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

Healthy Volunteers Only Clinical Trial

Official title: 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

Status Recruiting

Clinical Trial Summary

This is a clinical study aiming to assess pharmacokinetics, pharmacodynamics and preliminary efficacy of 83-0060 in Healthy Volunteers

Clinical Trial Description

This is a Phase 1, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, PK, PD of orally administered 83-0060 in Healthy Volunteers. The study will be conducted in 2 parts: a single ascending dose (SAD) part at up to 5 dose levels and a multiple ascending dose (MAD) part at up to 2 dose levels. Evaluation of dose levels will be conducted in a sequential fashion with lower dose levels evaluated first in the sequence. ;

Related Conditions & MeSH terms

• Healthy Volunteers Only

• NCT number: NCT06402136
• Study type: Interventional
• Source: Traws Pharma, Inc.
• Contact: Ekaterina Dokukina, MD, MPHIL
• Phone: +382069728309
• Email: kdokukina@chemdiv.com
• Status: Recruiting
• Phase: Phase 1
• Start date: April 15, 2024
• Completion date: September 2024