Safety Study of Ibalizumab Subcutaneous Injection in Healthy Volunteers
Condition: Prevention of Infection With HIV-1
Study type: Interventional
Phase: Phase 1

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).
    

Intervention name(s): ibalizumab (biologic/MAb) for SC Injection or placebo; ibalizumab (biologic/MAb) for SC Injection or placebo; ibalizumab (biologic/MAb) for SC Injection or placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): ibalizumab or matching placebo administered by subcutaneous injection weekly at 120 mg; ibalizumab or matching placebo administered by subcutaneous injection weekly at 240 mg; ibalizumab or matching placebo administered by subcutaneous injection weekly at 480 mg
Other intervention name(s): formerly TNX-355; formerly TNX-355; formerly TNX-355
Intervention MeSH terms: Ibalizumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HIV prevention