NCT07087262

A Phase I Study of SNH-119014 in Healthy Volunteers

A Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic of SNH-119014 in Healthy Adult Volunteers

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: ScinnoHub Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

SNH-119014 is an oral small-molecule agonist of pyruvate kinase red blood cell isozyme (PKR) being developed for the treatment of hemolytic anemias. This initial study will characterize the safety, tolerability and the pharmacokinetics/pharmacodynamics (PK/PD) of a single ascending dose and multiple ascending doses of SNH-119014 in the context of Phase 1 studies in healthy volunteers. The effects of food on the absorption of SNH-119014 will also be evaluated in healthy volunteers.

Conditions

• Hemoglobinopathy

Interventions

Type	Name	Description
DRUG	SNH-119014	study drug
DRUG	Placebo	placebo

Timeline

• Start date: 2025-06-27
• Primary completion: 2026-03-28
• Completion: 2026-03-28
• First posted: 2025-07-25
• Last updated: 2025-07-25

Locations

1 site across 1 country: China