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NCT06277492

A First-In-Human Study of Single and Multiple Ascending Doses of Oral SUL-238 in Healthy Subjects

A Randomized, Double-blind, Placebo-controlled Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics of Single and Multiple Ascending Oral Doses of SUL-238 in Healthy Subjects
GEN İlaç ve Sağlık Ürünleri A.Ş.·Phase 1·ClinicalTrials.gov·drugRecruiting
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Study focus
Disease/Condition
Healthy Subjects
Drug/Device/Intervention
Single ascending doses SUL-238
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
GEN İlaç ve Sağlık Ürünleri A.Ş.
Location
Kayseri, Turkey
Timeline & enrollment
Phase
Phase 1
Start date
Feb 19, 2024
End date
Nov 08, 2025
Enrollment
69 participants
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
Occupational health examinationSeeking and accepting physical, nutritional and chemical interventions known to be hazardous and harmfulRoutine child health examinationExamination and observation for other reasons
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06277492
Type
Non-Device Trial
About this record

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.