week 72) every two weeks. |
Who may qualify
- Ages
- 41 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A person who has been registered in the GV1001-PSP-CL2-011 clinical trial and has completed administration by Week 24
- A patient who accompanied all visits with the subject for the scheduled visit of this clinical trial, has a guardian who can supervise the subject's compliance with the examination and examination procedures conducted at the time of the visit, and provides information on the subject's indications, and whose guardian has agreed in writing to participate in the clinical trial (except where it is unnecessary to accompany the guardian at the discretion of the investigator)
- Patient and/or representative of the patient who has voluntarily agreed in writing to participate in this clinical trial
Key exclusion criteria (3 listed)
- Patients deemed unsuitable by the investigator to participate in this extension study
- Pregnant or male subjects who do not consent to contraception by medically approved methods (surgical infertility, intrauterine contraceptive devices, fallopian tube ligature, double blocking (combined use of male condoms, female condoms, cervical caps, contraceptive diaphragm and sponges) and 90 days after clinical trial participation However, women who have undergone menopause or surgical infertility procedures (such as vasectomy and difficult conception on both sides) before participating in clinical trials can participate without consent to contraception.
- Pregnant women or breastfeeding women
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 |
|---|---|---|
| GV1001 PlaceboAlso: Normal saline0.9% normal saline | Drug | GV1001 1.12 mg |
| GV1001 1.12mgAlso: Tertomotide 1.68mgLyophilized peptide from hTERT | Drug | GV1001 1.12 mg |
Primary outcome
Adverse Event
Time frame: 12 months
Adverse Event
Change in Hematological tests WBC(10^3/µl)
Time frame: 12 months
WBC(10^3/µl) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Change in Hematological tests RBC(10^6/µl)
Time frame: 12 months
RBC(10^6/µl) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Change in Hematological tests Hemoglobin(g/dL)
Time frame: 12 months
Hemoglobin(g/dL) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Change in Hematological tests Hematocrit(%)
Time frame: 12 months
Hematocrit(%) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Change in Hematological tests Platelets count(10^3/µl)
Time frame: 12 months
Platelets count(10^3/µl) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Change in Hematological tests WBC differential count (Neutrophils(%))
Time frame: 12 months
WBC differential count (Neutrophils(%) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Change in Hematological tests WBC differential count( Lymphocytes(%))
Time frame: 12 months
Lymphocytes(%) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Change in Hematological tests WBC differential count( Monocytes(%))
Time frame: 12 months
Monocytes(%) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Change in Hematological tests WBC differential count(Eosinophils(%))
Time frame: 12 months
Eosinophils(%) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Change in Hematological tests WBC differential count(Basophils(%))
Time frame: 12 months
Basophils(%) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Change in Hematochemical tests BUN(mg/dL)
Time frame: 12 months
BUN(mg/dL) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Change in Hematochemical tests Creatinine(mg/dL)
Time frame: 12 months
Creatinine(mg/dL) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Change in Hematochemical tests Uric acid(mg/dL)
Time frame: 12 months
Uric acid(mg/dL) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Change in Hematochemical tests Total bilirubin(mg/dL)
Time frame: 12 months
Total bilirubin(mg/dL) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Change in Hematochemical tests Albumin(g/dL)
Time frame: 12 months
Albumin(g/dL) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Change in Hematochemical tests Total Protein(g/dL)
Time frame: 12 months
Total Protein(g/dL) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Change in Hematochemical tests ALT(U/L)
Time frame: 12 months
ALT(U/L) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Change in Hematochemical tests AST(U/L)
Time frame: 12 months
AST(U/L) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Change in Hematochemical tests γ-GTP(U/L)
Time frame: 12 months
γ-GTP(U/L) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Change in Hematochemical tests Alkaline phosphatase(U/L)
Time frame: 12 months
Alkaline phosphatase(U/L) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Change in Hematochemical tests Glucose(mg/dL)
Time frame: 12 months
Glucose(mg/dL) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Change in Hematochemical tests Total Cholesterol(mg/dL)
Time frame: 12 months
Total Cholesterol(mg/dL) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Change in urine tests Protein-Albumin(mg/dL)
Time frame: 12 months
Protein-Albumin(mg/dL) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Change in urine tests Glucose(mg/dL)
Time frame: 12 months
Glucose(mg/dL) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Change in urine tests Ketones(mg/dL)
Time frame: 12 months
Ketones(mg/dL) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Change in urine tests WBC(HPF)
Time frame: 12 months
WBC(HPF) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Change in urine tests Blood-RBC(HPF)
Time frame: 12 months
Blood-RBC(HPF) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group
Blood Pressure (mmHG)
Time frame: 12 months
Change in Blood Pressure (mmHG)
Pulse rate(beats per min)
Time frame: 12 months
Change in Pulse rate(beats per min)
Respiratory rate(breaths per min)
Time frame: 12 months
Change in Respiratory rate(breaths per min)
temperature(℃)
Time frame: 12 months
Change in temperature(℃)
EKG
Time frame: 12 months
EKG result(normal or abnormal)
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 21 Nov 2025.
- 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.
Sang Jae Kim study chair
GemVax & Kael
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GV1001 1.12mg in people with Progressive Supranuclear Palsy, run by GemVax & Kael at 5 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 3 inclusion and 3 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 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Adverse Event (time frame: 12 months). The study lists 33 primary outcomes in all. 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 21 Nov 2025.