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

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000412336

Enrollment

Registered

2008-08-22

Start date

2008-08-17

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief 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.

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 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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

Male

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

Subject's body weight between 65 and 100 kg and Body Mass Index between 18 and 29, inclusive.

Exclusion criteria

Subject received treatment or participated in a study with any investigational product within 30 days prior to study drug administration; subject used tobacco, alcohol, caffeine, vitamins, or herbal medications within 48 hours prior to study drug administration; subject used or required any prescription medications during the 4 weeks prior to study drug administration

Outcome results