Rheumatoid Arthritis
Conditions
Brief summary
The goal of this clinical trial is to evaluate the tolerability, pharmacokinetics and pharmacodynamics of Proximod in healthy subjects and patients with rheumatoid arthritis. The main questions it arms to answer are: 1. to evaluate the safety and tolerance of Proximod in health subjects after repeated doses. 2. to assess the pharmacokinetics and pharmacodynamics of Proximod in healthy subjects after repeated doses. 3. to evaluate the safety and tolerance of Proximod in patients with rheumatoid arthritis. 4. to evaluate the pharmacokinetics and pharmacodynamics of Proximod in patients with rheumatoid arthritis. Participants will receive test tablets or placebo at the indicated date and collect blood samples.
Interventions
DRUGProximod
Multiple-dose to establish the safety and PK profile in both healthy subjects and patients with rheumatoid arthritis
DRUGPlacebo
Placebo controlled
Sponsors
Longevity Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
for healthy subjects: * Before the test, sign an informed consent form and fully understand the written test content, process and possible adverse reactions. * Complete research in accordance with the requirements of the trial plan. * Subjects (including partners) are willing to have no pregnancy plans in the next 6 months and voluntarily take effective contraceptive measures. * Male and female subjects aged 18 to 50 years old (including 18 and 50 years old). * Male subjects must weigh no less than 50 kg, and female subjects must weigh no less than 45 kg. Body mass index (BMI) = weight (kg)/height 2 (m2), body mass index is in the range of 18\ 28kg/m2 (including the critical value). * Health status: No clinically significant history of heart, liver, kidney, digestive tract, nervous system, respiratory system (such as asthma, exercise-induced asthma, chronic obstructive pulmonary disease), mental disorder, metabolic abnormality, etc. * Normal physical examination and vital signs or abnormal without clinical significance.
Exclusion criteria
for healthy subjects: * Those who smoked more than 5 cigarettes per day in the 3 months before the test. * Have a history of allergy to the trial drug or its excipients, or allergic constitution (allergy to multiple drugs and food). * Have a history of drug and/or alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine). * Blood donation or significant blood loss (\>450 mL) within three months before screening. * Taking any drugs that alter liver enzyme activity 28 days before screening. * Take any prescription drugs, over-the-counter drugs, any vitamin products or herbal medicines within 14 days before screening. * