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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 59
- Locations
- 1
- Primary Endpoint
- Safety and Tolerability of GV1001
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
- •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)
Exclusion Criteria
- •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;
- •pregnant or breastfeeding women.
Arms & Interventions
Part B-3
GV1001 2.24 mg MAD or Placebo (6 treatments for 2 weeks)
Intervention: GV1001 (Drug)
Part B-3
GV1001 2.24 mg MAD or Placebo (6 treatments for 2 weeks)
Intervention: Placebo (Drug)
Part A-1
GV1001 2.24 mg SAD or Placebo
Intervention: GV1001 (Drug)
Part A-1
GV1001 2.24 mg SAD or Placebo
Intervention: Placebo (Drug)
Part A-2
GV1001 4.48 mg SAD or Placebo
Intervention: GV1001 (Drug)
Part A-2
GV1001 4.48 mg SAD or Placebo
Intervention: Placebo (Drug)
Part B-1
Part B-1: GV1001 0.56 mg MAD (6 treatments for 2 weeks)
Intervention: GV1001 (Drug)
Part B-1
Part B-1: GV1001 0.56 mg MAD (6 treatments for 2 weeks)
Intervention: Placebo (Drug)
Part B-2
GV1001 1.12 mg MAD or Placebo (6 treatments for 2 weeks )
Intervention: GV1001 (Drug)
Part B-2
GV1001 1.12 mg MAD or Placebo (6 treatments for 2 weeks )
Intervention: Placebo (Drug)
Part B-4
GV1001 4.48 mg MAD or Placebo (6 treatments for 2 weeks)
Intervention: GV1001 (Drug)
Part B-4
GV1001 4.48 mg MAD or Placebo (6 treatments for 2 weeks)
Intervention: Placebo (Drug)
Extra Cohort
GV1001 1.12 mg MAD or Placebo (6 treatments for 2 weeks ), Caucasian Only
Intervention: GV1001 (Drug)
Extra Cohort
GV1001 1.12 mg MAD or Placebo (6 treatments for 2 weeks ), Caucasian Only
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported