NCT01292174

Safety Study of Ibalizumab Subcutaneous Injection in Healthy Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: TaiMed Biologics Inc. · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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).

Conditions

• Prevention of Infection With HIV-1

Interventions

Type	Name	Description
BIOLOGICAL	ibalizumab (biologic/MAb) for SC Injection or placebo	ibalizumab or matching placebo administered by subcutaneous injection weekly at 120 mg
BIOLOGICAL	ibalizumab (biologic/MAb) for SC Injection or placebo	ibalizumab or matching placebo administered by subcutaneous injection weekly at 240 mg
BIOLOGICAL	ibalizumab (biologic/MAb) for SC Injection or placebo	ibalizumab or matching placebo administered by subcutaneous injection weekly at 480 mg

Timeline

• Start date: 2011-02-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2011-02-09
• Last updated: 2012-12-18

Locations

6 sites across 1 country: United States