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

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.

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 Overview

• Status: Enrolling by invitation
• Conditions: Parkinson's Disease
• Intervention / Treatment: Drug: Placebo; Drug: JX2105

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 Type: Interventional
• Enrollment (Estimated): 52
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100015
      • Beijing Ditan Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Oral capsule
Active Comparator: JX2105; JX2105 10mg；JX2105 30mg；JX2105 90mg；JX2105 180mg	Drug: JX2105; Oral capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TEAE/SAE	The number, frequency and incidence of TEAE/SAE; The number, frequency and incidence of drug-related TEAE/SAE;	Day1 to Day 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	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;	Day1 to Day 10
AUC0-∞	Area under the drug concentration-time curve of JX2105 and metabolites from 0 to infinity (AUC0-∞)	Day1 to Day 10
Tmax	Peak time of JX2105 and its metabolites	Day1 to Day 10
t1/2z	End phase elimination half-life	Day1 to Day 10
λz	End-phase elimination rate constant	Day1 to Day 10
Vz/F	Apparent volume of distribution	Day1 to Day 10
CLz/F	Apparent clearance	Day1 to Day 10
MRT0-last、 MRT0-∞	Mean residence time	Day1 to Day 10

Collaborators and Investigators

• Sponsor: Zhejiang Jingxin Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): January 30, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: July 31, 2024
• First Submitted That Met QC Criteria: July 31, 2024
• First Posted (Estimated): August 5, 2024

Study Record Updates

• Last Update Posted (Estimated): August 5, 2024
• Last Update Submitted That Met QC Criteria: July 31, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Parkinson's disease
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: JX2105-I-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No