Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06560489
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-08-15
Brief Title:
Pharmacokinetics and Efficacy of Multiple Dosing of LP-98 for Injection in HIV-infected Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Trial of Safety Pharmacodynamics and Pharmacokinetic Characteristics of Multiple Subcutaneous Injections of LP-98 in Primary Treatment of HIV-infected Patients
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
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:
A Randomized Double-Blind Parallel-Group Exploratory Clinical Study to Evaluate the Safety Pharmacodynamic Effects and Pharmacokinetic Characteristics of Multiple Subcutaneous Injections of LP-98 in Treatment-Naive HIV-Infected Individuals
Detailed Description:
This is a randomized double-blind parallelize-designed multicenter exploratory clinical study to evaluate the safety PD and PK profile of multiple subcutaneous injections of LP-98 in HIV-infected individuals who have not received antiviral therapy
This study consisted of 4 cohorts with 10 subjects in each group who were randomly assigned to receive LP-98 treatment of 125 mg 25 mg 5 mg and 10 mg The method of administration was subcutaneous injection and the interval of administration was 14 days a total of 4 doses
The study included screening period D-28D-1 treatment period D1-D57 and follow-up period D58D71
This study consisted of 4 cohorts with 10 subjects in each group who were randomly assigned to receive LP-98 treatment of 125 mg 25 mg 5 mg and 10 mg The method of administration was subcutaneous injection and the interval of administration was 14 days a total of 4 doses
The study included screening period D-28D-1 treatment period D1-D57 and follow-up period D58D71
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