Evaluating the safety and effects of a new drug in healthy volunteers

A Randomised, Double-Blind, Placebo-Controlled, First-in-Human Study of Orally Administered 83-0060 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of 83-0060 in Healthy Volunteers

This study is testing a new drug in healthy volunteers to see if it's safe and how it works in the body.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Traws Pharma, Inc. (Industry-sponsored)
• Locations: 1 site (Sydney, Greater Sydney Area)
• Trial ID: NCT06402136 on ClinicalTrials.gov

What this trial studies

This clinical study is designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of a new drug, 83-0060, in healthy volunteers. It is a Phase 1, double-blind, placebo-controlled trial that will involve two parts: a single ascending dose (SAD) and a multiple ascending dose (MAD), with participants receiving varying doses of the drug. The study will evaluate the effects of the drug in a sequential manner, starting with lower doses and progressing to higher ones, to ensure safety and efficacy.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18 to 65 with a BMI between 18.5 and 32.0 kg/m2.

Not a fit: Patients with significant underlying health conditions or recent surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable information on the safety and dosing of 83-0060, paving the way for future studies in patients.

How similar studies have performed: Other studies involving similar dose escalation and safety assessments have shown success, indicating that this approach is well-established.

Eligibility criteria

Inclusion Criteria:

1. 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.
2. Adult males and females, 18 to 65 years of age (inclusive) at screening.
3. Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2, with a body weight (to 1 decimal place) ≥ 50.0 kg at screening.

Exclusion Criteria:

1. 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.
2. History of surgery or hospitalisation within 30 days prior to screening, or surgery planned during the study.
3. Acute infections within 4 weeks prior to screening or current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medications.
4. 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.
5. Any history of malignant disease in the last 5 years (excludes surgically resected skin squamous cell or basal cell carcinoma).
6. Any screening laboratory result outside the normal laboratory reference range (as confirmed upon repeated testing) and deemed clinically significant by the PI.

Where this trial is running

Sydney, Greater Sydney Area

• Scientia Clinical Research — Sydney, Greater Sydney Area, Australia (Recruiting)

Study contacts

• Study coordinator: Ekaterina Dokukina, MD, MPHIL

Conditions Healthy Volunteers Only