Healthy VolunteerPhase 1NCT07526506
Study of TRX-100 Evaluating the Safety, Pharmacokinetics, and Food Effect in Healthy Volunteers
A Phase 1 study testing TRX-100 in people with Healthy Volunteer, run by Traws Pharma, Inc. at 1 site in Australia.
Trial summary
This is a Phase 1b, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics, and food effect of single oral doses of TRX-100 tablets and capsules in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- TRX-100
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteAustralia
- Study dates
- 25 Mar 2026to Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
- No clinically significant findings in serum chemistry, hematology, coagulation, and urinalysis tests as judged by the Investigator, including the following specific findings:
- Haemoglobin, platelet count, WBC count, lymphocyte count, and neutrophil count within normal ranges (as per local laboratory standard ranges) or out-of-range values deemed not clinically significant (NCS) by the Investigator.
- AST, ALT and total bilirubin < 1.5 x ULN (note: for participants with Gilbert's syndrome, ULN for total bilirubin is considered to be 2.9 mg/dL).
- Triplicate 12-lead ECG (taken after the volunteer has been supine for at least 5 minutes) with a QTcF ≤ 450 msec for males and ≤ 470 msec for females and no clinically significant abnormalities.
- Hemoglobin A1C (HbA1c) level within the local laboratory standard reference range
- Be willing to refrain from smoking (including tobacco, nicotine replacement therapy, e-cigarettes) from 7 days prior to dose administration on Day 1 to Day 12 (inclusive).
- Be willing to abstain from alcohol consumption at least 48 hours prior to dosing on Day -1 and throughout the study.
- Female volunteers must:
- Be of nonchildbearing potential, i.e., surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy) at least 6 weeks before screening or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause and a follicle-stimulating hormone (FSH) level >40 IU/L at the screening visit), or
- If of childbearing potential, must:
- Have a negative pregnancy test at the screening visit and on admission to the clinic on Day-1.
- Agree not to attempt to become pregnant or donate ova from signing the consent form until at least 30 days after the last dose of the study drug.
- Agree to use adequate contraception (defined as use of a condom by the male partner combined with use of a highly effective method of contraception) from one month prior to screening until at least 30 days after the last dose of study drug, if not exclusively in a same-sex relationship or abstinent as a committed lifestyle.
- Male volunteers must:
- Agree not to donate sperm from signing the consent form until at least 90 days after the last dose of study drug.
- If engaging in sexual intercourse with a female partner who could become pregnant, agree to use adequate contraception (defined as use of a condom combined with use of a highly effective method of contraception) from signing the consent form until at least 30 days after the last dose of study drug.
- Have suitable venous access for blood sampling.
- Be willing and able to comply with all study assessments and adhere to the protocol.
Who cannot join
- 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.
- 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.
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- 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.
- History of risk factors for torsade de pointes (including a family history of long QT syndrome or sudden cardiac death) or clinically significant arrythmia.
- 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 < 60 mL/min using the Cockcroft-Gault formula at the screening visit.
- Creatine kinase >2 x ULN at Day -1.
- History of any drug or alcohol abuse in the past 2 years defined as >21 units of alcohol per week for males and >14 units of alcohol per week for females. Where 1 unit = 360 mL of beer, 150 mL wine, or 30 mL of spirits.
- Positive drugs of abuse or alcohol breath test results at the screening visit or on Day -1.
- Use of any prescription medications or any over-the-counter medication (including herbal products, nutritional, calcium-enriched dietary supplements, antacids, laxatives, minerals and hormone supplements) within 14 days or at least 5 half-lives of the medication (whichever is longer) prior to the first study drug administration and during the study, with the exception of oral, injectable and implanted contraceptives, occasional use of paracetamol (doses of 500 mg up to every 6 hours or 2 g per day maximum for no more than 3 consecutive days) or ibuprofen (doses of 400 mg up to every 6 hours or 1.2 g per day maximum for no more than 3 consecutive days), topical ointments, vitamins, dietary supplements and medications used to manage AEs.
