Safety, Tolerability and Pharmacokinetics of RNV-166 in Healthy Male Volunteers

This Phase 1 first-in-human clinical study evaluated the safety, tolerability, and pharmacokinetics of RNV-166 following single ascending dose (SAD) and multiple ascending dose (MAD) administration in healthy participants. Single oral doses of RNV-166 ranging from 200 mg to 1600 mg were assessed, including evaluation under fed (high-fat meal) conditions to characterize food effects on pharmacokinetics. Multiple ascending doses were administered once daily for up to 28 days to assess safety, tolerability, and pharmacokinetic profile following repeated dosing.

Inclusion Criteria: 1. Healthy Male subjects between 18 and 40 years of age (both inclusive). 2. Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests, vital signs and ECG. A subject with a clinically significant abnormality or laboratory parameters significantly outside the reference range for the population being studied may be included only if according to the investigator's opinion, the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. 3. AST, ALT, alkaline phosphatase and bilirubin ≤1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \5/day within three months of the study. 10. History of alcohol consumption exceeding, (on average 21 drinks/week for men) within 6 months of the first dose of study medication. 11. Drinking excessive amounts of tea, coffee, chocolate and/or beverage containing caffeine (\> 4 cups / day). 12. Vital signs with a clinically significant abnormality at screening. 13. ECG with a clinically significant abnormality at screening. 14. Laboratory test values outside the clinically acceptable 'normal range' for healthy volunteers at screening. 15. Positive HIV, Hepatitis B or Hepatitis C, Tuberculosis, COVID-19 at screening. 16. Positive urine drug test or positive breath alcohol test at screening or at admission to the clinical unit. 17. Any medication (including St John's Wort) within 14 days before administration, or within 5 times the elimination half-life of that drug, whichever is the longest. 18. Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to dosing. 19. Unable to refrain from consumption of grapefruit and grapefruit juice, orange fruit \& orange juice within 7 days prior to the first dose of study medication. 20. Unwillingness to abstain from sexual intercourse with pregnant or lactating women or to use a condom and spermicide and another form of contraception (e.g., IUD, birth control pills taken by female partner, diaphragm with spermicide) if engaging in sexual intercourse with a woman who could become pregnant until discharge from the study and during 90 additional days. 21. Subjects unlikely to co-operate in the study, and/or poor compliance anticipated by the investigator. 22. Subject being in the exclusion period of a previous trial. 23. Subject who could not be contacted in case of emergency. 24. Subject refusing to give written informed consent. 25. Subject who has received blood or plasma derivatives in the year preceding the study. 26. Subject who has given blood within the past 3 months or have planned to give blood or sperm within the 90 days following the study. 27. Subject who has forfeited their freedom by administrative or legal award, or who is under guardianship or under limited judicial protection.