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(YCO-0971) First-in-human study of 10-1074-LS alone and in combination with 3BNC117-LS


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A Phase 1, Dose Escalation, First-in-Human Study of the Safety and Pharmacokinetics of the Subcutaneous and Intravenous Administration of 10-1074-LS Alone and in Combination with 3BNC117-LS 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. 10-1074 and 3BNC117 are anti-HIV neutralizing antibodies identified and cloned from two HIV-infected individuals. They were chosen for clinical development for their neutralizing breadth and potency. Both antibodies have shown favorable safety, pharmacokinetics and antiviral activity in clinical trials. 10-1074-LS and 3BNC117-LS are modified versions of the original antibodies and are expected to have extended duration of activity. 3BNC117-LS is currently being evaluated under a separate protocol. This first clinical study of 10-1074-LS will evaluate its safety, tolerability and pharmacokinetics profile when administered alone or in combination with 3BNC117-LS to 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:

- If you are between the ages of 18 and 65
- If you do not have HIV, Hepatitis B or C
- If you have no history of an STD within the last year


Gender:
Both

Age(s):
18-65

Children permitted to participate:
No

Potential Benefits.....




Compensation:
Compensation is provided.