Clinical trial NCT06093308: A Study in Elderly Chinese Subjects With Underlying Diseases
Official title: A Phase 1, Open-label, Single-and Multiple-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of JT001 Administered Orally in Elderly Chinese Subjects With Underlying Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Elderly Subjects With Underlying Diseases
Lead sponsor: Shanghai Vinnerna Biosciences Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Sponsor GmbH
First posted: 2023-10-23
Enrollment: 18
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Evaluate the safety and tolerability of oral JT001 tablets in elderly subjects with underlying diseases.

Evaluate the pharmacokinetic characteristics of JT001 tablets orally administered to elderly subjects with underlying diseases.

Explore the drug drug interactions between JT001 tablets and some drugs in elderly subjects with underlying diseases who have been orally administered multiple times.

Detailed description: The open-label, single-center phase I study to evaluate the safety, tolerability, and pharmacokinetics of JT001 single-and multiple-dose administered orally in elderly subjects with underlying diseases.Approximately 16 to 18 elderly subjects will be enrolled aging beyound 60 years.

All subjects received JT001, oral administration after meals, D1: 0.6g, twice a day; D2-D5: 0.3g, twice a day; D6: 0.3g, administered once in the morning.Blood samples will be collected at times sufficient to adequately define the pharmacokinetics of JT001 active metabolite(116N-1) in elderly groups.The steady-state trough concentration of therapeutic drug monitoring (TDM) for the basic medication of the subjects will be collected as well.

Subjects will be admitted to the phase I clinical trial ward 2 days before administration (D-2) and will not be allowed to leave until all examinations and assessments are completed on day 8. Telephone follow-up will be performed on day 12 (±1 day).

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 60 years old, regardless of gender;
2. Weight: Male ≥ 50 kg, female ≥ 45 kg; Body mass index (BMI) within the range of 18-30 kg/m2 (including 18 and 30);
3. Subjects suffer from chronic basic diseases and have stable disease control (such as well controlled hypertension, hyperlipidemia, diabetes, etc.);
4. At least 2 weeks before enrollment, the treatment plan for chronic underlying diseases of the subjects has not been adjusted, and the usage, dosage, and duration of the treatment drugs remain unchanged;
5. During the study period, the subjects were willing to discontinue non essential concomitant medications or health products (excluding essential treatment drugs for chronic underlying diseases of the subjects, and the specific drugs and health products were determined by the researchers and specialist doctors in consultation);
6. The results of vital signs, physical examinations, routine laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function, etc.), 12-lead electrocardiogram, chest X-ray, abdominal ultrasound, etc. are normal or abnormal, but the researchers determine that they are related to age and chronic diseases. After enrollment, the safety risk of the subjects is low and does not affect the study observation indicators;
7. Those who understand the research procedures and methods, voluntarily participate in this study, and sign an informed consent form in writing.

Exclusion Criteria:

1. Individuals with a known history of allergies, allergic diseases, or allergic constitutions to the research formulation, any of its components, or related preparations;
2. Any surgical situation or condition that may significantly affect the absorption, distribution, metabolism, and excretion of drugs, or any surgical situation or condition that may pose a hazard to the participants in the study, such as a history of gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal resection, etc.), a history of gastroenteritis, gastrointestinal ulcers, gastrointestinal bleeding, history of malignant tumors, etc. (excluding cholecystectomy);
3. Those who have experienced the following conditions within 3 months prior to the administration of the study drug: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass grafting, congestive heart failure, severe arrhythmia, cerebrovascular accidents, including transient ischemic attacks;
4. Individuals who have experienced blood loss of ≥ 400 mL within the first 3 months of enrollment;
5. Individuals who have participated in clinical research on other drugs or medical devices within the first 3 months of being selected;
6. Drink alcohol at least twice a day or more than 14 times a week within 6 months before selection, or indulge in excessive drinking (one drink is defined as 125 mL of wine, 220 mL of beer or 50 mL of Baijiu; excessive drinking is defined as five or more drinks within about 2 hours);
7. Individuals with a history of drug use or positive drug abuse screening;
8. Those who smoke more than 10 cigarettes per day within the first 6 months of enrollment;
9. Positive individuals for hepatitis B surface antigen (HBsAg), HCV antibody, Treponema pallidum antibody, and HIV antibody;
10. Researchers believe that there are other factors that are not suitable for participating in the study.

