Not Yet RecruitingPhase 1ACTRN12626000272392

A 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

Sponsor

Traws Pharma, Inc

Enrollment

16 participants

Start Date

Apr 8, 2026

Study Type

Interventional

Conditions

Influenza

Summary

This is a Phase 1b, randomized, double-blind, placebo-controlled, dose escalation study of TRX-100 tablets evaluating the safety, pharmacokinetics (PK), and food effect of single ascending doses of TRX-100 in healthy volunteers. Participants will be enrolled in two cohorts evaluating two dose levels. Each cohort will use a two period design to assess the effect of food (fed vs fasted conditions) on the PK of TRX-100. A total of up to 16 healthy volunteers are planned to be enrolled across 2 cohorts.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Inclusion Criteria11

Participants must:
Be aged 18-65 (inclusive) years.
Signed the informed consent form (ICF).
Have a body mass index in the range of 18.5 to 32 kg/m2, with a body weight of 50kg or more at screening.
Medically healthy without clinically significant abnormalities (in the opinion of the Investigator).
Be willing to refrain from smoking from 7 days prior to dose administration.
Be willing to abstain from alcohol consumption 48 hours prior to dose administration.
Female participants and capable of becoming pregnant, have a negative pregnancy test at Screening and must agree to use a highly effective method of contraception from one month prior to screening till 30 days after last dose of study drug.
Male participants and of reproductive potential with sexual partner(s) of childbearing potential, must agree to use a highly effective form of birth control from signing of consent form and till 30 days after last dose of study drug.
Have suitable venous access for blood sampling.
Be able and willing to comply with all study assessments and adhere to the protocol.

Exclusion Criteria24

Participants must not:
Have history or presence of clinically 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.
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.
Any history of malignant disease in the last 5 years.
Presence of clinically relevant immunosuppression.
Use of or plans to use systemic immunosuppressive or immunomodulating medications during the study or prior to dosing.
History of risk factors for torsade de pointes or clinically significant arrythmia.
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 or within 7 days prior to dosing.
Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies at the screening visit.
Estimated creatinine clearance lesser than 60 mL/min at the screening visit.
History of any drug or alcohol abuse in the past 2 years defined as more than 21 units of alcohol per week for males and more than 14 units of alcohol per week for females.
Positive drugs of abuse or alcohol breath test results at the screening visit or on Day -1.
Creatine kinase greater than 1.5 times the upper normal limit at Day -1.
Use of any prescription medications or any over-the-counter medication within 14 days prior to dosing and during the study, with the exception of oral, injectable and implanted contraceptives, occasional use of paracetamol or ibuprofen, topical ointments, vitamins, dietary supplements and medications used to manage AEs.
Demonstrated clinically significant allergic reactions.
Known hypersensitivity to any of the study drug ingredients.
Use of any inactivated vaccinations within 14 days, or any live vaccinations within 30 days prior to the first study drug administration and during the study.
Females who are breastfeeding or planning to breast feed at any time during the study.
Donation of blood or plasma within 30 days prior to first study drug administration.
Receiving an investigational drug in another clinical trial within 30 days prior to dosing.
Any other condition or prior therapy that in the opinion of the Investigator would make the volunteer unsuitable for this study.
Any history of long-COVID infection.
Any history of severe influenza, having symptoms severe enough to disrupt daily activities for more than 7 consecutive days.

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Interventions

The study drug is TRX-100 oral tablets. There are 2 cohorts in the study: - Cohort A: 8 participants will receive one dose of either TRX-100 240 mg or matching placebo under fed conditions followed b

The study drug is TRX-100 oral tablets. There are 2 cohorts in the study: - Cohort A: 8 participants will receive one dose of either TRX-100 240 mg or matching placebo under fed conditions followed by one dose under fasted conditions with a 28 day washout period in between. For fed conditions, participants will be provided a high fat high calorie breakfast consisting of two fried eggs, two rashers of bacon, two slices of toast with butter, two hash browns and 1 cup of full cream milk. For fasted condition, participants will be required to fast overnight for 10 hours. - Cohort B: 8 participants will receive one dose of either TRX-100 480 mg or matching placebo under fed conditions followed by one dose under fasted conditions with a 28 day washout period in between. For fed conditions, participants will be provided a high fat high calorie breakfast consisting of two fried eggs, two rashers of bacon, two slices of toast with butter, two hash browns and 1 cup of full cream milk. For fasted condition, participants will be required to fast overnight for 10 hours. Proceeding to Cohort B will be dependent on Safety review committee's (SRC) review of safety and PK data of previous Cohort. Participants will be dosed as in-patients and adherence will be monitored by site staff.