Phase 1 Completed N=20 Randomized Quadruple-blind Treatment

Safety and Tolerability of PRO 140 in HIV Uninfected Male Volunteers

HIV

Source: ClinicalTrials.gov NCT00110591 ↗

Enrolled (actual)

Serious AEs

5.0%

Results posted

Mar 2023

Primary outcomePrimary: Safety and Tolerability of PRO 140 — 4; 4; 0; 4 number of subjects reporting AEs

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Safety and Tolerability of PRO 140	4; 4; 0; 4; 3	—

Eligibility Criteria

Inclusion Criteria

Not more than 20% below or 20% above ideal weight for height and estimated frame size
Good health, with no clinically significant abnormal findings on the physical examination, medical history, or laboratory tests

Exclusion Criteria

History of clinically significant disease
History of clinically significant allergies, including drug allergy
Participated in another clinical trial within the 3 months prior to study entry
HIV infected
Hepatitis B or C virus infected
Active significant infection
Prior exposure, allergy, or known hypersensitivity to PRO 140

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00110591). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.