Healthy Volunteer StudyPhase 1NCT06757738
A Clinical Study Aiming to Assess Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of TRX-100 in Healthy Volunteers
A Phase 1 study testing TRX-100 in people with Healthy Volunteer Study, run by Traws Pharma, Inc. at 1 site in Australia.
Trial summary
This is a clinical study aiming to assess pharmacokinetics, pharmacodynamics and preliminary efficacy of TRX-100 (and its major active metabolite TRX-101) in Healthy Volunteers Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer Study
- 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
- 66 participants
- Where
- 1 siteAustralia
- Study dates
- 13 Aug 2024to 24 Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 64 years
- All sexes
- Healthy volunteers accepted
- 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 64 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 and prior to dosing at the timepoints indicated in the SoA, 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
- 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.
- Triplicate 12-lead ECG (taken after the volunteer has been supine or semi-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) levels within the local laboratory standard reference range.
- Be willing to not smoke (including tobacco, nicotine replacement therapy, e-cigarettes) from 7 days prior to dose administration on Day 1 to Day 12 (inclusive) for all cohorts. For optional Cohort 4 only, participants must also be willing to not smoke (including tobacco, nicotine replacement therapy, e-cigarettes) from 7 days prior to dose administration on Day 28 to Day 39 (inclusive) .
- Female volunteers must:
- Be of nonchildbearing potential i.e., surgically sterilized (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 if under the age of 55 years a follicle-stimulating hormone (FSH) level >40 IU/L at the screening visit), or
- If of childbearing potential, must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use an acceptable method of contraception from signing the consent form until at least 30 days after the last dose of the study drug.
- Male volunteers, if not surgically sterilized, must agree to:
- Not donate sperm after signing consent, during the study, and at least 90 days after the EoS visit.
- If engaging in sexual intercourse with a female partner who could become pregnant, must agree to use an acceptable method of contraception from signing the consent form until at least 90 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 schedule and restrictions.
Who cannot join
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, 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.
- 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, 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).
- Any screening laboratory result outside the normal laboratory reference range (as confirmed upon repeated testing) and deemed clinically significant by the PI.
- 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 or within 5 half-lives of individual agent or within 28 days (whichever is longer) prior to Screening.
- 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 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.
- Participant is planning to have surgery between Screening and the EoS visit.
- 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.
- Presence or having sequelae of gastrointestinal, liver, kidney, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- Estimated creatinine clearance < 60 mL/min using the Cockcroft-Gault formula.
- Creatine kinase >2.0 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.
- History of alcohol consumption in the 48 hrs prior to dosing.
- Positive drugs of abuse, or alcohol breath test results at the screening visit or at check-in (Day -1).
- Use of any prescription medications within 14 days or at least 5 half-lives of the medication (whichever is longer) prior to the first study drug administration, including use of any over-the-counter medication (including herbal products, nutritional, diet aids, vitamin supplements, minerals) within 7 days or at least 5 half-lives of the medication (whichever is longer) prior to the first study drug administration, with the exception of the 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, and vitamins or 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. Note: Participants vaccinated for COVID-19 or influenza within at least 2 weeks prior to enrollment or earlier will be considered eligible for enrollment 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.
- For women of childbearing potential, a positive serum pregnancy test at the screening visit or a positive urine pregnancy test (with confirmatory serum pregnancy test) at check-in (Day -1).
- 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 Investigators 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.
Australia1 site
Scientia Clinical Research
Sydney, Greater Sydney Area, NSW 2031
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 1, Dose Escalation (With Optional Food Effect) Study of Orally Administered TRX-100 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of TRX-100 in Healthy Volunteers
This is a clinical study aiming to assess pharmacokinetics, pharmacodynamics and preliminary efficacy of TRX-100 (and its major active metabolite TRX-101) in Healthy Volunteers
Read the detailed description
This is a Phase 1, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, PK, PD of orally administered TRX-100 (and its major active metabolite TRX-101) in Healthy Volunteers. The study will be conducted in 1 part only, as a single ascending dose (SAD) study at up to 4 dose levels. Evaluation of dose levels will be conducted in a sequential fashion with lower dose levels evaluated first in the sequence.
