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Not Yet RecruitingPhase 1ACTRN12608000412336

Part 3 of a study to evaluate the safety of a single dose of increasing amounts of INO-4885 given via a vein to healthy adult male volunteers

A Phase I, Single-Center, Randomized, Single-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Study to Evaluate the Tolerability, Safety, and Pharmacokinetics of an Intravenous Infusion of INO-4885 Administered to Healthy Adult Male Volunteers – Part 3

Sponsor

Inotek Pharmaceuticals Corporation

Enrollment

12 participants

Start Date

Aug 17, 2008

Study Type

Interventional

Conditions

No specific health condition being studied - the study is being conducted for safety reasons in healthy male volunteers that do not belong to any target population for the given intervention

Summary

The goal of this study is to evaluate the safety of increasing doses of an experimental drug called INO-4885. In the earlier, completed parts (Parts 1 and 2) of this study, a single dose on INO-4885 at 1-600 micrograms per kilogram body weight was given to healthy male volunteers via a catheter placed in an arm vein. In Part 3 of this study, one dose of 1200 micrograms per kilogram body weight will be given to healthy male volunteers. Safety assessments will include physical examinations, routine blood and urine tests, electrocardiograms, blood and urine levels of INO-4885, and other indicators of safety will be recorded and analyzed.

Eligibility

Sex: MalesMin Age: 18 YearssMax Age: 45 Yearss

Plain Language Summary

Simplified for easier understanding

This early-phase safety study is testing increasing doses of an experimental drug called INO-4885 given through an intravenous infusion in healthy men. The goal is to determine what doses are safe and how the body processes the drug. It is for healthy men aged 18 to 45 who weigh between 65 and 100 kg.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

In the completed Parts 1 and 2 of this trial, the tolerability and safety of intravenous doses of INO-4885 ranging from 1-600 mcg/kg administered to healthy adult volunteers was established . Based up

In the completed Parts 1 and 2 of this trial, the tolerability and safety of intravenous doses of INO-4885 ranging from 1-600 mcg/kg administered to healthy adult volunteers was established . Based upon these findings and animals toxicology (safety ) studies, 1200 mcg/kg of INO-4885 will be administered intravenously to healthy adult volunteers in this trial (Part 3) at a rate of 15 mL/min.

Locations(1)

Australia

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ACTRN12608000412336