Study of TRX-100 Tablets Evaluating the Safety, Pharmacokinetics, and Food Effect in Healthy Volu… (NCT07526506) | Clinical Trial Compass
RecruitingPhase 1
Study of TRX-100 Tablets Evaluating the Safety, Pharmacokinetics, and Food Effect in Healthy Volunteers
Australia24 participantsStarted 2026-03-25
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Medically healthy without clinically significant abnormalities (in the opinion of the Investigator) at the screening visit, including:
✓. Physical examination without any clinically significant findings in the opinion of the investigator.
✓. Systolic blood pressure in the range of 90 mm Hg to 149 mm Hg; diastolic blood pressure in the range of 50 mm Hg to 90 mm Hg after 5 minutes in a supine or semi-supine position.
✓. Heart rate (HR) in the range of 40 to 100 bpm after 5 minutes in a supine position
✓. Body temperature (tympanic or oral) in the range 35.5°C to 37.5°C (inclusive).
Exclusion criteria
✕. 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.
What they're measuring
1
Incidence of TEAEs
Timeframe: up to Day 28
2
Incidence of SAEs and AEs leading to discontinuation
✕. 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.
✕. Any history of malignant disease in the last 5 years (excludes surgically resected skin squamous cell or basal cell carcinoma).
✕. Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia.
✕. Use of or plans to use systemic immunosuppressive (e.g., corticosteroids by any route, methotrexate, azathioprine, cyclosporine) or immunomodulating medications (e.g., interferon) during the study and within 5 half-lives of individual agent or within 28 days (whichever is longer) prior to dosing.
✕. Use of or plans to use agents (e.g., grapefruit and grapefruit products) that have clinically significant interaction with CYP3A4 or the use of any medications that could have a significantly impact on organ function (e.g., barbiturates, omeprazole, cimetidine) during the study and within 5 half-lives of individual agent or within 7 days (whichever is longer) prior to dosing.