- Demonstrated clinically significant (required intervention, e.g., emergency room visit, epinephrine administration) allergic reactions (e.g., food, drug, or atopic reactions, asthmatic episodes) which, in the opinion of the Investigator, would interfere with the volunteer's ability to participate in the trial.
- 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. Note: Participants vaccinated for COVID-19 or influenza within at least 2 weeks prior to dosing or earlier will be considered eligible for enrolment as long as they do not present with post-vaccination clinical symptoms, have a negative rapid antigen test (in the case of COVID-19), and are deemed otherwise healthy.
- 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, or loss of whole blood of more than 500 mL within 30 days prior to first study drug administration, or receipt of a blood transfusion within 1 year of first study drug administration.
- Receiving an investigational drug in another clinical trial within 30 days or 5 half-lives of the investigational agent (whichever is longer) prior to the first study drug administration.
- Any other condition or prior therapy that in the opinion of the Investigator would make the volunteer unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.
- Any history of long-COVID infection (defined by continuation or development of new symptoms 3 months after the initial SARS-CoV-2 infection, with these symptoms lasting for at least 2 months with no other explanation).
- Any history of severe influenza, defined as a confirmed diagnosis of influenza resulting in hospitalization, or symptoms severe enough to disrupt daily activities for more than 7 consecutive days.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Scientia Clinical Research Ltd.
Randwick, New South Wales, 2031
Christopher Argent, Dr., 02 9382 5844, christopher.argent@scientiaclinicalresearch.com.au
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of TRX-100 Evaluating the Safety, Pharmacokinetics, and Food Effect of Single Ascending Doses of TRX-100 in Healthy Volunteers
This is a Phase 1b, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics, and food effect of single oral doses of TRX-100 tablets and capsules in healthy adult volunteers. Up to 32 participants will be enrolled in four cohorts and randomized within each cohort to receive TRX-100 or matching placebo.
Read the detailed description
This is a Phase 1b, randomized, double-blind, placebo-controlled, dose-escalation study of single oral doses of TRX-100 tablets and capsules in healthy male and female volunteers 18 to 65 years of age. The study evaluates safety, tolerability, the pharmacokinetics of TRX-100 and its active metabolite TRX-101, and the effect of food on pharmacokinetics.
Up to 32 participants will be enrolled in four cohorts of 8 participants each. Within each cohort, participants will be randomized 6:2 to receive TRX-100 or matching placebo. Cohort A will receive 240 mg TRX-100 tablets or matching placebo under fed conditions. Cohort B will receive 480 mg TRX-100 tablets or matching placebo under fasted conditions. Cohort C will receive 480 mg TRX-100 tablets or matching placebo under fed conditions. Cohort D will receive 480 mg TRX-100 capsules or matching placebo under fed conditions.
Cohorts A and B may be dosed in parallel. Cohort C will begin only after the Safety Review Committee has reviewed available blinded safety data and initial pharmacokinetic data from Cohort A and confirmed that exposure levels are acceptable. Cohort D will begin after completion of Cohort C.
Participants will be confined at the clinical facility from Day -1 through Day 4 and will return for outpatient safety and pharmacokinetic assessments through the end-of-study visit on Day 28 (±2 days). The food effect at 480 mg will be evaluated primarily by comparing Cohort B under fasted conditions with Cohort C under fed conditions; data from Cohort D under fed conditions will also be used.
- Conditions
- Healthy Volunteer
- Being tested
- TRX-100, Placebo
- Keywords
- Influenza, Flu, TRX-100, Cap-dependent endonuclease inhibitor, Food effect, Healthy volunteers
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRX-100Drug
TRX-100 will be administered as a single oral dose on Day 1 with approximately 240 mL of noncarbonated room-temperature water. Active treatment is administered as 240 mg tablets in Cohort A, 480 mg tablets in Cohorts B and C, and 480 mg capsules in Cohort D. Study drug must be swallowed whole and must not be chewed, divided, dissolved, or crushed.
