Tier 2 — strong
Phase 1, Single-Center, Double-Blind, Randomized, Placebo-Controlled Studies of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of the Sirtuin 6 Activator SP-624 in Healthy Adults
Clinical Pharmacology in Drug Development
2025
14(1):18-25
Bibliography
- PubMed
- PMID 39587867
- PubMed Central
- PMC11701958
- Funding
- The publication is a Sirtsei Pharmaceuticals study; the article copyright identifies Sirtsei Pharmaceuticals and the authors are affiliated with Sirtsei/Arrivo BioVentures.
- Competing interests
- All authors reported consulting for Sirtsei Pharmaceuticals, a wholly owned subsidiary of Arrivo BioVentures, and all reported minority equity interests in Arrivo BioVentures.
Study snapshot
| Design | Two Phase 1 randomized, double-blind, placebo-controlled single- and multiple-ascending-dose studies with a food-effect component. |
|---|---|
| Model | Healthy adult volunteers. |
| Sample | Multiple small Phase 1 cohorts across SP-624-101 and SP-624-102; cohort allocations are reported in the paper. |
| Intervention | SP-624 single doses of 3, 10 or 30 mg; repeated 3 or 10 mg daily for 5 days and 20 mg daily for 10 days, versus placebo. |
| Duration | Single dose to 10 days depending on cohort. |
| Endpoints | Safety and treatment-emergent adverse events; pharmacokinetics; Cmax; AUC; food effect |
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