Study to Evaluate Safety and Pharmacokinetics of UB-421 Antibody in HIV-1 Infected Adults
A Phase I, Open-label, Single-dose, Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of the UB-421 Antibody in Asymptomatic HIV-1 Infected Adults
2 other identifiers
interventional
20
1 country
2
Brief Summary
The purpose of this Phase I study is to determine whether the antibody (UB-421), targeting the HIV-1 receptor on the CD4 molecule (domain 1) of T-lymphocytes and monocytes, is safe and well tolerated when administered to asymptomatic HIV-1 infected adults by intravenous infusion and to assess pharmacokinetic parameters of the antibody in blood and on cells. The neutralizing activity of UB-421 blocks HIV-1 from binding to its receptor on CD4-positive cells; thus, UB-421 functions as an immunotherapeutic intervention to prevent HIV-1 infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2010
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 7, 2010
CompletedFirst Posted
Study publicly available on registry
June 9, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedJuly 11, 2011
July 1, 2011
1.2 years
June 7, 2010
July 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate safety and tolerability of a single intravenous infusion at escalating doses of UB-421.
Screen, treatment & follow-up: 62 to 90 days
Secondary Outcomes (1)
To determine pharmacokinetic parameters of a single intravenous infusion at escalating doses of UB-421.
Screen, treatment & follow-up: 62 to 90 days
Study Arms (1)
Antibody (UB-421)
EXPERIMENTALInterventions
Single intravenous infusion at day 0 of a liquid dose of 1, 5, 10 or 25 mg/kg body weight.
Eligibility Criteria
You may qualify if:
- Asymptomatic, treatment-naive, HIV-1 seropositive
- CD4+ T cell count \>350 cells/cubic millimeter
- HIV-1 viral load \>5,000 copies/mL
You may not qualify if:
- Active infection requiring immediate therapy (except HIV-1)
- Prior participation in any HIV vaccine trial
- Previous exposure to a monoclonal antibody
- Use of immunomodulating drugs or systemic chemotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Taipei Veterans General Hospital (TVGH)
Taipei, Beitou District, 11217, Taiwan
Kaohsiung Veterans General Hospital (KVGH)
Kaohsiung City, Zuoying District, 81362, Taiwan
Related Publications (1)
Wang CY, Sawyer LS, Murthy KK, Fang X, Walfield AM, Ye J, Wang JJ, Chen PD, Li ML, Salas MT, Shen M, Gauduin MC, Boyle RW, Koup RA, Montefiori DC, Mascola JR, Koff WC, Hanson CV. Postexposure immunoprophylaxis of primary isolates by an antibody to HIV receptor complex. Proc Natl Acad Sci U S A. 1999 Aug 31;96(18):10367-72. doi: 10.1073/pnas.96.18.10367.
PMID: 10468614BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Wing Wai Wong, M.D.
Taipei Veterans General Hospital (TVGH), Taiwan
- PRINCIPAL INVESTIGATOR
Hung Chin Tsai, M.D.
Kaohsiung Veterans General Hospital (KVGH), Taiwan
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 7, 2010
First Posted
June 9, 2010
Study Start
May 1, 2010
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
July 11, 2011
Record last verified: 2011-07