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

This study has been completed.
Sponsor:
Collaborators:
Aaron Diamond AIDS Research Center
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
TaiMed Biologics Inc.
ClinicalTrials.gov Identifier:
NCT01292174
First received: February 7, 2011
Last updated: December 17, 2012
Last verified: December 2012
  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:


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:

  1. At-risk adult males and females, as assessed by a medical history, physical exam, and laboratory tests
  2. At least 18 years of age and no greater than 40 years on the day of screening
  3. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study
  4. 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
  5. Willing to undergo HIV Testing and counseling, and receive HIV test results
  6. 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:

  1. Confirmed HIV-1 or HIV-2 infection
  2. 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
  3. 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
  4. Any laboratory value of Grade 1 or higher according to the NCI Common Toxicity Criteria
  5. Confirmed diagnosis of hepatitis B (surface antigen, HbsAg) or hepatitis C (HCV antibodies)
  6. Current confirmed STD infection
  7. Prior receipt of Hepatitis A vaccine by history, or anti-hepatitis A antibodies at screening
  8. Pregnant, planning a pregnancy during the trial period, or lactating
  9. Receipt of a live attenuated vaccine (other than influenza) within 30 days or other vaccine within 14 days of study enrollment
  10. Receipt of blood transfusion or blood products 6 months prior to study drug administration
  11. Participation in another clinical study of an investigational product currently or within 30 days prior to Screening, or expected participation during this study
  12. History of severe allergic reactions or known allergy to any component of the study drug
  13. Major psychiatric illness including any history of schizophrenia or severe psychosis, bipolar disorder requiring therapy, suicide attempt in the previous 3 years
  14. 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
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014