PlaceboDrug
Matching tablet or capsule placebo will be administered as a single oral dose on Day 1 under the same meal and administration conditions as the corresponding active-treatment cohort.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: 240 mg tablets, fed | Experimental | Up to 8 healthy volunteers will be randomized 6:2 to receive a single oral dose of TRX-100 240 mg tablets or matching tablet placebo, respectively, under fed conditions. Receives: Drug: TRX-100; Drug: Placebo |
| Cohort B: 480 mg tablets, fasted | Experimental | Up to 8 healthy volunteers will be randomized 6:2 to receive a single oral dose of TRX-100 480 mg tablets or matching tablet placebo, respectively, under fasted conditions. Receives: Drug: TRX-100; Drug: Placebo |
| Cohort C: 480 mg tablets, fed | Experimental | Up to 8 healthy volunteers will be randomized 6:2 to receive a single oral dose of TRX-100 480 mg tablets or matching tablet placebo, respectively, under fed conditions. Dosing will begin only after Safety Review Committee review of available blinded safety data and initial pharmacokinetic data from Cohort A. Receives: Drug: TRX-100; Drug: Placebo |
| Cohort D: 480 mg capsules, fed | Experimental | Up to 8 healthy volunteers will be randomized 6:2 to receive a single oral dose of TRX-100 480 mg capsules or matching capsule placebo, respectively, under fed conditions. Dosing will begin after completion of Cohort C. Receives: Drug: TRX-100; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, severity, and relationship of treatment-emergent adverse events
Number and percentage of participants with treatment-emergent adverse events, summarized by severity and relationship to study drug.
Measured: From administration of study drug on Day 1 through the end-of-study visit on Day 28 (±2 days).
Incidence of serious adverse events and adverse events leading to discontinuation
Number and percentage of participants with serious adverse events and adverse events leading to discontinuation from the study.
Measured: From administration of study drug on Day 1 through the end-of-study visit on Day 28 (±2 days).
Secondary outcomes (10)
Maximum observed plasma concentration (Cmax) of TRX-100 and TRX-101
Maximum observed plasma concentration of TRX-100 and its active metabolite TRX-101.
Measured: Predose through Day 28 (648 hours post-dose; ±2 days).
Time to maximum observed plasma concentration (Tmax) of TRX-100 and TRX-101
Time to reach the maximum observed plasma concentration of TRX-100 and TRX-101.
Measured: Predose through Day 28 (648 hours post-dose; ±2 days).
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC0-last)
AUC0-last of TRX-100 and TRX-101.
Measured: Predose through Day 28 (648 hours post-dose; ±2 days).
Area under the plasma concentration-time curve from time 0 to 24 hours (AUC0-24)
AUC0-24 of TRX-100 and TRX-101.
Measured: Predose through 24 hours post-dose.
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf)
AUC0-inf of TRX-100 and TRX-101.
Measured: Predose through Day 28 (648 hours post-dose; ±2 days).
Apparent terminal elimination half-life (t1/2) of TRX-100 and TRX-101
Apparent terminal elimination half-life of TRX-100 and TRX-101.
Measured: Predose through Day 28 (648 hours post-dose; ±2 days).
Total apparent body clearance following oral administration (CL/F)
Total apparent body clearance following oral administration of TRX-100, calculated when data permit.
Measured: Predose through Day 28 (648 hours post-dose; ±2 days).
Apparent volume of distribution following oral administration (Vz/F)
Apparent volume of distribution following oral administration of TRX-100, calculated when data permit.
Measured: Predose through Day 28 (648 hours post-dose; ±2 days).
Effect of food on exposure to TRX-100 and TRX-101
Geometric mean ratios for fed versus fasted conditions and corresponding 90% confidence intervals for Cmax, AUC0-last, AUC0-inf, and AUC0-24 of TRX-100 and TRX-101. The primary comparison is Cohort B (480 mg tablets, fasted) versus Cohort C (480 mg tablets, fed); data from Cohort D (480 mg capsules, fed) will also be used.
