Neuro-Degenerative DiseasePhase 1NCT06625710
Evaluation of the Safety, Tolerability and PK Characteristics of GV1001 in Healthy Subjects
A Phase 1 study testing GV1001 in people with Neuro-Degenerative Disease, run by GemVax & Kael at 1 site in South Korea.
Trial summary
The goal of this clinical trial is to assess the the safety, tolerability and pharmacokinetic characteristics after single and multiple administration of GV1001 in healthy subjects. Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuro-Degenerative Disease
- What is being tested?
- GV1001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Oct 2024to 25 Aug 2025
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- is healthy adults aged between 19 and 50 years at the time of screening. In Part B, only male participants will be included.
- [Extra Cohort Only] is healthy Caucasian aged between 19 and 50 years at the time of screening.
- weigh between 50 kg and 90 kg and have a body mass index (BMI) of 18.0 to 27.0.
- has no skin diseases or skin damage (including scars and tattoos) at the administration site and should not have any medical history that could affect pharmacokinetics (PK)
Who cannot join
- has clinically significant or history of liver, kidney, nervous system, respiratory system, endocrine, blood, tumor, cardiovascular, or mental disorders (such as mood disorders, obsessive-compulsive disorder, etc.);
- has a history of clinically significant hypersensitivity reactions;
- who showed the following results during the screening test:
- positive serum test results (Hepatitis B, C test, Human Immunodeficiency Virus (HIV), Syphilis test);
- [Part B only] testosterone levels outside the normal range (2.67-10.12 ng/ml);
- [Part B only] Leutinizing hormone (LH) outside the normal range (1.0 - 5.3 mlU/ml); [Part B only] Follicular stimulating hormone (FSH) outside the normal range (1.3 - 8.1 mlU/ml)
Show all 16Show fewer
- has a history of substance abuse or those who tested positive for illicit drugs in a urine drug screening.
- who have taken any prescription medications within 2 weeks prior to the planned first administration, or any over-the-counter (OTC) medications or health supplements within 1 week;
- who have taken barbiturate-inducing or inhibiting drugs within 1 month prior to the planned first administration;
- who have participated in another clinical trial or a bioequivalence study within the past 6 months;
- who have donated whole blood within the past 2 months, or have donated blood components within the past month, or have received a transfusion within the past month prior to planned first administration;
- who engage in continuous alcohol consumption (over 21 units/week = 10g of pure alcohol) or are unable to abstain from alcohol from 3 days prior to the expected first dosing until the last visit.
- who are unable to abstain from consuming grapefruit-containing foods or caffeine-containing foods from 3 days prior to the planned first administration of the investigational product (IP) until the post study visit (PSV);
- who have smoked more than 10 cigarettes per day in the past 3 months, or who cannot abstain from smoking during the clinical trial;
- who do not use medically acceptable methods of contraception during the clinical trial period;
- pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo Controlled, Dose-escalation Phase 1 Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics After Single and Multiple Administration of GV1001 in Healthy Subjects
The goal of this clinical trial is to assess the the safety, tolerability and pharmacokinetic characteristics after single and multiple administration of GV1001 in healthy subjects. The main questions it aims to answer are:
Safety and Tolerability of GV1001 in different dose scheme, and PK Characteristics of GV1001 in differenct dose scheme
Part A: single dose, 8 days clinical trial participation including one 3-day hospitalization
Part B \& Extra Cohort: Multiple dose, 42 days clinical trial participation (12 days treatment + 30 days safety follow-up) including two times of 3-day hospitalization.
Read the detailed description
This is a randomized, double-blind, placebo controlled, dose-escalation phase 1 clinical trial to evaluate the safety, tolerability and pharmacokinetic characteristics after single and multiple administration of GV1001 in healthy subjects.
The study is divided into Part A and Part B. Part A focuses on assessing the safety, tolerability, and pharmacokinetic characteristics following a single subcutaneous (SC) administration of the GV1001. Part B aims to evaluate the safety, tolerability and pharmacokinetic characteristics following multiple administrations of GV1001. The dose escalation between each dosage group and the transition from Part A to Part B will be determined by the Safety Review Committee (SRC), based on the safety and tolerability data obtained from the previous dose and Part A. The Safety Review Committee (SRC) is an independent committee that reviews safety data while maintaining blind.
An Extra Cohort to assess the safety, tolerability, and pharmacokinetic characteristics of GV1001 in Caucasians can be implemented sequentially after the safety review by the SRC for the 1.12 mg dose group in Part B has been completed.
