The Safety, Tolerability, Pharmacokinetics and Food Effects of SHEN211 Tablet in Healthy Subjects

Phase 1 Clinical Trial

Official title:

To Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effects of SHEN211 Tablet in Healthy Subjects With Fasting Single or Multiple Oral Administration

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06214858
• Other study ID #: DEU-1001
• Status: Recruiting
• Phase: Phase 1
• Start date: December 14, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: December 2023
• Source: JKT Biopharma Co., Ltd.
• Contact: steve Shen, ph.D
• Phone: 18016406196
• Email: steve.shen[@]convalife.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a study to evaluate the safety, tolerability, pharmacokinetics, and food effects of SHEN211 tablet in healthy subjects after fasting single or multiple oral administration

Description:

The whole trial consisted of three parts: Part 1 was a single-center, randomized, double-blind, placebo-controlled, single-dose dose increasing safety, tolerability and pharmacokinetic test; Part 2 was a single-center, randomized, double-blind, placebo-controlled, multiple-dose safety, tolerability and pharmacokinetic study. Part 3 is a single-dose, randomized, open, two-phase, double-cross, two-sequence design trial of the effects of food on the main PK parameters of SHEN211 tablets in healthy subjects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: April 30, 2024
• Est. primary completion date: April 2, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Male or female healthy subjects, ages 18-55 (including boundary values)
• The body weight of male subject is not less than 50.0kg, the body weight of female subject is not less than 45.0kg,Body mass index(BMI) in the range of 19.0 ~28.0kg/m2[BMI= weight (kg)/height 2 (m2)] (including the critical value)
• Subjects (including male subjects) are willing to be childfree from screening until 6 months after the last dose of the study drug, voluntarily use effective contraception (see Appendix I), and have no sperm donation plans; Women of childbearing age had to be assessed by a specialist as not pregnant and within 7 days of the start of their last menstrual period before enrollment.
• Sign informed consent before screening, fully understand the test content, process and possible adverse reactions, and be able to complete the study according to the requirements of the test protocol.

Exclusion Criteria:

• Vital signs examination, physical examination, clinical laboratory examination (blood routine, urine routine, blood biochemistry), coagulation function, infection marker examination, pregnancy examination (female only),12-lead electrocardiogram examination, chest X-ray examination, were determined by the investigator to be abnormal and clinically significant
• Any medical history or present medical history that may affect the subject's safety evaluation or study of the drug in vivo process, including but not limited to neurological/psychiatric, respiratory, cardiovascular and cerebrovascular systems, digestive system (any history of gastrointestinal disorders that affect drug absorption), blood and lymphatic system, liver and kidney function, endocrine system, and immune system disorders
• Those who had surgery within 3 months prior to screening or planned to have surgery during the study period, and those who had surgery that would affect drug absorption, distribution, metabolism, or excretion;
• Have a history of allergies to food, drugs, etc., or are known to be allergic to any component of this product
• People who have used any prescription drugs, over-the-counter drugs, Chinese herbs and health products within 2 weeks before screening;
• Any drug that inhibits or induces liver metabolism of drugs (e.g., inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole) used within 28 days prior to screening; Inhibitors -SSRI antidepressants, cimetidine, Diltiazem, macrolides, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines);
• Those who received vaccination within 1 month prior to screening or planned to receive vaccination during the study period;
• Those who consumed an average of more than 14 units of alcohol per week (1 unit of alcohol ˜360mL beer or 45mL spirits with 40% alcohol or 150mL wine) in the three months prior to screening, or could not abstain during the test period, or had a positive alcohol breath at baseline;
• People who smoked an average of more than 5 cigarettes per day in the 3 months prior to the first administration of the study drug, or who could not stop using any tobacco products during the trial period;
• Blood donation or blood loss (=400mL) within 3 months before screening, or blood transfusion;
• Those with a history of drug abuse within 6 months prior to screening;
• Those who had used drugs in the 3 months prior to screening, or who had positive urine screening at baseline;
• Participated in other drug clinical trials within 3 months prior to screening;
• Excessive daily consumption of tea, coffee and/or caffeinated beverages (more than 8 cups on average, 1 cup ˜250mL) in the 3 months before screening;
• Those who have special dietary requirements and cannot accept a unified diet;
• Dysphagia;
• Those with a history of infection (except a history of infection with the novel coronavirus);
• People who are lactose intolerant (those who have had diarrhea from drinking milk);
• Patients who cannot tolerate venipunction or have a history of needle fainting or blood fainting;
• Female subjects who are pregnant or breastfeeding;
• Participants considered inappropriate for clinical trials.

Related Conditions & MeSH terms

• Phase 1

Intervention

Drug:
• SHEN211 tablets
SHEN211 tablets, tablets, specification: 0.11g, 10 tablets/box, storage: sealed, not more than 25? storage.
• SHEN211 placebo tablets
placebo tablets, tablets, specification: 0g, 10 tablets/box, storage: sealed, not more than 25? storage.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital, Shandong Province)	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
JKT Biopharma Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of Treatment-Emergent Adverse Events [Safety and Tolerability]	Safety and Tolerability as assessed by AEs and SAEs	Up to day 63
Secondary	Tmax	Peak time: The time required to reach peak concentration after administration	Up to day 63
Secondary	Cmax	Peak concentration: The highest blood concentration after administration	Up to day 63
Secondary	AUC	Area under the drug time curve: The area surrounded by the blood concentration curve to the time axis.	Up to day 63
Secondary	?z	Terminal elimination rate: The terminal elimination rate constant is obtained from the semilog linear regression of the phase elimination concentration point	Up to day 63
Secondary	t1/2	Terminal elimination half-life: The time required for the terminal phase blood concentration to decrease by half	Up to day 63