- Conditions
- Healthy Volunteer Study
- Being tested
- TRX-100, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRX-100Drug
CEN inhibitor, dosage form - capsules, dosing regimen - QD
PlaceboDrug
Placebo, dosage form - capsules, dosing regimen - QD
| Study group | Role | What they receive |
|---|---|---|
| Single dose level 1 or placebo | Experimental | SAD dose level 1 Receives: Drug: TRX-100; Drug: Placebo |
| Single dose level 2 or placebo | Experimental | SAD dose level 2 Receives: Drug: TRX-100; Drug: Placebo |
| Single dose level 3 or placebo | Experimental | SAD dose level 3 Receives: Drug: TRX-100; Drug: Placebo |
| Single dose level 4 or placebo | Experimental | SAD dose level 4 Receives: Drug: TRX-100; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of a single oral administration of TRX-100
Incidence, severity and relationship of AEs/serious AEs (SAEs) (including withdrawals due to AEs)
Measured: up to Day 28
To assess the safety and tolerability of a single oral administration of TRX-100
Change from baseline in body weight in kg
Measured: up to Day 28
To assess the safety and tolerability of a single oral administration of TRX-100
Change from baseline in systolic and diastolic blood pressure (mm Hg)
Measured: up to Day 28
To assess the safety and tolerability of a single oral administration of TRX-100
Change from baseline in QRS duration (miliseconds)
Measured: up to Day 28
To assess the safety and tolerability of a single oral administration of TRX-100
Change from baseline in heart rate (beats per minute)
Measured: up to Day 28
To assess the safety and tolerability of a single oral administration of TRX-100
Change from baseline in body temperature (Celsius)
Measured: up to Day 28
To assess the safety and tolerability of a single oral administration of TRX-100 a
Change from baseline in QT interval (miliseconds)
Measured: up to Day 28
Secondary outcomes (7)
To measure the pharmacokinetics of TRX-100 and its active metabolite TRX-101 in plasma
Maximum observed concentration (Cmax)
Measured: up to Day 28
To measure the pharmacokinetics of TRX-100 and its active metabolite TRX-101 in plasma
Time to Cmax (Tmax)
Measured: up to Day 28
To measure the pharmacokinetics of TRX-100 and its active metabolite TRX-101 in plasma
Area under the concentration-time curve from 0 to time of last quantifiable concentration (AUC0-last)
Measured: up to Day 28
To measure the pharmacokinetics of TRX-100 and its active metabolite TRX-101 in plasma
Area under the concentration-time curve from 0 to 24 hours (AUC0-24)
Measured: up to Day 28
To measure the pharmacokinetics of TRX-100 and its active metabolite TRX-101 in plasma
Area under the concentration-time curve from 0 to infinity (AUC0-inf)
Measured: up to Day 28
To measure the pharmacokinetics of TRX-100 and its active metabolite TRX-101 in plasma
Apparent terminal elimination half-life (t1/2)
Measured: up to Day 28
To measure the pharmacokinetics of TRX-100 and its active metabolite TRX-101 in plasma
Terminal elimination rate constant (λz)
Measured: up to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start13 Aug 2024
- Primary completion16 Jan 2025
- Study completion24 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteer StudyStudies 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
- Participants will be randomized into 4 cohorts (8 participant per cohort) to receive study drug
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Traws Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06757738
- Sponsor's protocol ID
- TRX-100-0001
- Other IDs
- CT-2024-CTN-03164
- Status last verified
- Jan 2026
- First submitted
- 16 Dec 2024
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Phase 1, Dose Escalation (With Optional Food Effect) Study of Orally Administered TRX-100 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of TRX-100 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06757738
- Acronym / sponsor ID
- TRX-100-0001
- Conditions
- Healthy Volunteer Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Traws Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Aug 2024 (actual)
- Primary completion
- 16 Jan 2025 (actual)
- Study completion
- 24 Jan 2025 (actual)
- First posted
- 3 Jan 2025 (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 clinical study aiming to assess pharmacokinetics, pharmacodynamics and preliminary efficacy of TRX-100 (and its major active metabolite TRX-101) in Healthy Volunteers
Detailed description
