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

Traws Pharma, Inc.1 site in 1 country66 target enrollmentAugust 13, 2024

ConditionsHealthy Volunteer Study

InterventionsPlacebo TRX-100

DrugsTRX-100 Placebo

Overview

Phase: Phase 1
Intervention: Placebo
Conditions: Healthy Volunteer Study
Sponsor: Traws Pharma, Inc.
Enrollment: 66
Locations: 1
Primary Endpoint: To assess the safety and tolerability of a single oral administration of TRX-100
Status: Completed
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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

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.

Registry

clinicaltrials.gov

Start Date

August 13, 2024

End Date

January 24, 2025

Last Updated

3 months ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Traws Pharma, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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
•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.

Exclusion Criteria

•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.
•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.