Clinical trial NCT06537050: A Randomized, Double-blind, Placebo-controlled Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of JX2105 in Healthy Chinese Subjects
Official title: A Randomized, Double-blind, Placebo-controlled Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of JX2105 in Healthy Chinese Subjects The Purpose of the Study is to Evaluate the Safety, Tolerability After Administration of Single Dose or Multiple Doses, and the Pharmacokinetics (PK) of Single and Multiple Doses of JX2105 in Healthy Study Participants.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
Lead sponsor: Zhejiang Jingxin Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-08-05
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the safety, tolerability after administration of single dose or multiple doses, and the pharmacokinetics (PK) of single and multiple doses of JX2105 in healthy study participants.

Detailed description: Overall design:

This study is divided into 3 parts: Part 1: single-dose escalation study (SAD); Part 2: multiple-dose escalation study (MAD); Part 3: food-effect study (FE). Part 1 includes 7 cohorts; Part 2 includes 2\~3cohorts; and Part 3 food effect study will conduct on 1 dose strength to evaluate the effect of food intake on pharmacokinetic/pharmacodynamics of JX2105 and its metabolites. The doses of part 2 and 3 will be designed according to the PK parameters from Part 1. Maximum recommended human dose of part 1 is 10 mg and the maximum dose is 180 mg.

Eligibility criteria: Inclusion Criteria:

1. Male and female healthy participant must be 18 to 75 years of age inclusive.
2. Body mass index (BMI) within the range 18.5 to 28 kg/m\^2 (inclusive).
3. Subjects must adhere to contraception restrictions from signing the informed consent to 3 months after the last dose.
4. Willing to participate in the clinical trial and provide signed informed consent.

Exclusion Criteria:

1. Having a history or present condition of diseases or dysfunction that may affect the clinical trial on the consideration of investigator, including but not limited to central nervous system, cardiovascular system, respiratory system, digestive system, urinary system, endocrine system, blood system and other diseases;
2. Having a history or present condition of mental illness;
3. Any surgical condition or condition that could significantly affect the absorption, distribution, metabolism, and excretion of the investigational drug or could jeopardize the subjects participating in the trial; such as a history of gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal resection, etc.), urinary tract obstruction or dysuria, gastroenteritis, gastrointestinal ulcer, gastrointestinal bleeding, etc.;
4. Usage of any drugs within 2 weeks before screening, including prescription drugs, over-the-counter drugs and Chinese herbal medicines;
5. With a known history of allergy to investigational drug ingredients or similar drugs, history of allergic diseases or allergic constitution;
6. Having clinical significance in laboratory test in the opinion of the Investigator, or creatinine clearance \< 80 mL/min;
7. Having clinical significant electrocardiogram (ECG) abnormality and chest X-ray examination indicators, in the opinion of the Investigator;
8. Having clinical significance in vital signs, with sitting resting pulse rate \< 50 beats/min or \> 100 beats/min; systolic blood pressure \< 90 mmHg or \> 140 mmHg; diastolic blood pressure \< 50 mmHg or \> 90 mmHg, in the opinion of the Investigator;
9. Having one or more clinically significant tests for hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus antibody and treponema pallidum antibody;
10. Female participant with positive pregnancy test results;
11. History of drug or drug abuse within 1 year before screening, or positive urine drug screening;
12. Alcohol abuse within 1 year before screening, with an average weekly alcohol intake of more than 14 units or positive alcohol breath test;
13. With average daily smoking ≥ 5 cigarettes within 3 months before screening;
14. With no suitable veins for multiple venipuncture/catheterization as assessed at screening;
15. Having blood donation (including blood component donation) or massive blood loss (≥ 200 mL) within 3 months before screening; or receive blood transfusion or using blood products;
16. Having a history of surgery within 3 months before screening, or has not recovered from surgery, or will have a scheduled surgery during the study.

Primary outcomes:
measure: TEAE/SAE
timeFrame: Day1 to Day 10
Secondary outcomes:
measure: Cmax
timeFrame: Day1 to Day 10
measure: AUC0-∞
timeFrame: Day1 to Day 10
measure: Tmax
timeFrame: Day1 to Day 10
measure: t1/2z
timeFrame: Day1 to Day 10
measure: λz
timeFrame: Day1 to Day 10
measure: Vz/F
timeFrame: Day1 to Day 10
measure: CLz/F
timeFrame: Day1 to Day 10
measure: MRT0-last、 MRT0-∞
timeFrame: Day1 to Day 10
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan Hospital, Capital Medical University
state: Beijing
Study officials:
References: