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

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ClinicalTrials.gov Identifier: NCT01292174
Recruitment Status : Completed
First Posted : February 9, 2011
Last Update Posted : December 18, 2012
Sponsor:
Collaborators:
Aaron Diamond AIDS Research Center
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
TaiMed Biologics Inc.

Tracking Information
First Submitted Date  ICMJE February 7, 2011
First Posted Date  ICMJE February 9, 2011
Last Update Posted Date December 18, 2012
Study Start Date  ICMJE February 2011
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2011)
To evaluate the safety and tolerability of subcutaneous administration of ibalizumab in at-risk HIV-negative volunteers [ Time Frame: 30 weeks ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of Ibalizumab Subcutaneous Injection in Healthy Volunteers
Official Title  ICMJE 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
Brief Summary

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.

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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Prevention of Infection With HIV-1
Intervention  ICMJE
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Group 1 - lowest dosage
    120 mg ibalizumab administered by subcutaneous injection weekly for 4 weeks, randomized 6:2 with placebo
    Intervention: Biological: ibalizumab (biologic/MAb) for SC Injection or placebo
  • Experimental: Group 2 - middle dosage level
    240 mg ibalizumab administered by subcutaneous injection weekly for 4 weeks, randomized 6:2 with placebo
    Intervention: Biological: ibalizumab (biologic/MAb) for SC Injection or placebo
  • Experimental: Group 3 - highest dosage level
    480 mg ibalizumab administered by subcutaneous injection weekly for 4 weeks, randomized 6:2 with placebo
    Intervention: Biological: ibalizumab (biologic/MAb) for SC Injection or placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 17, 2012)
25
Original Estimated Enrollment  ICMJE
 (submitted: February 8, 2011)
24
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01292174
Other Study ID Numbers  ICMJE TMB-108
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party TaiMed Biologics Inc.
Study Sponsor  ICMJE TaiMed Biologics Inc.
Collaborators  ICMJE
  • Aaron Diamond AIDS Research Center
  • Bill and Melinda Gates Foundation
Investigators  ICMJE
Study Director: Stanley T Lewis, MD, MPH TaiMed Biologics, USA
PRS Account TaiMed Biologics Inc.
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP