A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SHEN26 Capsule in Healthy Participants

Shenzhen Kexing Pharmaceutical Co., Ltd.1 site in 1 country86 target enrollmentAugust 8, 2022

ConditionsHealthy Participants

InterventionsSHEN26 capsule SHEN26 placebo

DrugsSHEN26 capsule SHEN26 placebo

Overview

Phase: Phase 1
Intervention: SHEN26 capsule
Conditions: Healthy Participants
Sponsor: Shenzhen Kexing Pharmaceutical Co., Ltd.
Enrollment: 86
Locations: 1
Primary Endpoint: The Number and Percentage of Participants With Clinically Significant Abnormal Laboratory Values
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a randomized, double-blind, and placebo-controlled phase I clinical trial. It is designed to assess the safety, tolerability, and pharmacokinetic (PK) profile of SHEN26 capsules after single and multiple ascending dosing in healthy Chinese adult participants, and the food effect on the PK profile of SHEN26 capsules.

Detailed Description

This phase of the study includes three parts: single ascending dose (SAD), food effect (FE), and multiple ascending dose (MAD) in healthy participants. * SAD Part: There are dose groups of 50 mg, 200 mg, 400 mg, 800 mg, and 1200 mg for the SAD part of the trial. * FE Part: This part of the study is tentatively assigned to the 400 mg dose group of the SAD part. After the participants complete the SAD part and pass their safety check on Day 4, they enter the second cycle. Participants are required to fast for more than 10 hours on the night of Day 4, and they will be dosed again on Day 5, 30 min after the start of the high-fat meal (the meal had to be completed within 30 min). * MAD Part: Based on the safety, tolerability, and PK data from the SAD part, if available, the appropriate dose will be selected for the MAD study. Three dose groups of 200 mg, 400 mg, and 600 mg are planned for this part of the study.

Registry

clinicaltrials.gov

Start Date

August 8, 2022

End Date

December 11, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Shenzhen Kexing Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy participants aged 18-45 years (including boundary values, based on the time of signing the informed consent);
•Body mass index (BMI) within the range of 19.0-26.0 kg/m\^2 (including boundary values), with body weight of not less than 50.0 kg for males and 45.0 kg for females;
•Participants were evaluated by the investigator on the basis of their medical history, physical examination, vital signs, 12-lead electrocardiogram, laboratory tests (CBC, CMP, urinalysis, urine microalbumin test, urinary NAG test, coagulation test, serum virology, blood alcohol content, drug abuse screening test, and blood pregnancy test, etc.), abdominal ultrasound, ophthalmologic examination, and chest CT for overall good health status (normal or abnormal test results without clinical significance);
•Fully understand the purpose, nature, methods, and possible adverse events of the trial, volunteer as a participant, and sign an informed consent form;
•The participant and their female partner have no birth plan and voluntarily use effective contraception methods and have no plans to donate sperm or eggs from 2 weeks prior to screening until 6 months after the last dose of the study drug, and to ensure the use of one or more non-pharmacological contraceptive methods during sexual intercourse from 2 weeks prior to screening until 1 month after the last dose of the study drug.

Exclusion Criteria

•Persons with pre-screening or ongoing disease with abnormal clinical manifestations to be excluded, including but not limited to diseases of the nervous/psychiatric system, respiratory system, cardiovascular system, digestive system (any history of gastrointestinal disorders affecting drug absorption), hematologic and lymphatic system, urinary system, endocrine system, and immune system；
•Persons with a history of febrile illness within 14 days prior to screening；
•Persons with dysphagia, history of gastrointestinal surgery or other related medical conditions that may interfere with the absorption and/or elimination of oral medications；
•Persons who have undergone major surgical procedures (excluding diagnostic surgery) within 3 months prior to screening that, in the judgment of the investigator, may interfere with this trial, or who are expected to require major surgery during the trial;
•Persons who have used or anticipate using any drug that induces or inhibits hepatic metabolic enzymes from 28 days prior to screening through the end of the trial;
•Persons who have used or expect to use inhibitors of BCRP prior to screening up to 72 h after the last dose;
•Persons who have used or expect to use inhibitors or inducers of P-gp prior to screening up to 72 h after the last dose;
•Persons who have used any prescription, over-the-counter, herbal or nutraceutical drug within 14 days prior to screening;
•Persons who have a history of substance abuse within 5 years prior to screening or who have used drugs in the 3 months prior to screening;
•Persons with a history of drug or other allergies, particularly to the test drug or any component of the test drug;

Arms & Interventions

SHEN26 capsule (SAD and FE part)

SHEN26 capsule 50mg, 200mg, 400mg, 800mg, and 1200mg dose groups

Intervention: SHEN26 capsule

SHEN26 capsule (MAD part)

SHEN26 capsule 200mg, 400mg, and 600mg dose groups

Intervention: SHEN26 capsule

SHEN26 placebo (SAD and FE part)

SHEN26 placebo 50mg, 200mg, 400mg, 800mg, and 1200mg dose groups

Intervention: SHEN26 placebo

SHEN26 placebo (MAD part)

SHEN26 placebo 200mg, 400mg, and 600mg dose groups

Intervention: SHEN26 placebo