Study of TRX-100 Evaluating the Safety, Pharmacokinetics, and Food Effect in Healthy Volunteers

NCT07526506 | Recruiting Phase 1

• 1 other identifier: TRX-100-0003
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. Up to 32 participants will be enrolled in four cohorts and randomized within each cohort to receive TRX-100 or matching placebo.

Conditions

Healthy Volunteer

Keywords

Influenza; Flu; TRX-100; Cap-dependent endonuclease inhibitor; Food effect; Healthy volunteers

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  Predose through Day 28 (648 hours post-dose; ±2 days).

• Time to maximum observed plasma concentration (Tmax) of TRX-100 and TRX-101

  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)

  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)

  Predose through 24 hours post-dose.

• Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf)

  Predose through Day 28 (648 hours post-dose; ±2 days).

Study Arms (4)

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.

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.

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.

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.

Drug: TRX-100; Drug: Placebo

Interventions

TRX-100 DRUG

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.

Cohort A: 240 mg tablets, fed; Cohort B: 480 mg tablets, fasted; Cohort C: 480 mg tablets, fed; Cohort D: 480 mg capsules, fed

Placebo DRUG

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.

Cohort A: 240 mg tablets, fed; Cohort B: 480 mg tablets, fasted; Cohort C: 480 mg tablets, fed; Cohort D: 480 mg capsules, fed

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• No clinically significant findings in serum chemistry, hematology, coagulation, and urinalysis tests as judged by the Investigator, including the following specific findings:
• i. 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.
• ii. 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).
• iii. 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.
• iv. 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Traws Pharma, Inc.: lead

Study Sites (1)

Scientia Clinical Research Ltd.

Randwick, New South Wales, 2031, Australia

RECRUITING

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Central Study Contacts

Ekaterina Dokukina

CONTACT

+1 858 353 4108; kdokukina@eilenther.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 13, 2026
• Study Start: March 25, 2026
• Primary Completion: September 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)