Ignite Creation Date:
2024-10-25 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06630494
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-04
Brief Title:
Phase I Study to Evaluate rhTPO in Healthy Caucasian Volunteers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single-center Single-arm Open-label Single-dose Phase I Clinical Study to Evaluate Pharmacokinetics Pharmacodynamics Safety and Tolerability of rhTPO in Healthy Caucasian Participants Approximately 22 Subjects Will be Enrolled
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:
This is a single-center single-arm open-label single-dose phase I clinical study to evaluate pharmacokinetics PK pharmacodynamics PD safety and tolerability of Recombinant Human Thrombopoietin for Injection rhTPO in healthy Caucasian participants Approximately 22 healthy Caucasian participants will be enrolled for this study
One dose level is planned in this study and participants will receive a single abdominal subcutaneous injection at a dose of 300 Ukg after entering the study
Participants will undergo screening admission baseline administration and follow-up observation period Participants will sign an informed consent form before any study procedures are performed During screening all participants will be screened for study eligibility within 28 days prior to administration Eligible participants will be admitted to the clinical study ward no later than one day prior to dosing D-1 Participants need to fast for at least 10 hours prior to dosing and 4 hours after dosing Single abdominal subcutaneous injection of the study drug will be given on D1 The administration and follow-up observation period will be 29 days D1D29 Participants may be discharged at D7 at the judgment of the investigator PK blood samples will be collected from D-1 to D14 tolerance and safety will be observed from D1 to D29 and blood samples for PD and ADA will be collected from screening to D29 After completion of relevant assessments on D29 participants will be considered as having completed this study
One dose level is planned in this study and participants will receive a single abdominal subcutaneous injection at a dose of 300 Ukg after entering the study
Participants will undergo screening admission baseline administration and follow-up observation period Participants will sign an informed consent form before any study procedures are performed During screening all participants will be screened for study eligibility within 28 days prior to administration Eligible participants will be admitted to the clinical study ward no later than one day prior to dosing D-1 Participants need to fast for at least 10 hours prior to dosing and 4 hours after dosing Single abdominal subcutaneous injection of the study drug will be given on D1 The administration and follow-up observation period will be 29 days D1D29 Participants may be discharged at D7 at the judgment of the investigator PK blood samples will be collected from D-1 to D14 tolerance and safety will be observed from D1 to D29 and blood samples for PD and ADA will be collected from screening to D29 After completion of relevant assessments on D29 participants will be considered as having completed this study
Detailed Description:
This is a single-center single-arm open-label single-dose phase I clinical study to evaluate pharmacokinetics pharmacodynamics safety and tolerability of Recombinant Human Thrombopoietin for Injection rhTPO in healthy Caucasian participants Approximately 22 healthy Caucasian participants will be enrolled for this study
One dose level is planned in this study and participants will receive a single abdominal subcutaneous injection at a dose of 300 Ukg after entering the study
Participants will undergo screening admission baseline administration and follow-up observation period Participants will sign an informed consent form before any study procedures are performed During screening all participants will be screened for study eligibility within 28 days prior to administration Eligible participants will be admitted to the clinical study ward no later than one day prior to dosing D-1 Participants need to fast for at least 10 hours prior to dosing and 4 hours after dosing Single abdominal subcutaneous injection of the study drug will be given on D1 The administration and follow-up observation period will be 29 days D1D29 Participants may be discharged at D7 at the judgment of the investigator PK blood samples will be collected from D-1 to D14 tolerance and safety will be observed from D1 to D29 and blood samples for PD and ADA will be collected from screening to D29 After completion of relevant assessments on D29 participants will be considered as having completed this study
One dose level is planned in this study and participants will receive a single abdominal subcutaneous injection at a dose of 300 Ukg after entering the study
Participants will undergo screening admission baseline administration and follow-up observation period Participants will sign an informed consent form before any study procedures are performed During screening all participants will be screened for study eligibility within 28 days prior to administration Eligible participants will be admitted to the clinical study ward no later than one day prior to dosing D-1 Participants need to fast for at least 10 hours prior to dosing and 4 hours after dosing Single abdominal subcutaneous injection of the study drug will be given on D1 The administration and follow-up observation period will be 29 days D1D29 Participants may be discharged at D7 at the judgment of the investigator PK blood samples will be collected from D-1 to D14 tolerance and safety will be observed from D1 to D29 and blood samples for PD and ADA will be collected from screening to D29 After completion of relevant assessments on D29 participants will be considered as having completed this study
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