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COMPLETEDPHASE1

Safety and Efficacy Study of STI-1558 in Healthy Adults and SARS-CoV-2-Positive Patients

A Randomized, Double-Blind, Placebo-Controlled, Phase I Clinical Study Evaluating the Safety of a Single Ascending Dose of STI-1558 in Healthy Subjects and the Safety, Pharmacokinetics, and Efficacy of Multiple Ascending Doses of STI-1558 in SARS-CoV-2-Positive Subjects

NCT05523739•Zhejiang ACEA Pharmaceutical Co. Ltd.

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety of STI-1558 in healthy subjects and the safety, pharmacokinetics, and efficacy in SARS-CoV-2-Positive subjects.

Detailed Description

This is a two-part, randomized, double-blind, placebo-controlled study evaluating the safety and pharmacokinetics (PK) of a single ascending dose of STI-1558 in healthy subjects and the safety, PK and efficacy of a multiple ascending dose in SARS-CoV-2-positive subjects.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Part 1
•1. Subjects are fully informed of the study and sign the informed consent document prior to any procedure.
•2. Healthy subjects aged ≥18 but ≤45 years old, regardless of gender.
•3. BMI ≥18, but ≤30kg/m2, and weight ≥45, but ≤100kg.
•4. Good health status, with normal or abnormal and not clinically significant (NCS) results of medical history, vital signs, physical examination, 12-lead electrocardiogram, laboratory tests (blood routine, blood chemistry, urine routine, coagulation function) and thyroid function (TSH, FT3, FT4) during the screening period.
•5. Must be willing and able to comply with all planned study procedures.
•6. Women of childbearing potential (WOCBP) (infertile women defined as having undergone hysterectomy or bilateral oophorectomy or bilateral salpingectomy or bilateral tubal ligation/closure, or who are infertile due to a congenital or acquired condition or spontaneously menopausal for ≥ 12 months) must have a negative blood pregnancy test during screening. Fertility female and male subjects must use a highly effective method of contraception from the screening period to 90 days after the last dose of study drug.
•Part 2
•1. Subjects are fully informed of the study and sign the informed consent document prior to any procedure.
•2. Age ≥ 18, but \< 65 years old, gregardless of gender.
+16 more criteria

Exclusion Criteria

•1. Subjects who faint with needles, faint with blood, or have difficulty collecting venous blood.
•2. Known hypersensitivity to any of the ingredients of this product.
•3. Participated in an interventional clinical trial within 30 days before D1 or within 5 half-lives (whichever is longer).
•4. Subjects who have a history of gastrointestinal (such as duodenal ulcer, gastrointestinal bleeding), liver or kidney-related medical history, or other medical history that may affect the absorption, distribution, metabolism, and excretion of oral drugs as assessed by the investigator.
•5. Subjects who have undergone major surgery within 3 months prior to screening, or who have not fully recovered from surgery, or who plan to undergo surgery during the study period.
•6. Take foods, juices or beverages containing alcohol, grapefruit, lime, cinchona bark and quinine within 24 hours prior to D1.
•7. Use of BCRP substrate drugs within 7 days prior to D1 (see "6.5.1 Prohibited Drugs and Treatments").
•8. History of substance abuse within 2 years prior to screening.
•9. Subjects who have donated blood (including blood components donation) or lost more than 400 mL of blood within 3 months prior to screening.
•10. History of alcohol abuse (defined as: more than 14 units of alcohol per week, 1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of spirit containing 40% alcohol) within 3 months prior to screening.
+26 more criteria

Locations (1)

The Third People's Hospital Of Shenzhen

Shenzhen, Guangdong, China

Key Dates

Start Date

September 16, 2022

Primary Completion Date

December 21, 2022

Completion Date

March 29, 2023

Last Updated

August 14, 2023

Enrollment

ACTUAL participants

Conditions

SARS-CoV-2 Infection

Interventions

STI-1558

DRUG

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Long COVIDSars-CoV-2 Infection+2 more

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RECRUITINGPHASE1

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SARS-CoV-2 Infection

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 14, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Efficacy Study of STI-1558 in Healthy Adults and SARS-CoV-2-Positive Patients

Inclusion Criteria

Exclusion Criteria

Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID

T Cell Therapy Opposing Novel COVID-19 Infection in Immunocompromised Patients

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Clinical Outcomes and Pharmacotherapy Effectiveness in the VA Health Care System (COPE-VA)

A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age

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