Evaluation of the Safety, Tolerability and PK Characteristics of GV1001 in Healthy Subjects

NCT06625710 | Completed Phase 1

• 1 other identifier: GV1001-PK-CL1-013
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Neuro-Degenerative Disease

Keywords

Pharmacokinetic Characeristics

Outcome Measures

Primary Outcomes (2)

• 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. 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

  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. 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

  2 weeks

Study Arms (7)

Part A-1

EXPERIMENTAL

GV1001 2.24 mg SAD or Placebo

Drug: GV1001; Drug: Placebo

Part A-2

EXPERIMENTAL

GV1001 4.48 mg SAD or Placebo

Drug: GV1001; Drug: Placebo

Part B-1

EXPERIMENTAL

Part B-1: GV1001 0.56 mg MAD (6 treatments for 2 weeks)

Drug: GV1001; Drug: Placebo

Part B-2

EXPERIMENTAL

GV1001 1.12 mg MAD or Placebo (6 treatments for 2 weeks )

Drug: GV1001; Drug: Placebo

Part B-3

EXPERIMENTAL

GV1001 2.24 mg MAD or Placebo (6 treatments for 2 weeks)

Drug: GV1001; Drug: Placebo

Part B-4

EXPERIMENTAL

GV1001 4.48 mg MAD or Placebo (6 treatments for 2 weeks)

Drug: GV1001; Drug: Placebo

Extra Cohort

EXPERIMENTAL

GV1001 1.12 mg MAD or Placebo (6 treatments for 2 weeks ), Caucasian Only

Drug: GV1001; Drug: Placebo

Interventions

GV1001 DRUG

Lyophilized peptide from hTERT

Also known as: Tertomotide

Extra Cohort; Part A-1; Part A-2; Part B-1; Part B-2; Part B-3; Part B-4

Placebo DRUG

0.9 % Normal Saline

Also known as: Normal saline

Extra Cohort; Part A-1; Part A-2; Part B-1; Part B-2; Part B-3; Part B-4

Eligibility Criteria

• Age: 19 Years - 50 Years
• Gender Eligibility Details: Part B and Extra Cohort only recruit healthy male volunteers
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)
• 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;

Sponsors & Collaborators

• GemVax & Kael: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

GV1001 peptide; Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Kyung-Sang Yu, M.D., Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: October 3, 2024
• Study Start: October 8, 2024
• Primary Completion: August 25, 2025
• Study Completion: August 25, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

KR (1)