Trials Sponsors Conditions Drugs Pricing

Conditions

COVID-19

Outcome Measures

Primary Outcomes (3)

Comparison of maximum observed concentration(Cmax) profiles of two different kinds of oral STI-1558 to determine the Relative Bioavailability
To compare Cmax of the test preparation (T) 200 mg/ pill × 1 pill on day 1 (D1) and the reference preparation (R) 200 mg/ pill × 1 pill on day 8 (D8) in healthy adult , human subjects under fasting conditions, to establish relative bioavailability.
Up to 2 weeks
Comparison of Area Under the Curve (AUC) from time 0 to last time point(AUC0-t) profiles of two different kinds of oral STI-1558 to determine the Relative Bioavailability
To compare AUC0-t of the test preparation (T) 200 mg/ pill × 1 pill on day 1 (D1) and the reference preparation (R) 200 mg/ pill × 1 pill on day 8 (D8) in healthy adult , human subjects under fasting conditions, to establish relative bioavailability.
Up to 2 weeks
Comparison of AUC from time 0 extrapolated to infinity(AUC0-inf ) profiles of two different kinds of oral STI-1558 to determine the Relative Bioavailability
To compare AUC0-inf of the test preparation (T) 200 mg/ pill × 1 pill on day 1 (D1) and the reference preparation (R) 200 mg/ pill × 1 pill on day 8 (D8) in healthy adult , human subjects under fasting conditions, to establish relative bioavailability.
Up to 2 weeks

Secondary Outcomes (4)

Comparison of Tmax of two different kinds of oral STI-1558 to determine the Relative Bioavailability
Up to 2 weeks
Comparison of t1/2 of two different kinds of oral STI-1558 to determine the Relative Bioavailability
Up to 2 weeks
Comparison of λz of two different kinds of oral STI-1558 to determine the Relative Bioavailability
Up to 2 weeks
Comparison of %AUCex of two different kinds of oral STI-1558 to determine the Relative Bioavailability
Up to 2 weeks

Study Arms (2)

TR group

EXPERIMENTAL

Subjects in the TR group will take the test preparation (T) 200 mg/ pill × 1 pill on day 1 (D1) and the reference preparation (R) 200 mg/ pill × 1 pill on day 8 (D8).

Drug: STI-1558

RT group

EXPERIMENTAL

Subjects in the RT group will take the reference preparation (R) 200 mg/ pill × 1 pill on day 1 (D1) and the test preparation (T) 200 mg/ pill × 1 pill on day 8 (D8).

Drug: STI-1558

Interventions

STI-1558Drug

STI-1558 test preparation and reference preparation

Also known as: An oral small molecule prodrug that effectively inhibits the SARS-CoV-2 main protease (Mpro).

RT groupTR group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 45 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

The subject fully understands the purpose, nature, method and possible adverse reactions of the test, voluntarily becomes a participant, and signs an informed consent form (ICF) before the start of any procedure;
Healthy adult males or females aged 18-45 years (including the threshold) at the time of signing the ICF;

Sponsors & Collaborators

Zhejiang ACEA Pharmaceutical Co. Ltd.
Industrylead

Study Sites (1)

Zhejiang Xiaoshan Hospital

Hangzhou, China

MeSH Terms

Conditions

COVID-19

Interventions

STI-1558

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

Chen Jian, master
Zhejiang Hospital
STUDY CHAIR

Enrollment

32 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

September 15, 2023

First Posted

September 21, 2023

Study Start

September 28, 2023

Actual (reported)

You may not qualify if:

Patients who have difficulty in venous blood collection or have a history of needle fainting or blood fainting;
Pregnant or lactating;
Allergic constitution or allergic to any ingredient in STI-1558 capsule preparation;
Within 1 month prior to screening or within 5 half-lives of the drug (subject to older age) and those who have been enrolled in other clinical trials (including but not limited to investigational drugs, vaccines, biologics, devices, blood products, etc.);
Have a history of gastrointestinal (such as duodenal ulcer, gastrointestinal bleeding), liver or kidney related, or other medical history that the investigator (or his designee) determines may affect the absorption, distribution, metabolism, and excretion of oral drugs;
Have any clinical history of serious diseases (including but not limited to respiratory system, circulatory system, digestive system, blood system, endocrine system, immune system, skin and mucosal system, psychiatric nervous system, ent department and other related diseases);
Those who underwent major surgery within 3 months prior to screening, or did not fully recover from surgery, or planned to have surgery during the study period;
Within 14 days prior to screening and screening of patients with a history of fever;
QT interval prolongation: QTcF \> 450 msec (male); QTcF \> 470 msec (female);
Those who were vaccinated within 14 days prior to screening and those who were screened until check-in or planned to be vaccinated during the study period;
Within 7 days before screening and screening of patients who have used BCRP substrate drugs;
Those who have used CYP3A4 inhibitor, strong inducer, or CYP1A2 inhibitor within 7 days prior to screening and those who have been screened;
Within 14 days prior to screening or within 5 half-lives of the drug (whichever is older), and to those who have been admitted to use any other prescription, over-the-counter or Chinese herbal medicine (other than contraceptive drugs or topical drugs assessed by the investigator to be applicable);
Had a history of drug abuse within 2 years prior to screening, or tested positive for drug abuse upon admission (D-1);
Patients with a history of blood donation or blood loss (excluding female menstrual blood loss) exceeding 400 mL within 3 months before screening;
+6 more criteria

A Bioequivalence Trial of Fasting Single Oral STI-1558 Capsule in Healthy Chinese Subjects

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (4)

Study Arms (2)

TR group

RT group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (4)

Study Arms (2)

TR group

RT group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations