Clinical trial NCT06214858: The Safety, Tolerability, Pharmacokinetics and Food Effects of SHEN211 Tablet in Healthy Subjects
Official title: To Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effects of SHEN211 Tablet in Healthy Subjects With Fasting Single or Multiple Oral Administration
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Phase 1
Keywords: SHEN211
Safety
tolerability
pharmacokinetics
food effects
Lead sponsor: JKT Biopharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-01-22
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence and severity of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Up to day 63
Secondary outcomes:
measure: Tmax
timeFrame: Up to day 63
measure: Cmax
timeFrame: Up to day 63
measure: AUC
timeFrame: Up to day 63
measure: λz
timeFrame: Up to day 63
measure: t1/2
timeFrame: Up to day 63
Other outcomes:
Locations:
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital, Shandong Province)
state: Shandong
Study officials:
affiliation: University of Paris 5 - Rene Descartes
name: wei zhao, ph.D
role: PRINCIPAL_INVESTIGATOR
References: