Phase I Clinical Trial Results
A Randomized Double Blind Phase 1a Clinical Trial of THR-18, a PAI-1 Derived Peptide, in Normal Volunteers.
Thrombotech conducted a randomized double blind phase 1 clinical trial to assess the safety of THR-18. The study, led by of Prof.
Ronen Leker, Head of the Stroke unit at Hadassah Medical Center, was designed to assess the safety of THR-18 in healthy volunteers.
The volunteers were treated with five different dose and dose regimen tiers of THR-18 or placebo and were carefully monitored for the
occurrence of any side effects. Pharmacokinetiks and pharmacodynamics were also studied.
The results of the first-in-human double blind safety study show that THR-18 is safe in healthy human volunteers. THR-18 was well
tolerated, with no effect on body temperature, respiratory rate and safety laboratory tests. All observed adverse events (AEs) were
transient, and no major differences in the incidence of AEs were observed over the different dose groups, and good local tolerance at
injection site was observed. No serious adverse events were observed.
The results of the Phase I study allowed Thrombotech to continue to the next stages of clinical development for THR-18, and further
studies aiming to determine its safety and efficacy in stroke patients are ongoing. |
