Safety Study of Ibalizumab Subcutaneous Injection in Healthy Volunteers - Full Text View

Purpose

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.

Condition	Intervention	Phase
Prevention of Infection With HIV-1	Biological: ibalizumab (biologic/MAb) for SC Injection or placebo	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, Sequential Dose-Escalation Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered Ibalizumab in HIV-Negative, At-Risk Volunteers

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by TaiMed Biologics Inc.:

Primary Outcome Measures:

To evaluate the safety and tolerability of subcutaneous administration of ibalizumab in at-risk HIV-negative volunteers [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]
Safety and Tolerability Measures Include:
- Physical examinations
- Vital sign measurements
- Anti-ibalizumab antibody levels (immunogenicity of ibalizumab)
- Clinical laboratory parameters (hematology, serum chemistry and urinalysis)
- Urine or serum pregnancy tests
- Adverse events
- Serious Adverse Events


Enrollment:	25
Study Start Date:	February 2011
Study Completion Date:	September 2012
Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group 1 - lowest dosage 120 mg ibalizumab administered by subcutaneous injection weekly for 4 weeks, randomized 6:2 with placebo	Biological: ibalizumab (biologic/MAb) for SC Injection or placebo ibalizumab or matching placebo administered by subcutaneous injection weekly at 120 mg Other Name: formerly TNX-355
Experimental: Group 2 - middle dosage level 240 mg ibalizumab administered by subcutaneous injection weekly for 4 weeks, randomized 6:2 with placebo	Biological: ibalizumab (biologic/MAb) for SC Injection or placebo ibalizumab or matching placebo administered by subcutaneous injection weekly at 240 mg Other Name: formerly TNX-355
Experimental: Group 3 - highest dosage level 480 mg ibalizumab administered by subcutaneous injection weekly for 4 weeks, randomized 6:2 with placebo	Biological: ibalizumab (biologic/MAb) for SC Injection or placebo ibalizumab or matching placebo administered by subcutaneous injection weekly at 480 mg Other Name: formerly TNX-355

Detailed Description:

The study is a phase 1, randomized, double-blinded, placebo-controlled, sequential dose-escalation and safety study of ibalizumab in at-risk HIV-negative volunteers. The study involves the administration of four total injections of ibalizumab or matching placebo in each volunteer, given once every week, in one of three groups as defined below:

Group 1: 120 mg sc weekly x 4 weeks, randomized 6:2 with placebo Group 2: 240 mg sc weekly x 4 weeks, randomized 6:2 with placebo Group 3: 480 mg sc weekly x 4 weeks, randomized 6:2 with placebo

Volunteers will be screened up to 42 days prior to enrollment and first drug administration, and will be followed for 26 weeks after the final injection.

All subjects will be expected to participate in two (2) intense PK sampling periods with a duration of 7 days for the first period and 14 days for the second period. During these periods (following Day 0 and following Week 3) subjects will have daily serum concentration and other investigational pharmacokinetic assessments.

All volunteers will be encouraged to participate in an optional collection of genital secretions (semen or vaginal wash) at Week 4.

An independent data safety monitoring board (DSMB) will review study data after four out of eight at-risk HIV-negative volunteers in Group 1 (120 mg dose) have received all study drug injections and completed 6 weeks of follow-up before approving escalation to Group 2 (240 mg dose). The DSMB will also review all available study data from Groups 1, and 2 after four out of eight volunteers in Group 2 have received all study drug injections and completed 6 weeks of follow-up before approving escalation to Group 3 (480 mg dose).

Eligibility


Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01292174

Locations


United States, Alabama
Alabama Vaccine Research Center
Birmingham, Alabama, United States, 35294-2050
United States, California
Living Hope Clinical Foundation
Long Beach, California, United States, 90813
Quest Clinical Research
San Francisco, California, United States, 94115
United States, New York
ACRIA - AIDS Community Research Initiative of America
New York, New York, United States, 10018
University of Rochester
Rochester, New York, United States, 14642
United States, Texas
Research Access Network / The Schrader Clinic
Houston, Texas, United States, 77098

Sponsors and Collaborators

TaiMed Biologics Inc.

Aaron Diamond AIDS Research Center

Bill and Melinda Gates Foundation

Investigators


Study Director:	Stanley T Lewis, MD, MPH	TaiMed Biologics, USA

More Information

No publications provided


Responsible Party:	TaiMed Biologics Inc.
ClinicalTrials.gov Identifier:	NCT01292174 History of Changes
Other Study ID Numbers:	TMB-108
Study First Received:	February 7, 2011
Last Updated:	December 17, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by TaiMed Biologics Inc.:


HIV prevention

Additional relevant MeSH terms:


Antibodies, Monoclonal Immunologic Factors Pharmacologic Actions Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 27, 2015

Safety Study of Ibalizumab Subcutaneous Injection in Healthy Volunteers (TMB-108)