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

NCT05817708 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-01-27

Study results available
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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.

Conditions

Interventions

DRUG

CX-4945

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

Sponsors & Collaborators

  • Senhwa Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Jin-Ding Huang, PhD · Senhwa Biosciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-28
Primary Completion
2023-03-23
Completion
2023-06-20
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05817708 on ClinicalTrials.gov