Study of a Human Bispecific HIV Antibody (CAP256J3LS) in Healthy Adults

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This is a study of an experimental product called CAP256J3LS. This study will provide more information about prevention or treatment of human immunodeficiency virus (HIV) infection.

The main purpose of this study is to see if the experimental drug called the CAP256J3LS is safe, and to determine how your body responds to it.

What Does the Study Involve?

If you agree to take part in the study, you will be enrolled into 1 of 6 groups. Each group will get the study product in 1 of 2 ways, and either 1 or 3 times. You will get the study product either in a vein in your arm, intravenously, or under your skin into the belly fat, by subcutaneous injection.

You may need to stay in the clinic for up to 8 hours on the day(s) CAP256J3LS is given. Other clinic visits will take about 1 to 2 hours.

Who Can Participate?

You may be eligible if you

• Are healthy and ages of 18-60 years old.
• Are willing to receive the study product.
• Are not pregnant, breastfeeding or planning to become pregnant during the study.
• Weigh less than 250 lbs.
• Do not have liver disease.

Where Is It Taking Place?

This study is being conducted at the NIH Clinical Center, located on the Metro Red Line Medical Center stop in Bethesda, Maryland.

Is There a Cost?

There are no costs to you for participating in this study. All visits and procedures at NIH Clinical Center are done for research purposes under a protocol plan.

Is Compensation Provided?

You will be compensated for your time and inconvenience by the NIH Clinical Research Volunteer Program. The approximate total amount of compensation is between $2,740 to $5,885 depending upon the group, the number of visits and procedures completed.

If you are unable to finish the study, you will receive only compensation for the parts you completed.

How Many Visits are Required?

The study will include about 14 visits over 6 months for people in who only get CAP256J3LS once.

The study will include about 27 visits over 11 months for people who will get CAP256J3LS three times

What Are The Steps To Participate?

Schedule a telephone prescreen to see if you are initially eligible for this study:

1. Calling: 1-866-833-5433 or 1-866-444-1132 (TTY: 1-866-411-1010)
2. Email: VRCRecruitment@mail.nih.gov
3. Schedule a prescreen:
   https://outlook.office365.com/book/VRCPrescreeningAppointment@nih.onmicrosoft.com/

More Information

Visit: https://www.niaid.nih.gov/clinical-trials/vaccine-research-center-clinical-studies

Visit ClinicalTrials.gov for details.