Safety Study of Ibalizumab Subcutaneous Injection in Healthy Volunteers

NCT01292174 | Completed Phase 1 DMC

• 1 other identifier: TMB-108
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 6

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.

Conditions

Prevention of Infection With HIV-1

Keywords

HIV prevention

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety and tolerability of subcutaneous administration of ibalizumab in at-risk HIV-negative volunteers

  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

  30 weeks

Study Arms (3)

Group 1 - lowest dosage

EXPERIMENTAL

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

Group 2 - middle dosage level

EXPERIMENTAL

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

Group 3 - highest dosage level

EXPERIMENTAL

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

Interventions

ibalizumab (biologic/MAb) for SC Injection or placebo BIOLOGICAL

ibalizumab or matching placebo administered by subcutaneous injection weekly at 120 mg

Also known as: formerly TNX-355

Group 1 - lowest dosage

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TaiMed Biologics Inc.: lead
• Aaron Diamond AIDS Research Center: collaborator
• Bill and Melinda Gates Foundation: collaborator

Study Sites (6)

Alabama Vaccine Research Center

Birmingham, Alabama, 35294-2050, United States

Location

Living Hope Clinical Foundation

Long Beach, California, 90813, United States

Location

Quest Clinical Research

San Francisco, California, 94115, United States

Location

ACRIA - AIDS Community Research Initiative of America

New York, New York, 10018, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Research Access Network / The Schrader Clinic

Houston, Texas, 77098, United States

Location

MeSH Terms

Interventions

ibalizumab

Study Officials

• Stanley T Lewis, MD, MPH

  TaiMed Biologics, USA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2011
• First Posted: February 9, 2011
• Study Start: February 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: December 18, 2012

Record last verified: 2012-12

Locations

US (6)