Actively Recruiting
Study of TRX-100 Tablets Evaluating the Safety, Pharmacokinetics, and Food Effect in Healthy Volunteers
Led by Traws Pharma, Inc. · Updated on 2026-04-13
24
Participants Needed
1
Research Sites
44 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of TRX-100 Tablets Evaluating the Safety, Pharmacokinetics, and Food Effect in Healthy Volunteers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must provide written informed consent and understand the study risks and purpose.
- Adults aged 18 to 65 years at screening.
- Body mass index between 18.5 and 32.0 kg/m2 and body weight at least 50.0 kg.
- Medically healthy without significant abnormalities as judged by the investigator.
- Normal physical exam, blood pressure between 90/50 and 149/90 mm Hg, heart rate between 40 and 100 bpm, and body temperature 35.56C to 37.56C.
- Normal or not clinically significant lab results, including blood counts, liver tests (AST, ALT, bilirubin), ECG with QTcF 60; 450 msec for males and 60; 470 msec for females, and HbA1c within normal range.
- Willingness to refrain from smoking from 7 days before dosing to Day 12.
- Willingness to abstain from alcohol 48 hours before dosing and throughout the study.
- Female volunteers must be either nonchildbearing (surgically sterilized or postmenopausal) or if childbearing potential have negative pregnancy tests and agree to use adequate contraception.
- Male volunteers must agree not to donate sperm until 90 days after last dose and use adequate contraception if sexually active with female partners.
- Suitable venous access for blood sampling.
- Ability and willingness to comply with all study assessments and protocol requirements.
You will not qualify if you...
- History or presence of significant cardiovascular, pulmonary, liver, kidney, blood, gastrointestinal, endocrine, immune, skin, or neurological diseases.
- History of surgery or hospitalization within 30 days before screening or planned surgery during the study.
- Acute infections within 4 weeks before screening or current infections needing systemic antibiotics or antivirals.
- Any abnormality affecting drug absorption, distribution, metabolism, or elimination.
- History of cancer in last 5 years except certain skin cancers.
- Clinically relevant immunosuppression.
- Use of systemic immunosuppressive or immunomodulating drugs before or during the study.
- Use of medications or agents that interact with CYP3A4 or affect organ function prior to or during the study.
- History of risk factors for torsade de pointes or significant arrhythmia.
- Positive tests for HIV, hepatitis B or C at screening.
- Low kidney function (creatinine clearance <60 mL/min).
- Elevated creatine kinase (>2 x ULN) at Day -1.
- History of drug or alcohol abuse in past 2 years exceeding defined limits.
- Positive drug or alcohol tests at screening or Day -1.
- Use of prescription or over-the-counter drugs within 14 days or 5 half-lives before dosing except allowed medications.
- Significant allergic reactions interfering with study participation.
- Known allergy to study drug ingredients.
- Recent vaccinations within defined time frames except certain COVID-19 or influenza vaccines.
- Females who are breastfeeding or planning to breastfeed during the study.
- Recent blood or plasma donation or transfusions within specified time frames.
- Participation in another investigational drug study within 30 days or 5 half-lives before dosing.
- Any other condition making the volunteer unsuitable or likely to be noncompliant.
- History of long-COVID or severe influenza requiring hospitalization or disrupting daily activities for more than 7 days.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Scientia Clinical Research Ltd.
Randwick, New South Wales, Australia, 2031
Actively Recruiting
Research Team
E
Ekaterina Dokukina
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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