Screening tests will be conducted within 4 weeks of IP administration to select participants deemed suitable for the clinical trial. In this process, informed consent will be obtained, and a screening number will be assigned to the participants.
Part A - Single Dose Participants deemed suitable for Part A will be admitted on Day -1. On Day 1 at 9 AM, after fasting, they will receive a single SC administration of GV1001 or a placebo. Following this, they will complete the scheduled assessments of the safety, tolerability and pharmacokinetic characteristics and be discharged on Day 3. An end-of-study visit will take place on Day 8 as an outpatient appointment. Dose escalation to the next dose group within Part A will be determined by the SRC's review.
Part B - Multiple Dose Participants deemed suitable for Part B will be admitted on Day -1. On Day 1 at 9 AM, after fasting, participants will receive a single SC administration of GV1001 or a placebo. Following this, they will complete the scheduled assessments of the safety, tolerability and pharmacokinetic characteristics and be discharged on Day 2. Subsequently, participants will receive subcutaneous administrations of GV1001 or placebo in a fasting state during four outpatient visits. At Day 11, participants will be admitted and will complete the scheduled assessments of the safety, tolerability, pharmacokinetic characteristics and the last administration of GV1001 (Day 12). Participants will be discharged on Day 13, and the end of study visit will take place on Day 42, which is 30 days after the last administration. Dose escalation to the next dose group within Part B will be determined by the SRC's review.
The total target number of participants is 56. In Part A, 16 participants will be recruited in two dose groups (2.24 mg and 4.48 mg), while in Part B, 32 participants will be recruited across four dose groups (0.56 mg, 1.12 mg, 2.24 mg, and 4.48 mg). An additional cohort consisting of 8 Caucasian participants is planned, which will be recruited after the completion of the 1.12 mg dose group in Part B. All dose groups will recruit participants at a ratio of 6:2 for the study drug to placebo. All dose escalation between dose groups and from Part A to Part B will be determined by the SRC's review and must be carried out sequentially.
- Conditions
- Neuro-Degenerative Disease
- Being tested
- GV1001, Placebo
- Keywords
- Pharmacokinetic Characeristics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GV1001Drug
Also called Tertomotide
Lyophilized peptide from hTERT
PlaceboDrug
Also called Normal saline
0.9 % Normal Saline
| Study group | Role | What they receive |
|---|---|---|
| Part A-1 | Experimental | GV1001 2.24 mg SAD or Placebo Receives: Drug: GV1001; Drug: Placebo |
| Part A-2 | Experimental | GV1001 4.48 mg SAD or Placebo Receives: Drug: GV1001; Drug: Placebo |
| Part B-1 | Experimental | Part B-1: GV1001 0.56 mg MAD (6 treatments for 2 weeks) Receives: Drug: GV1001; Drug: Placebo |
| Part B-2 | Experimental | GV1001 1.12 mg MAD or Placebo (6 treatments for 2 weeks ) Receives: Drug: GV1001; Drug: Placebo |
| Part B-3 | Experimental | GV1001 2.24 mg MAD or Placebo (6 treatments for 2 weeks) Receives: Drug: GV1001; Drug: Placebo |
| Part B-4 | Experimental | GV1001 4.48 mg MAD or Placebo (6 treatments for 2 weeks) Receives: Drug: GV1001; Drug: Placebo |
| Extra Cohort | Experimental | GV1001 1.12 mg MAD or Placebo (6 treatments for 2 weeks ), Caucasian Only Receives: Drug: GV1001; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of GV1001
To evaluate the safety and tolerability of GV1001 in healthy adults during both single and multiple administrations in different dose scheme.
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
- Number of participants with treatment-related 12-lead ECG abnormality
- Number of participants with treatment-related Physical examination abnormality
- Number of participants with treatment-related Local response evaluation abnormality
- Number of participants with treatment-related Laboratory test abnormality
Measured: 6 weeks
PK Characteristics of GV1001
To evaluate the pharmacokinetic characteristics of GV1001 in healthy adults during both single and multiple administrations in different dose scheme.