This is a Phase 1, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, PK, PD of orally administered TRX-100 (and its major active metabolite TRX-101) in Healthy Volunteers. The study will be conducted in 1 part only, as a single ascending dose (SAD) study at up to 4 dose levels. Evaluation of dose levels will be conducted in a sequential fashion with lower dose levels evaluated first in the sequence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Participants will be randomized into 4 cohorts (8 participant per cohort) to receive study drug
| Arm | Type | Receives |
|---|---|---|
| Single dose level 1 or placebo | Experimental | Drug: TRX-100, Drug: PlaceboSAD dose level 1 |
| Single dose level 2 or placebo | Experimental | Drug: TRX-100, Drug: PlaceboSAD dose level 2 |
| Single dose level 3 or placebo | Experimental | Drug: TRX-100, Drug: PlaceboSAD dose level 3 |
| Single dose level 4 or placebo | Experimental | Drug: TRX-100, Drug: PlaceboSAD dose level 4 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 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 64 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 and prior to dosing at the timepoints indicated in the SoA, including:
- Be willing to not smoke (including tobacco, nicotine replacement therapy, e-cigarettes) from 7 days prior to dose administration on Day 1 to Day 12 (inclusive) for all cohorts. For optional Cohort 4 only, participants must also be willing to not smoke (including tobacco, nicotine replacement therapy, e-cigarettes) from 7 days prior to dose administration on Day 28 to Day 39 (inclusive) .
Key exclusion criteria (28 listed)
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, 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.
- 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, 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).
- Any screening laboratory result outside the normal laboratory reference range (as confirmed upon repeated testing) and deemed clinically significant by the PI.
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-100CEN inhibitor, dosage form - capsules, dosing regimen - QD | Drug | Single dose level 1 or placebo, Single dose level 2 or placebo, Single dose level 3 or placebo, Single dose level 4 or placebo |
| PlaceboPlacebo, dosage form - capsules, dosing regimen - QD | Drug | Single dose level 1 or placebo, Single dose level 2 or placebo, Single dose level 3 or placebo, Single dose level 4 or placebo |
Primary outcome
To assess the safety and tolerability of a single oral administration of TRX-100
Time frame: up to Day 28
Incidence, severity and relationship of AEs/serious AEs (SAEs) (including withdrawals due to AEs)
To assess the safety and tolerability of a single oral administration of TRX-100
Time frame: up to Day 28
Change from baseline in body weight in kg
To assess the safety and tolerability of a single oral administration of TRX-100
Time frame: up to Day 28
Change from baseline in systolic and diastolic blood pressure (mm Hg)
To assess the safety and tolerability of a single oral administration of TRX-100
Time frame: up to Day 28
Change from baseline in QRS duration (miliseconds)
To assess the safety and tolerability of a single oral administration of TRX-100
Time frame: up to Day 28
Change from baseline in heart rate (beats per minute)
To assess the safety and tolerability of a single oral administration of TRX-100
Time frame: up to Day 28
Change from baseline in body temperature (Celsius)
To assess the safety and tolerability of a single oral administration of TRX-100 a
Time frame: up to Day 28
Change from baseline in QT interval (miliseconds)
7 secondary outcomes
To measure the pharmacokinetics of TRX-100 and its active metabolite TRX-101 in plasma
Time frame: up to Day 28
To measure the pharmacokinetics of TRX-100 and its active metabolite TRX-101 in plasma
Time frame: up to Day 28
To measure the pharmacokinetics of TRX-100 and its active metabolite TRX-101 in plasma
Time frame: up to Day 28
To measure the pharmacokinetics of TRX-100 and its active metabolite TRX-101 in plasma
Time frame: up to Day 28
To measure the pharmacokinetics of TRX-100 and its active metabolite TRX-101 in plasma
Time frame: up to Day 28
To measure the pharmacokinetics of TRX-100 and its active metabolite TRX-101 in plasma
Time frame: up to Day 28
To measure the pharmacokinetics of TRX-100 and its active metabolite TRX-101 in plasma
Time frame: up to Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Study, 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 20 inclusion and 28 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: finished, as of the sponsor's last update on 21 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety and tolerability of a single oral administration of TRX-100 (time frame: up to Day 28). The study lists 7 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 21 Jan 2026.