Evaluation Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of 83-0060 in Healthy Volunteers

Launched by TRAWS PHARMA, INC. · May 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called 83-0060 to see how safe it is, how well it works, and how the body processes it in healthy volunteers. The trial is currently looking for participants who are adults aged 18 to 65 and meet certain health criteria. To be eligible, volunteers should have a healthy body weight and no significant health issues that could affect the study. For example, those with a history of serious illnesses or recent surgeries may not qualify.

Participants in this trial can expect to take either a single dose or multiple doses of the study drug, and their health will be closely monitored throughout the process. This study is important because it helps researchers learn more about how the drug behaves in the body and if it could potentially be used to treat certain conditions in the future. If you or someone you know is interested in being part of this study, it’s essential to understand the requirements and potential risks involved.

Gender

ALL

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.