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Parkinson's DiseasePhase 1NCT06537050

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

A Phase 1 study testing JX2105 in people with Parkinson's Disease, run by Zhejiang Jingxin Pharmaceutical Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Parkinson's Disease
What is being tested?
JX2105
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
52 participants
Where
1 siteChina
Study dates
1 Jul 2024to Mar 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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;
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Ditan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100015

Other trials in China

About this study

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.

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.

Read the 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.

Being tested
JX2105, Placebo
Keywords
Parkinson's disease
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JX2105Drug

    Oral capsule

  • PlaceboDrug

    Oral capsule

Study groups in NCT06537050
Study groupRoleWhat they receive
JX2105Active comparatorJX2105 10mg；JX2105 30mg；JX2105 90mg；JX2105 180mg
Receives: Drug: JX2105
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. TEAE/SAE

    The number, frequency and incidence of TEAE/SAE; The number, frequency and incidence of drug-related TEAE/SAE;

    Measured: Day1 to Day 10

Secondary outcomes (8)

  1. 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;

    Measured: Day1 to Day 10

  2. AUC0-∞

    Area under the drug concentration-time curve of JX2105 and metabolites from 0 to infinity (AUC0-∞)

    Measured: Day1 to Day 10

  3. Tmax

    Peak time of JX2105 and its metabolites

    Measured: Day1 to Day 10

  4. t1/2z

    End phase elimination half-life

    Measured: Day1 to Day 10

  5. λz

    End-phase elimination rate constant

    Measured: Day1 to Day 10

  6. Vz/F

    Apparent volume of distribution

    Measured: Day1 to Day 10

  7. CLz/F

    Apparent clearance

    Measured: Day1 to Day 10

  8. MRT0-last、 MRT0-∞

    Mean residence time

    Measured: Day1 to Day 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2024
  2. Study start1 Jul 2024
  3. Primary completion30 Jan 2025 (estimated)
  4. Study completionMar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Assignment
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06537050
Sponsor's protocol ID
JX2105-I-01
Status last verified
Jul 2024
First submitted
31 Jul 2024
Last updated
5 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JX2105 in people with Parkinson's Disease, run by Zhejiang Jingxin Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

TEAE/SAE (time frame: Day1 to Day 10). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06537050.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024.

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