- Part A: Cmax, AUClast, AUCinf, Tmax, t1/2, CL/F, Vz/F
- Part B, Extra cohort: Cmax, Cmax,ss, AUCτ, AUCτ,ss, Tmax, Tmax,ss, t1/2, t1/2,ss, CL/F, CLss/F, Vz/F, Vz,ss/F, Peak-trough fluctuation, Accumulation ratio
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start8 Oct 2024
- Primary completion25 Aug 2025
- Study completion25 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuro-Degenerative DiseaseStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- There are two sequential arms plus one extra cohort: Part A: 2.24 mg and 4.48 mg Part B: 0.56 mg, 1.12 mg, 2.24 mg, and 4.48 mg Extra cohort: 1.12 mg, 8 Caucasian, after completion of dose group 1.12 in Part B. All dose groups will recruit participants at a ratio of 6:2 for the study drug to placebo. All dose escalation between dose groups and from Part A to Part B will be determined by the SRC's review and must be carried out sequentially.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- GemVax & Kael
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyung-Sang Yu, M.D., Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06625710
- Sponsor's protocol ID
- GV1001-PK-CL1-013
- Status last verified
- Nov 2025
- First submitted
- 24 Sep 2024
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Controlled, Dose-escalation Phase 1 Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics After Single and Multiple Administration of GV1001 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06625710
- Acronym / sponsor ID
- GV1001-PK-CL1-013
- Conditions
- Neuro-Degenerative Disease
- Keywords
- Pharmacokinetic Characeristics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- GemVax & KaelIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- 25 Aug 2025 (actual)
- Study completion
- 25 Aug 2025 (actual)
- First posted
- 3 Oct 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 goal of this clinical trial is to assess the the safety, tolerability and pharmacokinetic characteristics after single and multiple administration of GV1001 in healthy subjects. The main questions it aims to answer are:
Safety and Tolerability of GV1001 in different dose scheme, and PK Characteristics of GV1001 in differenct dose scheme
Part A: single dose, 8 days clinical trial participation including one 3-day hospitalization
Part B \& Extra Cohort: Multiple dose, 42 days clinical trial participation (12 days treatment + 30 days safety follow-up) including two times of 3-day hospitalization.
Detailed description
This is a randomized, double-blind, placebo controlled, dose-escalation phase 1 clinical trial to evaluate the safety, tolerability and pharmacokinetic characteristics after single and multiple administration of GV1001 in healthy subjects.
The study is divided into Part A and Part B. Part A focuses on assessing the safety, tolerability, and pharmacokinetic characteristics following a single subcutaneous (SC) administration of the GV1001. Part B aims to evaluate the safety, tolerability and pharmacokinetic characteristics following multiple administrations of GV1001. The dose escalation between each dosage group and the transition from Part A to Part B will be determined by the Safety Review Committee (SRC), based on the safety and tolerability data obtained from the previous dose and Part A. The Safety Review Committee (SRC) is an independent committee that reviews safety data while maintaining blind.
An Extra Cohort to assess the safety, tolerability, and pharmacokinetic characteristics of GV1001 in Caucasians can be implemented sequentially after the safety review by the SRC for the 1.12 mg dose group in Part B has been completed.
Screening tests will be conducted within 4 weeks of IP administration to select participants deemed suitable for the clinical trial. In this process, informed consent will be obtained, and a screening number will be assigned to the participants.
Part A - Single Dose Participants deemed suitable for Part A will be admitted on Day -1. On Day 1 at 9 AM, after fasting, they will receive a single SC administration of GV1001 or a placebo. Following this, they will complete the scheduled assessments of the safety, tolerability and pharmacokinetic characteristics and be discharged on Day 3. An end-of-study visit will take place on Day 8 as an outpatient appointment. Dose escalation to the next dose group within Part A will be determined by the SRC's review.
Part B - Multiple Dose Participants deemed suitable for Part B will be admitted on Day -1. On Day 1 at 9 AM, after fasting, participants will receive a single SC administration of GV1001 or a placebo. Following this, they will complete the scheduled assessments of the safety, tolerability and pharmacokinetic characteristics and be discharged on Day 2. Subsequently, participants will receive subcutaneous administrations of GV1001 or placebo in a fasting state during four outpatient visits. At Day 11, participants will be admitted and will complete the scheduled assessments of the safety, tolerability, pharmacokinetic characteristics and the last administration of GV1001 (Day 12). Participants will be discharged on Day 13, and the end of study visit will take place on Day 42, which is 30 days after the last administration. Dose escalation to the next dose group within Part B will be determined by the SRC's review.
