Safety Study of Ibalizumab Subcutaneous Injection in Healthy Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: Prevention of Infection With HIV-1

In brief

The is a blinded safety study of ibalizumab given by subcutaneous injection in sequentially increasing dose-groups of at-risk, HIV-negative, healthy volunteers. The study involves the administration of four total injections of ibalizumab or matching placebo in each volunteer, given once every week, at one of three dose levels. Drug administration begins at the lowest dose. After 4 of 8 volunteers in the first group have received all study drug injections and have completed 6 additional weeks of follow-up, an independent safety monitoring group will review available data before approving initiation of the next higher dose-group. This process will be repeated prior to initiation of the 3rd and highest dose-group. All volunteers will participate in 2 separate intensive blood sampling periods of 7 days each to test drug levels.

Key facts

Study ID

NCT01292174

Run by

TaiMed Biologics Inc.

People needed

25

Starts

2011-02-01

Expected to finish

2012-09-01

Last updated by the study team

2012-12-18

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• At-risk adult males and females, as assessed by a medical history, physical exam, and laboratory tests
• At least 18 years of age and no greater than 40 years on the day of screening
• Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study
• In the opinion of the principal investigator or designee, has understood the information provided; written informed consent needs to be given before any study-related procedures are performed
• Willing to undergo HIV Testing and counseling, and receive HIV test results
• Agrees to use a barrier form of contraception if engaging in sexual activity at any time throughout the study and the follow-up period (males and females) - two reliable forms of contraception, one barrier and one hormonal (e.g., oral contraceptive pill, injectable or implantable contraceptive combined with diaphragm, Intra Uterine Device (IUD), or condoms), must be used if volunteers engage in sexual activity that could result in pregnancy; is anatomically sterile in self or partner; all female volunteers must be willing to undergo urine pregnancy tests at time points indicated in the Schedule of Events and Procedures

You may not qualify if…

• Confirmed HIV-1 or HIV-2 infection
• Any clinically significant abnormality on history or examination including history of immunodeficiency or autoimmune disease; use of systemic corticosteroids, immunosuppressive, anticancer, or other medications considered significant by the trial physician within the last 6 months
• Any clinically significant acute or chronic medical condition requiring care of a physician (e.g., diabetes, coronary artery disease, rheumatologic illness, malignancy, substance abuse) that in the opinion of the investigator would preclude participation
• Any laboratory value of Grade 1 or higher according to the NCI Common Toxicity Criteria
• Confirmed diagnosis of hepatitis B (surface antigen, HbsAg) or hepatitis C (HCV antibodies)
• Current confirmed STD infection
• Prior receipt of Hepatitis A vaccine by history, or anti-hepatitis A antibodies at screening
• Pregnant, planning a pregnancy during the trial period, or lactating
• Receipt of a live attenuated vaccine (other than influenza) within 30 days or other vaccine within 14 days of study enrollment
• Receipt of blood transfusion or blood products 6 months prior to study drug administration
• Participation in another clinical study of an investigational product currently or within 30 days prior to Screening, or expected participation during this study
• History of severe allergic reactions or known allergy to any component of the study drug
• Major psychiatric illness including any history of schizophrenia or severe psychosis, bipolar disorder requiring therapy, suicide attempt in the previous 3 years
• In the opinion of the investigator, unlikely to comply with protocol

Where it is running

• Alabama Vaccine Research Center — Birmingham, Alabama, United States
• Living Hope Clinical Foundation — Long Beach, California, United States
• Quest Clinical Research — San Francisco, California, United States
• ACRIA - AIDS Community Research Initiative of America — New York, New York, United States
• University of Rochester — Rochester, New York, United States
• Research Access Network / The Schrader Clinic — Houston, Texas, United States

Full record on ClinicalTrials.gov

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