Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06585891
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
Study of a Human Bispecific Antibody VRC-HIVMAB0121-00-AB CAP256J3LS Administered Intravenously or Subcutaneously to Healthy Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
VRC 617 A Phase 1 Open-Label Dose-Escalation Study to Evaluate Safety and Pharmacokinetics of a Human Bispecific Antibody VRC-HIVMAB0121-00-AB CAP256J3LS Administered Intravenously or Subcutaneously to Healthy Adults
Status:
RECRUITING
Status Verified Date:
2024-10-09
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:
Background
HIV human immunodeficiency virus is the virus that causes AIDS acquired immunodeficiency syndrome Researchers want to find new ways to treat or prevent HIV infection CAP256J3LS is a new product that uses antibodies Antibodies are naturally occurring proteins they target and disable disease-causing agents such as viruses This new product may be able to stop HIV infections
Objective
To test the safety of CAP256J3LS in healthy people
Eligibility
People aged 18 to 60 years in good general health
Design
CAP256J3LS can be administered in 2 ways 1 by a shot under the skin into the belly fat or 2 through a tube inserted into a vein in the arm Participants will be divided into 6 groups The study will open with the lowest dose of study product The dose groups are spaced out to allow the study team to look over the safety data in each group If there are no safety concerns in the lowest dose then the next higher dose groups will be enrolled This pattern will continue until all dose groups are enrolled Also some participants will receive only 1 dose others will receive 3 doses each spaced 12 weeks apart
Those who receive only 1 dose of the study drug will have 14 clinic visits over 6 months Those who get 3 doses will have 27 visits over 11 months Participants will provide blood samples at each visit Urine samples may also be needed
All participants will get a thermometer and a measuring tool They will measure any redness swelling or bruising they have at the injection site They will check their temperature every day for 7 days after receiving the study drug They will record their highest temperatures and any symptoms they have
HIV human immunodeficiency virus is the virus that causes AIDS acquired immunodeficiency syndrome Researchers want to find new ways to treat or prevent HIV infection CAP256J3LS is a new product that uses antibodies Antibodies are naturally occurring proteins they target and disable disease-causing agents such as viruses This new product may be able to stop HIV infections
Objective
To test the safety of CAP256J3LS in healthy people
Eligibility
People aged 18 to 60 years in good general health
Design
CAP256J3LS can be administered in 2 ways 1 by a shot under the skin into the belly fat or 2 through a tube inserted into a vein in the arm Participants will be divided into 6 groups The study will open with the lowest dose of study product The dose groups are spaced out to allow the study team to look over the safety data in each group If there are no safety concerns in the lowest dose then the next higher dose groups will be enrolled This pattern will continue until all dose groups are enrolled Also some participants will receive only 1 dose others will receive 3 doses each spaced 12 weeks apart
Those who receive only 1 dose of the study drug will have 14 clinic visits over 6 months Those who get 3 doses will have 27 visits over 11 months Participants will provide blood samples at each visit Urine samples may also be needed
All participants will get a thermometer and a measuring tool They will measure any redness swelling or bruising they have at the injection site They will check their temperature every day for 7 days after receiving the study drug They will record their highest temperatures and any symptoms they have
Detailed Description:
Design
This first-in-human Phase 1 open-label study will examine safety tolerability dose and pharmacokinetics PK of CAP256J3LS VRC-HIVMAB0121-00-AB in healthy adults in a dose-escalation design The primary hypothesis is that subcutaneous SC and intravenous IV administrations of CAP256J3LS will be safe and well-tolerated in healthy adults A secondary hypothesis is that CAP256J3LS will be detectable in human sera with a definable half-life
Study Products
The CAP256J3LS bispecific antibody bsAb targets the V2-apex and CD4-binding sites of the HIV-1 envelope It is composed of the J3 camelid nanobody linked to CAP256V2LS through a 15 amino acid linker arm attached to the N-terminus of the CAP256V2LS light chain The addition of the J3 nanobody adds a CD4-binding site directed neutralization functionality to the CAP256V2LS which targets the V2 region of the HIV Env trimer The bispecific antibody was developed by the VRCNIAIDNIH and is manufactured under cGMP regulations at the VRC Pilot Plant operated under contract by the Vaccine Clinical Materials Program VCMP Leidos Biomedical Research Inc Frederick MD
Participants
Healthy adults 18-60 years of age
Study Plan
This open-label study will include 6 groups to evaluate CAP256J3LS administered one time or by repeat dosing Enrollment will begin with the 5 mgkg dose groups and enrollment for subsequent dose groups will proceed after dose-escalation safety reviews Assessment of safety will include solicited reactogenicity and other adverse events clinical observations and monitoring of hematological and chemistry parameters at clinical visits throughout the study
This first-in-human Phase 1 open-label study will examine safety tolerability dose and pharmacokinetics PK of CAP256J3LS VRC-HIVMAB0121-00-AB in healthy adults in a dose-escalation design The primary hypothesis is that subcutaneous SC and intravenous IV administrations of CAP256J3LS will be safe and well-tolerated in healthy adults A secondary hypothesis is that CAP256J3LS will be detectable in human sera with a definable half-life
Study Products
The CAP256J3LS bispecific antibody bsAb targets the V2-apex and CD4-binding sites of the HIV-1 envelope It is composed of the J3 camelid nanobody linked to CAP256V2LS through a 15 amino acid linker arm attached to the N-terminus of the CAP256V2LS light chain The addition of the J3 nanobody adds a CD4-binding site directed neutralization functionality to the CAP256V2LS which targets the V2 region of the HIV Env trimer The bispecific antibody was developed by the VRCNIAIDNIH and is manufactured under cGMP regulations at the VRC Pilot Plant operated under contract by the Vaccine Clinical Materials Program VCMP Leidos Biomedical Research Inc Frederick MD
Participants
Healthy adults 18-60 years of age
Study Plan
This open-label study will include 6 groups to evaluate CAP256J3LS administered one time or by repeat dosing Enrollment will begin with the 5 mgkg dose groups and enrollment for subsequent dose groups will proceed after dose-escalation safety reviews Assessment of safety will include solicited reactogenicity and other adverse events clinical observations and monitoring of hematological and chemistry parameters at clinical visits throughout the 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