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

NCT06537050 | Enrolling By Invitation Phase 1

• 1 other identifier: JX2105-I-01
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Keywords

Parkinson's disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Cmax

  Day1 to Day 10

• AUC0-∞

  Day1 to Day 10

• Tmax

  Day1 to Day 10

• t1/2z

  Day1 to Day 10

• λz

  Day1 to Day 10

Study Arms (2)

JX2105

ACTIVE COMPARATOR

JX2105 10mg；JX2105 30mg；JX2105 90mg；JX2105 180mg

Drug: JX2105

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

JX2105 DRUG

Oral capsule

JX2105

Placebo DRUG

Oral capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;
• Having a history or present condition of mental illness;
• 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.;
• Usage of any drugs within 2 weeks before screening, including prescription drugs, over-the-counter drugs and Chinese herbal medicines;
• With a known history of allergy to investigational drug ingredients or similar drugs, history of allergic diseases or allergic constitution;
• Having clinical significance in laboratory test in the opinion of the Investigator, or creatinine clearance \< 80 mL/min;
• Having clinical significant electrocardiogram (ECG) abnormality and chest X-ray examination indicators, in the opinion of the Investigator;
• 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;
• Having one or more clinically significant tests for hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus antibody and treponema pallidum antibody;
• Female participant with positive pregnancy test results;
• History of drug or drug abuse within 1 year before screening, or positive urine drug screening;
• Alcohol abuse within 1 year before screening, with an average weekly alcohol intake of more than 14 units or positive alcohol breath test;
• With average daily smoking ≥ 5 cigarettes within 3 months before screening;
• With no suitable veins for multiple venipuncture/catheterization as assessed at screening;
• 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;

Sponsors & Collaborators

• Zhejiang Jingxin Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Beijing Ditan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100015, China

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 5, 2024
• Study Start: July 1, 2024
• Primary Completion: January 30, 2025
• Study Completion: March 1, 2025
• Last Updated: August 5, 2024

Record last verified: 2024-07

Locations

CN (1)