This is a Phase 1b, randomized, double-blind, placebo-controlled, dose escalation study of TRX-100 tablets evaluating the safety, pharmacokinetics, and food effect of single ascending doses of TRX-100 in healthy volunteers.
Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
Adult males and females, 18 to 65 years of age (inclusive) at screening.
Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2, with a body weight (to 1 decimal place) ≥ 50.0 kg at screening.
Physical examination without any clinically significant findings in the opinion of the investigator.
History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or major surgery within the past 3 months determined by the PI to be clinically significant.
History of surgery or hospitalisation within 30 days prior to screening, or surgery planned during the study.
Acute infections within 4 weeks prior to screening or current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medications.
Presence or history of any abnormality or illness, including gastrointestinal surgery, liver, kidney, or other conditions, which in the opinion of the PI may affect absorption, distribution, metabolism or elimination of the study drug.
Sequential
TRX-100 or placebo
DrugThe patient will receive TRX-100 or placebo
Incidence of TEAEs
Number of participants with treatment-emergent adverse events
Incidence of SAEs and AEs leading to discontinuation
Number of participants with serious AEs (SAEs) and AEs leading to discontinuation
Maximum observed concentration (Cmax)
A measure of maximum observed concentration
Time to Cmax (Tmax)
A measure of Time to Cmax
Area under the concentration-time curve from 0 to time of last quantifiable concentration (AUC0-last)
A measure of area under the concentration-time curve from 0 to time of last quantifiable concentration
Area under the concentration-time curve from 0 to 24 hours (AUC0-24)
A measure of area under the concentration-time curve from 0 to 24 hours
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