Ignite Creation Date:
2024-05-06 @ 3:24 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04620304
Status:
COMPLETED
Last Update Posted:
2023-04-24
First Post:
2020-10-22
Brief Title:
Study for Evaluation of the Safety Pharmacokinetics and Antiviral Activity of UB-421 Subcutaneous Formulation Administered in HIV-1 Infected Treatment Naive Patients
Sponsor:
United BioPharma
Organization:
United BioPharma
Study Overview
Official Title:
A Phase I Open-Label Multi-Dose Study for Evaluation of the Safety Pharmacokinetics and Antiviral Activity of UB-421 Subcutaneous Formulation Administered in HIV-1 Infected Treatment Naive Patients
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase I open-label dose-escalation study to investigate short-term safety pharmacokinetics and antiviral activity of UB-421 SC with 4 weekly doses in treatment naive HIV-1 infected patients Eligible n6 per dose cohort subjects will be sequentially enrolled into 3 escalating-dose cohorts to receive 4 weekly fixed doses of UB-421 SC at either 250 mg Cohort A 500 mg Cohort B or 700 mg Cohort C Subjects should be followed for safety for additional 4 weeks after the last UB-421 SC dosing In order to control viral load while minimizing confounding in safety assessment subjects can initiate standard anti-retroviral therapy ART two weeks after the last UB-421 SC dosing
Escalation to the next higher dose cohort will be determined based on dose limited toxicity DLT evaluation The dose escalation will be stopped if 26 subjects experience DLT or when clinical trial steering committee CTSC determines it is not suitable to escalate the dose level
In this study DLT is defined as any grade 3 AE occurred within 21 days from prior UB-421 SC dosing and is considered drug related
When there is any grade 3 AEs occurred within 21 days from prior UB-421 SC dosing in any subject out of the current dose cohort n6 the duty of the CTSC will be initiated The CTSC will be responsible for DLT evaluation The committee members will evaluate the safety data of all subjects in each cohort through baseline to at least 21 days following the last UB-421 SC dosing The administration of the next higher dose level at TV1 will be conducted after the committee grants the dose escalation However dose escalation will be proceeded if there is no grade 3 AE and upon agreement from all investigators without holding the steering committee meeting
Subjects will be assessed at Screening weekly during Treatment Period and Follow-up Period The assessment includes physical examination vital sign laboratory parameters HIV-1 viral load CD4 and CD8 T-cell counts Samples for the drug concentration measurement will be collected at weekly intervals throughout the study immediately before UB-421 SC dosing Additional intensive PK sampling will be scheduled during the first dosing interval from TV1 to TV2 at 1 3 6 24 48 72 and 96 hours post first UB-421 SC dosing for PK subgroup at least 3 subjects per dose cohort The immunogenicity of UB-421 SC will be monitored by measuring anti-UB-421 antibodies in pre-dose serum samples at day 0 and post-dose serum at day 14 28 35 42 and 49 Viral reservoir immunophenotyping and CD4 D1 receptor occupancy will also be explored
Subjects should discontinue from UB-421 SC treatment if they experience a sustained decrease from baseline in CD4 D2 T cell counts of 50 at two consecutive visits or drug-related AEs with severity grade 3 or 4 according to the Division of AIDS National Institute of Allergy and Infectious Diseases DAIDS AE grading
Escalation to the next higher dose cohort will be determined based on dose limited toxicity DLT evaluation The dose escalation will be stopped if 26 subjects experience DLT or when clinical trial steering committee CTSC determines it is not suitable to escalate the dose level
In this study DLT is defined as any grade 3 AE occurred within 21 days from prior UB-421 SC dosing and is considered drug related
When there is any grade 3 AEs occurred within 21 days from prior UB-421 SC dosing in any subject out of the current dose cohort n6 the duty of the CTSC will be initiated The CTSC will be responsible for DLT evaluation The committee members will evaluate the safety data of all subjects in each cohort through baseline to at least 21 days following the last UB-421 SC dosing The administration of the next higher dose level at TV1 will be conducted after the committee grants the dose escalation However dose escalation will be proceeded if there is no grade 3 AE and upon agreement from all investigators without holding the steering committee meeting
Subjects will be assessed at Screening weekly during Treatment Period and Follow-up Period The assessment includes physical examination vital sign laboratory parameters HIV-1 viral load CD4 and CD8 T-cell counts Samples for the drug concentration measurement will be collected at weekly intervals throughout the study immediately before UB-421 SC dosing Additional intensive PK sampling will be scheduled during the first dosing interval from TV1 to TV2 at 1 3 6 24 48 72 and 96 hours post first UB-421 SC dosing for PK subgroup at least 3 subjects per dose cohort The immunogenicity of UB-421 SC will be monitored by measuring anti-UB-421 antibodies in pre-dose serum samples at day 0 and post-dose serum at day 14 28 35 42 and 49 Viral reservoir immunophenotyping and CD4 D1 receptor occupancy will also be explored
Subjects should discontinue from UB-421 SC treatment if they experience a sustained decrease from baseline in CD4 D2 T cell counts of 50 at two consecutive visits or drug-related AEs with severity grade 3 or 4 according to the Division of AIDS National Institute of Allergy and Infectious Diseases DAIDS AE grading
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None