NCT05817708

A Study of Silmitasertib (CX-4945) in Healthy Subject

A Dose Selection Phase 1 Study Evaluating the Safety and Tolerability of Silmitasertib

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Senhwa Biosciences, Inc. · Industry
• Sex: All
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a Phase I single center, open-label, parallel design in 30 subjects to evaluate safety and tolerability of CX-4945 200mg QD, 200 mg BID and 400mg BID doses (10 subjects in each regimen) for continuously 5 days in healthy subjects for dose selection.

Detailed description

COVID-19 is characterized by SARS-CoV-2 induced up-regulation of host protein kinase CK2 that catalyzes phosphorylation of many proteins, modulating their activities in cellular processes. CX-4945 demonstrated anti-viral efficacy in COVID-19 in vitro studies. In CX4945-AV01-IIT(IND 152726), CX-4945 was a safe treatment at 1000 mg BID regimen supported by the fact of no occurrence of treatment related Grade ≥ 3 AE, death or SUSAR. There were approximately 50 % of patients who experienced gastrointestinal disorders of grade 1-2. In CX4945-AV01-IIT, an out-patient study, there were 50% experienced gastrointestinal disorders. To further evaluate the safety and tolerability of CX-4945, this phase 1 study will use lower doses and subjects will be close-monitored to evaluate the safety.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	CX-4945	Drug: CX-4945 Silmitasertib, orally, once or twice daily for 5 days. Other Name: Silmitasertib

Timeline

• Start date: 2022-11-28
• Primary completion: 2023-03-23
• Completion: 2023-06-20
• First posted: 2023-04-18
• Last updated: 2025-01-27
• Results posted: 2025-01-27

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated drug study