Measured: Predose through Day 28 (648 hours post-dose; ±2 days).
Effect of food on Tmax and other pharmacokinetic parameters of TRX-100 and TRX-101
Descriptive comparison of Tmax and other pharmacokinetic parameters of TRX-100 and TRX-101 by fed and fasted conditions.
Measured: Predose through Day 28 (648 hours post-dose; ±2 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start25 Mar 2026
- Primary completionSep 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Four cohorts evaluate two dose levels, two formulations, and fed or fasted administration. Cohorts A and B may be dosed in parallel. Cohort C begins after Safety Review Committee review of Cohort A data, and Cohort D begins after completion of Cohort C.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Traws Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07526506
- Sponsor's protocol ID
- TRX-100-0003
- Status last verified
- Jul 2026
- First submitted
- 6 Apr 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of TRX-100 Evaluating the Safety, Pharmacokinetics, and Food Effect of Single Ascending Doses of TRX-100 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07526506
- Acronym / sponsor ID
- TRX-100-0003
- Conditions
- Healthy Volunteer
- Keywords
- Influenza, Flu, TRX-100, Cap-dependent endonuclease inhibitor, Food effect, Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Traws Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Mar 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1b, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics, and food effect of single oral doses of TRX-100 tablets and capsules in healthy adult volunteers. Up to 32 participants will be enrolled in four cohorts and randomized within each cohort to receive TRX-100 or matching placebo.
Detailed description
This is a Phase 1b, randomized, double-blind, placebo-controlled, dose-escalation study of single oral doses of TRX-100 tablets and capsules in healthy male and female volunteers 18 to 65 years of age. The study evaluates safety, tolerability, the pharmacokinetics of TRX-100 and its active metabolite TRX-101, and the effect of food on pharmacokinetics.
Up to 32 participants will be enrolled in four cohorts of 8 participants each. Within each cohort, participants will be randomized 6:2 to receive TRX-100 or matching placebo. Cohort A will receive 240 mg TRX-100 tablets or matching placebo under fed conditions. Cohort B will receive 480 mg TRX-100 tablets or matching placebo under fasted conditions. Cohort C will receive 480 mg TRX-100 tablets or matching placebo under fed conditions. Cohort D will receive 480 mg TRX-100 capsules or matching placebo under fed conditions.
Cohorts A and B may be dosed in parallel. Cohort C will begin only after the Safety Review Committee has reviewed available blinded safety data and initial pharmacokinetic data from Cohort A and confirmed that exposure levels are acceptable. Cohort D will begin after completion of Cohort C.
Participants will be confined at the clinical facility from Day -1 through Day 4 and will return for outpatient safety and pharmacokinetic assessments through the end-of-study visit on Day 28 (±2 days). The food effect at 480 mg will be evaluated primarily by comparing Cohort B under fasted conditions with Cohort C under fed conditions; data from Cohort D under fed conditions will also be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Four cohorts evaluate two dose levels, two formulations, and fed or fasted administration. Cohorts A and B may be dosed in parallel. Cohort C begins after Safety Review Committee review of Cohort A data, and Cohort D begins after completion of Cohort C.
| Arm | Type | Receives |
|---|---|---|
| Cohort A: 240 mg tablets, fed | Experimental | Drug: TRX-100, Drug: PlaceboUp to 8 healthy volunteers will be randomized 6:2 to receive a single oral dose of TRX-100 240 mg tablets or matching tablet placebo, respectively, under fed conditions. |
| Cohort B: 480 mg tablets, fasted | Experimental | Drug: TRX-100, Drug: PlaceboUp to 8 healthy volunteers will be randomized 6:2 to receive a single oral dose of TRX-100 480 mg tablets or matching tablet placebo, respectively, under fasted conditions. |
| Cohort C: 480 mg tablets, fed | Experimental | Drug: TRX-100, Drug: PlaceboUp to 8 healthy volunteers will be randomized 6:2 to receive a single oral dose of TRX-100 480 mg tablets or matching tablet placebo, respectively, under fed conditions. Dosing will begin only after Safety Review Committee review of available blinded safety data and initial pharmacokinetic data from Cohort A. |
| Cohort D: 480 mg capsules, fed | Experimental | Drug: TRX-100, Drug: PlaceboUp to 8 healthy volunteers will be randomized 6:2 to receive a single oral dose of TRX-100 480 mg capsules or matching capsule placebo, respectively, under fed conditions. Dosing will begin after completion of Cohort C. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- 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:
- Be willing to refrain from smoking (including tobacco, nicotine replacement therapy, e-cigarettes) from 7 days prior to dose administration on Day 1 to Day 12 (inclusive).
