Ignite Creation Date:
2024-10-25 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06521931
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
A Study of PN20 for the Prevention of Chemotherapy-induced Thrombocytopenia in Lymphoma or Solid Tumor Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single-arm Dose Escalation Study to Evaluate the Safety Tolerability Pharmacokinetic Pharmacodynamics and Immunogenicity of PN20 for the Prevention of Chemotherapy-induced Thrombocytopenia in Patients With Lymphoma or Solid Tumor
Status:
RECRUITING
Status Verified Date:
2024-07
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 main aim of this clinical trial is to assess the safety and tolerability of PN20 in adult patients with chemotherapy-induced thrombocytopenia CID The main questions it aims to answer are
Is PN20 safe in these patients
Could these patients potentially benefit from PN20 prevention Participants will
Receive subcutaneous injections of PN20 according to weight on the first day of chemotherapy cycle within 1 hour before the administration of chemotherapy drugs
Visit the clinic on Day 1 D1 D2 D3 D4 D5 D8 D11 D13 D15 and D21 for assessment
Is PN20 safe in these patients
Could these patients potentially benefit from PN20 prevention Participants will
Receive subcutaneous injections of PN20 according to weight on the first day of chemotherapy cycle within 1 hour before the administration of chemotherapy drugs
Visit the clinic on Day 1 D1 D2 D3 D4 D5 D8 D11 D13 D15 and D21 for assessment
Detailed Description:
This is a multicenter single-arm open-label dose escalation study to evaluate the safety tolerability pharmacokinetic pharmacodynamics and immunogenicity of PN20 for the Prevention of Chemotherapy-induced Thrombocytopenia in Adult Patients With Lymphoma or Solid Tumor
This study was divided into two phase single-dose and multiple-dose After single-dose period 21 days if the subject meets the multiple-dose criteria he or she can enter the multiple-dose phase for the second cycle of PN20 prevention Subjects could receive a maximum of two cycles of PN20 prevention
This study was divided into two phase single-dose and multiple-dose After single-dose period 21 days if the subject meets the multiple-dose criteria he or she can enter the multiple-dose phase for the second cycle of PN20 prevention Subjects could receive a maximum of two cycles of PN20 prevention
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