NCT02511990

A Study of the Safety, Pharmacokinetics and Antiretroviral Activity of 10-1074

A Phase 1, Open Label, Dose-escalation Study of the Safety, Pharmacokinetics and Antiretroviral Activity of 10-1074 Monoclonal Antibody in HIV-infected and HIV-uninfected Individuals

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Rockefeller University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a phase 1 clinical trial to evaluate the safety, pharmacokinetics and the antiretroviral effects of the highly neutralizing anti-HIV-1 monoclonal antibody 10-1074 in HIV-infected and HIV-uninfected individuals.

Detailed description

In preclinical studies carried out in humanized mice and non-human primates, 10-1074 alone or in combination with other neutralizing antibodies led to protection from HIV or simian/human immunodeficiency virus (SHIV) infection and also to sustained suppression of HIV plasma viremia. The aims of this protocol are to evaluate the safety, tolerability and pharmacokinetics profile of 10-1074 in both HIV-infected and HIV-uninfected individuals, and its antiretroviral activity in HIV-infected individuals.

Conditions

• Healthy
• HIV

Interventions

Type	Name	Description
BIOLOGICAL	3 mg/kg, single dose IV administration of 10-1074	3 mg/kg, single dose IV administration of 10-1074
BIOLOGICAL	10 mg/kg, single dose IV administration of 10-1074	10 mg/kg, single dose IV administration of 10-1074
BIOLOGICAL	30 mg/kg, single dose IV administration of 10-1074	30 mg/kg, single dose IV administration of 10-1074

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-12-01
• Completion: 2017-12-01
• First posted: 2015-07-30
• Last updated: 2018-02-05

Locations

2 sites across 2 countries: United States, Germany