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(YCO-0946) 3BNC117-LS First-in-Human Phase 1 Study


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A phase 1, dose escalation, first-in-human study of the safety and pharmacokinetics of 3BNC117-LS administered intravenously in HIV-infected and HIV-uninfected individuals

Principal Investigator:
Yehuda Cohen MD

Investigators:

Contact Information:
Clinical Research Support Office
1230 York Avenue
New York, NY 10065
Telephone: 1.800.RUCARES
Email: RUCARES@Rockefeller.edu
Enrollment Status:
Open to Enrollment

Brief Summary of Protocol:
Broadly neutralizing antibodies against HIV arise in a small fraction of HIV-infected individuals. These antibodies might be able to play an important role in protection from acquisition of HIV infection, and also have the potential to alter the course of HIV infection. 3BNC117 is an anti-HIV neutralizing antibody identified and cloned from an HIV-infected individual. It was chosen for clinical development for its neutralizing breadth and potency, and has been shown to have antiretroviral activity in clinical trials. 3BNC117-LS is a modified version of 3BNC117 that extends the duration of action and the time between administrations. This first clinical study of 3BNC117-LS will evaluate the safety, tolerability and pharmacokinetics profile of 3BNC117-LS at three increasing dose levels (3, 10 and 30 mg/kg) in both HIV-infected and HIV-uninfected individuals.



Detailed Description of Protocol:




What specifically makes a person eligible for the study?
You may be eligible to enter this study:

• Are between the ages of 18 and 65
• Are HIV positive
• Do not have Hepatitis B or C


Gender:
Both

Age(s):
18-65

Children permitted to participate:
No

Potential Benefits.....




Compensation: