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

NCT ID: NCT05817708

Last Updated: 2025-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-28
• Study Completion Date: 2023-06-20

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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CX-4945 200mg QD

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

Group Type: EXPERIMENTAL

CX-4945

Intervention Type: DRUG

Drug: CX-4945

Silmitasertib, orally, once or twice daily for 5 days.

Other Name: Silmitasertib

CX-4945 200mg BID

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

Group Type: EXPERIMENTAL

CX-4945

Intervention Type: DRUG

Drug: CX-4945

Silmitasertib, orally, once or twice daily for 5 days.

Other Name: Silmitasertib

CX-4945 400mg BID

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

Group Type: EXPERIMENTAL

CX-4945

Intervention Type: DRUG

Drug: CX-4945

Silmitasertib, orally, once or twice daily for 5 days.

Other Name: Silmitasertib

Interventions

CX-4945

Drug: CX-4945

Silmitasertib, orally, once or twice daily for 5 days.

Other Name: Silmitasertib

Intervention Type: DRUG

Other Intervention Names

Silmitasertib

Eligibility Criteria

Inclusion Criteria

1. Healthy male and female subjects 20to 55 years of age, inclusive, at screening

2. 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

3. 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.

4. Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, and electrocardiogram;

5. Subject with acceptable hematology, biochemistry and urinalysis during screening period.

6. Subject is willing and able to comply with study procedures and sign informed consent.

Exclusion Criteria

1. 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.

2. 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.

3. Subject has received any prescription of drug within 3 days prior to study enrollment.

4. Subject has drug abuse history.

5. Any active or recurring clinically significant hepatic disease including HBV and HCV.

6. Subject has received any investigational agent within 28 days or 5 half-lives, whichever is longer, prior to the first dose of investigational product.

7. Any other medical reason as determined by the investigator.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Senhwa Biosciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jin-Ding Huang, PhD

Role: STUDY_DIRECTOR

Senhwa Biosciences

Locations

Taipei Medical University Hospital

Taipei, , Taiwan

Countries

Taiwan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CX4945-AV04-phase I

Identifier Type: -

Identifier Source: org_study_id