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Monoclonal Antibodies

Antibody Treatment for HIV

Phase 1
Recruiting
Led By Joseph P Casazza, M.D.
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant must be 18 to 60 years of age
Participant must have adequate venous access if assigned to an IV group or adequate abdominal subcutaneous tissue if assigned to a SC group
Must not have
Woman who is breast-feeding or planning to become pregnant during study participation
Participant with weight > 115 kg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout the study
Awards & highlights
No Placebo-Only Group

Summary

"This trial is testing a new product called CAP256J3LS, which uses antibodies to potentially prevent HIV infections. The objective is to see if this new product is safe for healthy individuals aged 18

Who is the study for?
This trial is for healthy adults aged 18 to 60 who may help in finding new treatments or prevention methods for HIV/AIDS. Participants will be testing the safety of a new antibody product, CAP256J3LS.
What is being tested?
The study tests CAP256J3LS, an antibody that might prevent HIV infection. It's given either as a shot under the skin or through a vein. Participants are grouped to receive one dose or three doses over several months with regular clinic visits and health monitoring.
What are the potential side effects?
Potential side effects include reactions at the injection site such as redness, swelling, or bruising, and participants will monitor their temperature for fever post-injection which could indicate other side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 60 years old.
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I have good veins for IV treatment or enough belly fat for shots.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently breastfeeding or planning to get pregnant during the study.
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My weight is over 115 kg.
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I haven't taken strong immune system or cancer drugs in the last 4 weeks.
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I have been diagnosed with Gilbert's syndrome.
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I have a history of kidney or liver disease.
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I have a diagnosed bleeding disorder or experience significant bleeding or bruising.
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My high blood pressure is not well controlled.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 24 weeks after product administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and through 24 weeks after product administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety and tolerability of CAP256J3LS ( 20 mg/kg IV) administered for for a total of 3 injections in 12 week intervals to healthy adults
Safety and tolerability of CAP256J3LS ( 5 mg/kg SC) administered for for a total of 3 injections in 12 week intervals to healthy adults
Safety and tolerability of CAP256J3LS ( 5mg/kg or 20mg/kg or 40 mg/kg IV) administered to healthy adults
+1 more
Secondary study objectives
PK will be evaluated at each dose level and route of administration

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups
Experimental Treatment
Group I: Group 6Experimental Treatment1 Intervention
20 mg/kg IV-repeat dosing
Group II: Group 5Experimental Treatment1 Intervention
5 mg/kg SC- repeat dosing
Group III: Group 4Experimental Treatment1 Intervention
40 mg/kg IV- single administration
Group IV: Group 3Experimental Treatment1 Intervention
20 mg/kg IV- single administration
Group V: Group 2Experimental Treatment1 Intervention
5 mg/kg SC- single administration
Group VI: Group 1Experimental Treatment1 Intervention
5 mg/kg IV- single administration

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,336 Previous Clinical Trials
5,382,774 Total Patients Enrolled
Joseph P Casazza, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
2 Previous Clinical Trials
35 Total Patients Enrolled
~40 spots leftby Jun 2026
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