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Safety and Tolerability of PRO 140 in HIV Uninfected Male Volunteers

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00110591
Enrollment
20
Registered
2005-05-11
Start date
2004-04-16
Completion date
2008-03-31
Last updated
2023-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Brief 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.

Detailed description

PRO 140 is a man-made monoclonal antibody to the chemokine receptor CCR5, which serves as a co-receptor for HIV. In numerous preclinical models of HIV infection, PRO 140 broadly and potently blocks CCR5-mediated HIV entry without blocking the natural activity of CCR5. PRO 140 is being developed for therapy of HIV infected individuals. The purpose of this study is to evaluate the safety and tolerability of PRO 140 in HIV uninfected male volunteers. The pharmacokinetics and pharmacodynamics of PRO 140 will also be assessed in this study. Participants in this study will be randomly assigned to receive a single dose of one of several possible doses of PRO 140 or placebo. Participants will remain in the clinic for observation and evaluation for 24 hours after the single-dose administration. Follow-up visits will occur at 2, 3, 5, 7, 10, 14, 28, 42, and 60 days post-treatment. Physical exams, electrocardiograms (ECGs), vital signs measurement, adverse event reporting, and blood and urine collection will occur at most visits.

Interventions

DRUGPRO 140

Monoclonal antibody to CCR5

Sponsors

CytoDyn, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Safety and Tolerability of PRO 14060 days

Countries

United States

Participant flow

Participants by arm

ArmCount
Placebo
Intravenous placebo for PRO 140 PRO 140: Monoclonal antibody to CCR5
4
PRO 140 Dose 1
0.1 mg/kg PRO 140 by intravenous infusion PRO 140: Monoclonal antibody to CCR5
4
PRO 140 Dose 2
0.5 mg/kg PRO 140 by intravenous infusion PRO 140: Monoclonal antibody to CCR5
4
PRO 140 Dose 3
2.0 mg/kg PRO 140 by intravenous infusion PRO 140: Monoclonal antibody to CCR5
4
PRO 140 Dose 4
5.0 mg/kg PRO 140 by intravenous infusion PRO 140: Monoclonal antibody to CCR5
4
Total20

Baseline characteristics

CharacteristicPRO 140 Dose 4TotalPlaceboPRO 140 Dose 1PRO 140 Dose 2PRO 140 Dose 3
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
4 Participants20 Participants4 Participants4 Participants4 Participants4 Participants
Age, Continuous21 years
STANDARD_DEVIATION 2
27 years
STANDARD_DEVIATION 9
26 years
STANDARD_DEVIATION 7
34 years
STANDARD_DEVIATION 13
30 years
STANDARD_DEVIATION 12
22 years
STANDARD_DEVIATION 2
Region of Enrollment
United States
4 participants20 participants4 participants4 participants4 participants4 participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Sex: Female, Male
Male
4 Participants20 Participants4 Participants4 Participants4 Participants4 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —— / —
other
Total, other adverse events
4 / 44 / 40 / 44 / 43 / 4
serious
Total, serious adverse events
0 / 41 / 40 / 40 / 40 / 4

Outcome results

Primary

Safety and Tolerability of PRO 140

Time frame: 60 days

ArmMeasureValue (NUMBER)
PlaceboSafety and Tolerability of PRO 1404 number of subjects reporting AEs
PRO 140 Dose 1Safety and Tolerability of PRO 1404 number of subjects reporting AEs
PRO 140 Dose 2Safety and Tolerability of PRO 1400 number of subjects reporting AEs
PRO 140 Dose 3Safety and Tolerability of PRO 1404 number of subjects reporting AEs
PRO 140 Dose 4Safety and Tolerability of PRO 1403 number of subjects reporting AEs

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026