A Randomized, Double-blind, Placebo-controlled Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of JX2105 in Healthy Chinese Subjects

Phase 1

• Conditions: Parkinson's Disease
• Interventions: Drug: JX2105; Drug: Placebo

• Registration Number: NCT06537050
• Lead Sponsor: Zhejiang Jingxin Pharmaceutical Co., Ltd.

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.

Study Timeline

• Status Verified: 2024-07
• Study Start: 2024-07-01
• Study First Submitted: 2024-07-31
• Study First Submitted QC: 2024-07-31
• Last Update Submitted: 2024-07-31
• Study First Posted: 2024-08-05
• Last Update Posted: 2024-08-05
• Primary Completion: 2025-01-30
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
JX2105	JX2105	JX2105 10mg；JX2105 30mg；JX2105 90mg；JX2105 180mg
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
TEAE/SAE	Day1 to Day 10	The number, frequency and incidence of TEAE/SAE; The number, frequency and incidence of drug-related TEAE/SAE;

Secondary Outcome Measures

Name	Time	Method
CLz/F	Day1 to Day 10	Apparent clearance
Cmax	Day1 to Day 10	Peak concentrations (Cmax) of JX2105 and metabolites detected after administration; Area under the drug concentration-time curve (AUC0-last) from 0h to the last sample collection time t where the concentration of JX2105 and metabolites can be accurately determined;
AUC0-∞	Day1 to Day 10	Area under the drug concentration-time curve of JX2105 and metabolites from 0 to infinity (AUC0-∞)
Tmax	Day1 to Day 10	Peak time of JX2105 and its metabolites
t1/2z	Day1 to Day 10	End phase elimination half-life
λz	Day1 to Day 10	End-phase elimination rate constant
Vz/F	Day1 to Day 10	Apparent volume of distribution
MRT0-last、 MRT0-∞	Day1 to Day 10	Mean residence time

Trial Locations

Locations (1)

Beijing Ditan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China