Pharmacokinetics, Safety, and Tolerability of Anti-miR-17 Oligonucleotide RGLS4326 in Healthy Adult Subjects - PubMed
3 days ago
- #clinical trial
- #pharmacokinetics
- #miR-17 inhibitor
- RGLS4326 is an anti-miR-17 oligonucleotide evaluated in Phase 1 studies for pharmacokinetics, safety, and tolerability in healthy adults.
- Single-ascending doses ranged from 0.05 to 6 mg/kg, and multiple-ascending doses were 0.1, 0.3, and 1 mg/kg every two weeks.
- Plasma exposures increased dose-proportionally, with elimination half-lives varying by injection site (abdomen: ~3-8h, arm/thigh: ~11-20h).
- Urinary excretion of RGLS4326 ranged from 37% to 63% in SAD and 35.2% to 48.1% in MAD studies, indicating significant renal clearance.
- RGLS4326 was generally well-tolerated with no dose-limiting treatment-emergent adverse events observed.