Safety and Tolerability Study of ARC-520 in Healthy Volunteers
|ClinicalTrials.gov Identifier: NCT01872065|
Recruitment Status : Completed
First Posted : June 7, 2013
Last Update Posted : December 10, 2014
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: ARC-520 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ARC-520 in Normal Adult Volunteers|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||November 2014|
Single dose, intravenous administration of ARC-520.
Placebo Comparator: Normal Saline
Single dose, intravenous administration of Normal Saline
- To determine the incidence and frequency of adverse events as a measure of safety and tolerability of ARC-520 [ Time Frame: One month ]The incidence and frequency of adverse events (AEs), serious adverse events (SAEs), related AEs, related SAEs, and AEs leading to withdrawal, dose modification, or treatment discontinuation will be summarized by dose and treatment group.
- To evaluate the pharmacokinetics of ARC-520 at different dose concentrations [ Time Frame: 2 days ]Plasma concentrations following a single dose of ARC-520 at different dose levels will be used to calculate the following ARC-520 pharmacokinetic parameters: Cmax, tmax, AUC0-24, AUCinf, and t1/2. Descriptive statistics of pharmacokinetic parameters will include mean, standard deviation, and coefficient of variation.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01872065
|Nucleus Network Ltd.|
|Melbourne, Victoria, Australia, 3004|
|Principal Investigator:||Jason Lickliter, MD, PhD||Nucleus Network Ltd|