The total target number of participants is 56. In Part A, 16 participants will be recruited in two dose groups (2.24 mg and 4.48 mg), while in Part B, 32 participants will be recruited across four dose groups (0.56 mg, 1.12 mg, 2.24 mg, and 4.48 mg). An additional cohort consisting of 8 Caucasian participants is planned, which will be recruited after the completion of the 1.12 mg dose group in Part B. All dose groups will recruit participants at a ratio of 6:2 for the study drug to placebo. All dose escalation between dose groups and from Part A to Part B will be determined by the SRC's review and must be carried out sequentially.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
- Model description
- There are two sequential arms plus one extra cohort: Part A: 2.24 mg and 4.48 mg Part B: 0.56 mg, 1.12 mg, 2.24 mg, and 4.48 mg Extra cohort: 1.12 mg, 8 Caucasian, after completion of dose group 1.12 in Part B. All dose groups will recruit participants at a ratio of 6:2 for the study drug to placebo. All dose escalation between dose groups and from Part A to Part B will be determined by the SRC's review and must be carried out sequentially.
| Arm | Type | Receives |
|---|---|---|
| Part A-1 | Experimental | Drug: GV1001, Drug: PlaceboGV1001 2.24 mg SAD or Placebo |
| Part A-2 | Experimental | Drug: GV1001, Drug: PlaceboGV1001 4.48 mg SAD or Placebo |
| Part B-1 | Experimental | Drug: GV1001, Drug: PlaceboPart B-1: GV1001 0.56 mg MAD (6 treatments for 2 weeks) |
| Part B-2 | Experimental | Drug: GV1001, Drug: PlaceboGV1001 1.12 mg MAD or Placebo (6 treatments for 2 weeks ) |
| Part B-3 | Experimental | Drug: GV1001, Drug: PlaceboGV1001 2.24 mg MAD or Placebo (6 treatments for 2 weeks) |
| Part B-4 | Experimental | Drug: GV1001, Drug: PlaceboGV1001 4.48 mg MAD or Placebo (6 treatments for 2 weeks) |
| Extra Cohort | Experimental | Drug: GV1001, Drug: PlaceboGV1001 1.12 mg MAD or Placebo (6 treatments for 2 weeks ), Caucasian Only |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- is healthy adults aged between 19 and 50 years at the time of screening. In Part B, only male participants will be included.
- [Extra Cohort Only] is healthy Caucasian aged between 19 and 50 years at the time of screening.
- weigh between 50 kg and 90 kg and have a body mass index (BMI) of 18.0 to 27.0.
- has no skin diseases or skin damage (including scars and tattoos) at the administration site and should not have any medical history that could affect pharmacokinetics (PK)
Key exclusion criteria (16 listed)
- has clinically significant or history of liver, kidney, nervous system, respiratory system, endocrine, blood, tumor, cardiovascular, or mental disorders (such as mood disorders, obsessive-compulsive disorder, etc.);
- has a history of clinically significant hypersensitivity reactions;
- who showed the following results during the screening test:
- has a history of substance abuse or those who tested positive for illicit drugs in a urine drug screening.
- who have taken any prescription medications within 2 weeks prior to the planned first administration, or any over-the-counter (OTC) medications or health supplements within 1 week;
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 |
|---|---|---|
| GV1001Also: TertomotideLyophilized peptide from hTERT | Drug | Extra Cohort, Part A-1, Part A-2, Part B-1, Part B-2, Part B-3, Part B-4 |
| PlaceboAlso: Normal saline0.9 % Normal Saline | Drug | Extra Cohort, Part A-1, Part A-2, Part B-1, Part B-2, Part B-3, Part B-4 |
Primary outcome
Safety and Tolerability of GV1001
Time frame: 6 weeks
To evaluate the safety and tolerability of GV1001 in healthy adults during both single and multiple administrations in different dose scheme. 1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 2. Number of participants with treatment-related 12-lead ECG abnormality 3. Number of participants with treatment-related Physical examination abnormality 4. Number of participants with treatment-related Local response evaluation abnormality 5. Number of participants with treatment-related Laboratory test abnormality
PK Characteristics of GV1001
Time frame: 2 weeks
To evaluate the pharmacokinetic characteristics of GV1001 in healthy adults during both single and multiple administrations in different dose scheme. 1. Part A: Cmax, AUClast, AUCinf, Tmax, t1/2, CL/F, Vz/F 2. Part B, Extra cohort: Cmax, Cmax,ss, AUCτ, AUCτ,ss, Tmax, Tmax,ss, t1/2, t1/2,ss, CL/F, CLss/F, Vz/F, Vz,ss/F, Peak-trough fluctuation, Accumulation ratio
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 19 Nov 2025.
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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.
Kyung-Sang Yu, M.D., Ph.D. principal investigator
Seoul National University Hospital
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 testing GV1001 in people with Neuro-Degenerative Disease, run by GemVax & Kael 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 16 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 19 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 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 of GV1001 (time frame: 6 weeks). The study lists 2 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 19 Nov 2025.