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

NCT05817708 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: CX4945-AV04-phase I
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

COVID-19

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-emergent Adverse Events (TEAT)

  Evaluate the number adverse events occurring from Day 1 to Day 5 as characterized by type, frequency, severity \[as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0\], timing, seriousness, and relationship to study therapy after administration of 200mg QD, 200mg BID and 400mg BID for continuously 5 days to healthy subjects.

  Day 1 to Day 5

Secondary Outcomes (7)

• Evaluate Changes in Blood Chemistry.

  Day 1 to Day 6

• Evaluate Changes in Blood Chemistry.

  Day 1 to Day 6

• To Evaluate Changes in Blood Chemistry.

  Day 1 to Day 6

• To Evaluate Changes in Blood Chemistry.

  Day 1 to Day 6

• To Evaluate Changes in Blood Chemistry.

  Day 1 to Day 6

Study Arms (3)

CX-4945 200mg QD

EXPERIMENTAL

CX-4945 will be administered at 200mg QD for continuously 5 days.

Drug: CX-4945

CX-4945 200mg BID

EXPERIMENTAL

CX-4945 will be administered at 200mg BID for continuously 5 days.

Drug: CX-4945

CX-4945 400mg BID

EXPERIMENTAL

CX-4945 will be administered at 400mg BID for continuously 5 days.

Drug: CX-4945

Interventions

CX-4945 DRUG

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

Also known as: Silmitasertib

CX-4945 200mg BID; CX-4945 200mg QD; CX-4945 400mg BID

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and female subjects 20to 55 years of age, inclusive, at screening
• Body mass index (BMI)within the range of 18.0 to 30.0 kg/m2, inclusive, and a minimum weight of 50.0 kg at screening
• Subjects who are of reproductive potential agreed to remain abstinent or use (or have their partner use) an acceptable method of birth control (intrauterine device, hormonal contraception, vasectomy or condom) from screening until at least 2 weeks after the last study drug administration.
• Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, and electrocardiogram;
• Subject with acceptable hematology, biochemistry and urinalysis during screening period.
• Subject is willing and able to comply with study procedures and sign informed consent.

You may not qualify if:

• Pregnant or nursing women. NOTE: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and from screening until at least 2 weeks after the last study drug administration. Should a man father a child, or a woman become pregnant or suspect she is pregnant while participating in this study, he or she should inform the treating physician immediately.
• Active or uncontrolled infections such asCOVID-19, HIV or with serious illnesses or medical conditions which would not permit the subject to receive study treatment.
• Subject has received any prescription of drug within 3 days prior to study enrollment.
• Subject has drug abuse history.
• Any active or recurring clinically significant hepatic disease including HBV and HCV.
• Subject has received any investigational agent within 28 days or 5 half-lives, whichever is longer, prior to the first dose of investigational product.
• Any other medical reason as determined by the investigator.

Sponsors & Collaborators

• Senhwa Biosciences, Inc.: lead

Study Sites (1)

Taipei Medical University Hospital

Taipei, 110301, Taiwan

Location

MeSH Terms

Conditions

COVID-19

Interventions

silmitasertib

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Gina Huang
• Organization: Senhwa Biosciences, Inc.

ginahuang@senhwabio.com

+886-2-89119856

Study Officials

• Jin-Ding Huang, PhD

  Senhwa Biosciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: April 18, 2023
• Study Start: November 28, 2022
• Primary Completion: March 23, 2023
• Study Completion: June 20, 2023
• Last Updated: January 27, 2025
• Results First Posted: January 27, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)