Primary outcomes:
measure: The severity of SAE
timeFrame: From Day 1(first dose) to Day12
measure: The Number of participants with SAE
timeFrame: From Day 1(first dose) to Day12
measure: The severity ofclinical symptoms abnormalities(e.g.,Dizziness, headache, nausea, abdominal pain, fatigue, drowsiness）
timeFrame: From Day 1(first dose) to Day12
measure: The Number of participantswith abnormal clinical symptoms(e.g.,Dizziness, headache, nausea, abdominal pain, fatigue, drowsiness）
timeFrame: From Day 1(first dose) to Day12
measure: The severity of vital signs abnormalities
timeFrame: From Day 1(first dose) to Day12
measure: The Number of participantswith abnormal vital signs
timeFrame: From Day 1(first dose) to Day12
measure: The severity of vital signs abnormalities
timeFrame: From Day 1(first dose) to Day12
measure: The Number of participantswith abnormal vital signs
timeFrame: From Day 1(first dose) to Day12
measure: The severity of vital signs abnormalities
timeFrame: From Day 1(first dose) to Day12
measure: The Number of participantswith abnormal vital signs
timeFrame: From Day 1(first dose) to Day12
measure: The severity of vital signs abnormalities
timeFrame: From Day 1(first dose) to Day12
measure: The Number of participantswith abnormal vital signs
timeFrame: From Day 1(first dose) to Day12
measure: The severity of vital signs abnormalities
timeFrame: From Day 1(first dose) to Day12
measure: The Number of participantswith abnormal physical examinations findings
timeFrame: From Day 1(first dose) to Day12
measure: The severity of abnormal laboratory tests results
timeFrame: From Day 1(first dose) to Day12
measure: The Number of participantswith abnormal laboratory tests results
timeFrame: From Day 1(first dose) to Day12
measure: The severity of electrocardiogram (ECG) abnormalities
timeFrame: From Day 1(first dose) to Day7
measure: The Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: From Day 1(first dose) to Day7
measure: The severity of electrocardiogram (ECG) abnormalities
timeFrame: From Day 1(first dose) to Day7
measure: The Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: From Day 1(first dose) to Day7
measure: The severity of electrocardiogram (ECG) abnormalities
timeFrame: From Day 1(first dose) to Day7
measure: The Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: From Day 1(first dose) to Day7
measure: The severity of electrocardiogram (ECG) abnormalities
timeFrame: From Day 1(first dose) to Day7
measure: The Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: From Day 1(first dose) to Day7
measure: The severity of electrocardiogram (ECG) abnormalities
timeFrame: From Day 1(first dose) to Day7
measure: The Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: From Day 1(first dose) to Day7
Secondary outcomes:
measure: The Cmax of the main metabolite 116-N1 of JT001;
timeFrame: Day 1/Day 5 and Day 6 after first dose
measure: The AUC0-t of the main metabolite 116-N1 of JT001;
timeFrame: Day 1/Day 5 and Day 6 after first dose
measure: The AUC0-inf of the main metabolite 116-N1 of JT001;
timeFrame: Day 1/Day 5 and Day 6 after first dose
Other outcomes:
measure: The steady-state trough concentration of therapeutic drug monitoring (TDM) for the basic medication of the subjects.
timeFrame: Day 2 and Day 1before first dose and Day 6/Day 7/Day 8 after first dose
Locations:
city: Shanghai
country: China
facility: Shanghai Xuhui Central Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Vinnerna Biosciences Co., Ltd.
name: Huiyu Lan, Project Director
role: STUDY_DIRECTOR
References: