Ignite Creation Date:
2024-10-25 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06625710
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
Evaluation of the Safety Tolerability and PK Characteristics of GV1001 in Healthy Subjects
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 112 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 SRCs 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 SRCs review
The total target number of participants is 56 In Part A 16 participants will be recruited in two dose groups 224 mg and 448 mg while in Part B 32 participants will be recruited across four dose groups 056 mg 112 mg 224 mg and 448 mg An additional cohort consisting of 8 Caucasian participants is planned which will be recruited after the completion of the 112 mg dose group in Part B All dose groups will recruit participants at a ratio of 62 for the study drug to placebo All dose escalation between dose groups and from Part A to Part B will be determined by the SRCs review and must be carried out sequentially
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 112 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 SRCs 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 SRCs review
The total target number of participants is 56 In Part A 16 participants will be recruited in two dose groups 224 mg and 448 mg while in Part B 32 participants will be recruited across four dose groups 056 mg 112 mg 224 mg and 448 mg An additional cohort consisting of 8 Caucasian participants is planned which will be recruited after the completion of the 112 mg dose group in Part B All dose groups will recruit participants at a ratio of 62 for the study drug to placebo All dose escalation between dose groups and from Part A to Part B will be determined by the SRCs review and must be carried out sequentially
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None