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Study to Evaluate Safety and Pharmacokinetics of UB-421 Antibody in HIV-1 Infected Adults

Sponsor
United Biomedical (Industry)
Overall Status
Completed
CT.gov ID
NCT01140126
Collaborator
(none)
20
Enrollment
2
Locations
1
Arm
14
Duration (Months)
10
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Antibody UB-421
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
May 1, 2010
Actual Primary Completion Date :
Jul 1, 2011
Actual Study Completion Date :
Jul 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Antibody (UB-421)

Drug: Antibody UB-421
Single intravenous infusion at day 0 of a liquid dose of 1, 5, 10 or 25 mg/kg body weight.

Outcome Measures

Primary Outcome Measures

  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 Outcome Measures

  1. To determine pharmacokinetic parameters of a single intravenous infusion at escalating doses of UB-421. [Screen, treatment & follow-up: 62 to 90 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Asymptomatic, treatment-naive, HIV-1 seropositive

  • CD4+ T cell count >350 cells/cubic millimeter

  • HIV-1 viral load >5,000 copies/mL

  • Other inclusion criteria apply

Exclusion Criteria:

  • 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

  • Other exclusion criteria apply

Contacts and Locations

Locations

Site City State Country Postal Code
1 Taipei Veterans General Hospital (TVGH) Taipei City Beitou District Taiwan 11217
2 Kaohsiung Veterans General Hospital (KVGH) Kaohsiung City Zuoying District Taiwan 81362

Sponsors and Collaborators

  • United Biomedical

Investigators

  • 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 Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01140126
Other Study ID Numbers:
  • UBI Protocol A101
  • Protocol A101-HIV
First Posted:
Jun 9, 2010
Last Update Posted:
Jul 11, 2011
Last Verified:
Jul 1, 2011
Keywords provided by , ,
HIV-1, CD4, antibody, immunotherapy
Additional relevant MeSH terms:
UB-421
Antibodies

Study Results

No Results Posted as of Jul 11, 2011