A First-In-Human Study of Single and Multiple Ascending Doses of Oral SUL-238 in Healthy Subjects - Trial NCT06277492
Access comprehensive clinical trial information for NCT06277492 through Pure Global AI's free database. This Phase 1 trial is sponsored by GEN İlaç ve Sağlık Ürünleri A.Ş. and is currently Recruiting. The study focuses on Healthy Subjects. Target enrollment is 69 participants.
This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.
Study Focus
Sponsor & Location
GEN İlaç ve Sağlık Ürünleri A.Ş.
Timeline & Enrollment
Phase 1
Feb 19, 2024
Nov 08, 2025
Primary Outcome
Incidence of Treatment-Emergent Adverse Events as Measured by NCI-CTCAE criteria,Incidence of Treatment-Emergent Adverse Events as Measured by Clinical Laboratory Measurements According to Established Clinical Normal Ranges,Incidence of Treatment-Emergent Adverse Events as Measured by ECG,Incidence of Treatment-Emergent Adverse Events as Measured by physical examination and vital signs,Incidence of Treatment-Emergent Adverse Events as Measured by central nervous system (CNS) and autonomic nervous system (ANS) examination.
Summary
The goal of this randomized, double-blind, placebo-controlled, single-center study is to
 evaluate the safety, tolerability, pharmacokinetics of single and multiple oral doses of
 SUL-238 in healthy subjects (aged ≥40 years).
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06277492
Non-Device Trial