ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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2 results sorted by trial registration date.
  • A 2-part, randomized, double-blind, placebo-controlled study of the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of FTP 198 in healthy volunteers

    The research project is testing a potential new treatment for Idiopathic pulmonary fibrosis (IPF), called FTP-198. Before a new medicine can be approved for use in humans, it is necessary to confirm that it is safe and effective. Although laboratory and animal studies have been completed, this is the first time FTP-198 is being tested in humans. Therefore, side effects in human are unknown. Thus, the purpose of this study is to evaluate the safety and tolerability of single and multiple doses of FTP-198. The pharmacokinetics (PK) of FTP-198 in humans will also be determined. PK testing involves taking blood samples to measure how much of the drug gets into the blood stream, and how long the body takes to remove it or excrete it. When testing for PK, your sample will also be tested to determine the amount of LPA in your blood. This is called a pharmacodynamic (PD) parameter.

  • Safety, Tolerability and Pharmacokinetics of FTP-198 in Healthy Australian Volunteers

    This is a first-in-human, Phase I, single-dose escalation and multiple-dose escalation clinical trial for FTP-198 conducted in Australian healthy volunteers. The safety, tolerability, and pharmacokinetics of FTP-198 suspension in healthy volunteers will be evaluated using a randomized, double-blind, placebo-controlled trial design.

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