Key exclusion criteria (24 listed)
- 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.
- Any history of malignant disease in the last 5 years (excludes surgically resected skin squamous cell or basal cell carcinoma).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRX-100TRX-100 will be administered as a single oral dose on Day 1 with approximately 240 mL of noncarbonated room-temperature water. Active treatment is administered as 240 mg tablets in Cohort A, 480 mg tablets in Cohorts B and C, and 480 mg capsules in Cohort D. Study drug must be swallowed whole and must not be chewed, divided, dissolved, or crushed. | Drug | Cohort A: 240 mg tablets, fed, Cohort B: 480 mg tablets, fasted, Cohort C: 480 mg tablets, fed, Cohort D: 480 mg capsules, fed |
| PlaceboMatching tablet or capsule placebo will be administered as a single oral dose on Day 1 under the same meal and administration conditions as the corresponding active-treatment cohort. | Drug | Cohort A: 240 mg tablets, fed, Cohort B: 480 mg tablets, fasted, Cohort C: 480 mg tablets, fed, Cohort D: 480 mg capsules, fed |
Primary outcome
Incidence, severity, and relationship of treatment-emergent adverse events
Time frame: From administration of study drug on Day 1 through the end-of-study visit on Day 28 (±2 days).
Number and percentage of participants with treatment-emergent adverse events, summarized by severity and relationship to study drug.
Incidence of serious adverse events and adverse events leading to discontinuation
Time frame: From administration of study drug on Day 1 through the end-of-study visit on Day 28 (±2 days).
Number and percentage of participants with serious adverse events and adverse events leading to discontinuation from the study.
10 secondary outcomes
Maximum observed plasma concentration (Cmax) of TRX-100 and TRX-101
Time frame: Predose through Day 28 (648 hours post-dose; ±2 days).
Time to maximum observed plasma concentration (Tmax) of TRX-100 and TRX-101
Time frame: Predose through Day 28 (648 hours post-dose; ±2 days).
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC0-last)
Time frame: Predose through Day 28 (648 hours post-dose; ±2 days).
Area under the plasma concentration-time curve from time 0 to 24 hours (AUC0-24)
Time frame: Predose through 24 hours post-dose.
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf)
Time frame: Predose through Day 28 (648 hours post-dose; ±2 days).
Apparent terminal elimination half-life (t1/2) of TRX-100 and TRX-101
Time frame: Predose through Day 28 (648 hours post-dose; ±2 days).
Total apparent body clearance following oral administration (CL/F)
Time frame: Predose through Day 28 (648 hours post-dose; ±2 days).
Apparent volume of distribution following oral administration (Vz/F)
Time frame: Predose through Day 28 (648 hours post-dose; ±2 days).
Effect of food on exposure to TRX-100 and TRX-101
Time frame: Predose through Day 28 (648 hours post-dose; ±2 days).
Effect of food on Tmax and other pharmacokinetic parameters of TRX-100 and TRX-101
Time frame: Predose through Day 28 (648 hours post-dose; ±2 days).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TRX-100 in people with Healthy Volunteer, run by Traws Pharma, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ekaterina Dokukina (+1 858 353 4108, kdokukina@eilenther.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, severity, and relationship of treatment-emergent adverse events (time frame: From administration of study drug on Day 1 through the end-of-study visit on Day 28 (±2 days).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.