Study to Evaluate Safety and Pharmacokinetics of UB-421 Antibody in HIV-1 Infected Adults
This study has been completed.
Sponsor:
United Biomedical
Information provided by:
United Biomedical
ClinicalTrials.gov Identifier:
NCT01140126
First received: June 7, 2010
Last updated: July 7, 2011
Last verified: July 2011
| Tracking Information | |||||||||
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| First Received Date ICMJE | June 7, 2010 | ||||||||
| Last Updated Date | July 7, 2011 | ||||||||
| Start Date ICMJE | May 2010 | ||||||||
| Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
To evaluate safety and tolerability of a single intravenous infusion at escalating doses of UB-421. [ Time Frame: Screen, treatment & follow-up: 62 to 90 days ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01140126 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
To determine pharmacokinetic parameters of a single intravenous infusion at escalating doses of UB-421. [ Time Frame: Screen, treatment & follow-up: 62 to 90 days ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Study to Evaluate Safety and Pharmacokinetics of UB-421 Antibody in HIV-1 Infected Adults | ||||||||
| Official Title ICMJE | 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 | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 | ||||||||
| Study Design ICMJE | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | HIV-1 Infection in Adults (Asymptomatic) | ||||||||
| Intervention ICMJE | Drug: Antibody UB-421
Single intravenous infusion at day 0 of a liquid dose of 1, 5, 10 or 25 mg/kg body weight.
Other Name: N.A. |
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| Study Arm (s) | Experimental: Antibody (UB-421)
Intervention: Drug: Antibody UB-421 |
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| Publications * | 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. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 20 | ||||||||
| Completion Date | July 2011 | ||||||||
| Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 20 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Taiwan | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01140126 | ||||||||
| Other Study ID Numbers ICMJE | UBI Protocol A101, Protocol A101-HIV | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Wing Wai Wong, M.D., Taipei Veterans General Hospital (TVGH), Taiwan | ||||||||
| Study Sponsor ICMJE | United Biomedical | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | United Biomedical | ||||||||
| Verification Date | July 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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