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

Sponsor
Senhwa Biosciences, Inc.
Study ID
NCT05817708
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 28, 2022
Status verified
Dec 2024
Primary completion
Mar 23, 2023
Completion
Jun 20, 2023

Study Design

Enrollment
30 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CX-4945 200mg QD
    CX-4945 will be administered at 200mg QD for continuously 5 days.
  • Experimental: CX-4945 200mg BID
    CX-4945 will be administered at 200mg BID for continuously 5 days.
  • Experimental: CX-4945 400mg BID
    CX-4945 will be administered at 400mg BID for continuously 5 days.

Primary Outcome Measure

Number of Participants With Treatment-emergent Adverse Events (TEAT) [ Time Frame: Day 1 to Day 5 ]

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