CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 20 enrolled
Drug / intervention
PRO 140drug
Likely dose
PRO 140 single ascending doses (specific dose levels not stated in provided text)AI-extracted
Key inclusion· 2
  • ✓Weight within 20% of ideal body weight for height and frame size
  • ✓Good overall health with no clinically significant abnormalities on physical exam, medical history, or labs
Key exclusion· 7
  • ✕History of clinically significant disease
  • ✕History of clinically significant allergies, including drug allergy
  • ✕HIV infection
  • ✕Hepatitis B or C infection

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00110591
NCT00110591Phase 1Completed
CompareCT.gov

A Phase I, Randomized, Double Blind, Placebo Controlled, Single-Dose, Rising Dose Cohort Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PRO 140 in Healthy Volunteers

CytoDyn, Inc.·interventional·Posted May 11, 2005·Updated Mar 14, 2023

In Brief

A Phase 1 clinical trial evaluating PRO 140 for HIV Infections. Completed, enrolled 20 participants across 1 site.

Detailed Summary

The purpose of the study is to determine the safety and tolerability of PRO 140, an investigational anti-HIV drug, administered via intravenous infusion. Study hypothesis: Single intravenous doses of PRO 140 can be safely administered to humans and will result in measurable concentrations of the product in serum.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 11, 2005
Enrollment StartApr 16, 2004
Primary CompletionNov 7, 2005
Study CompletionMar 31, 2008
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 21.1 years ago

Interventions

PRO 140drug

Monoclonal antibody to CCR5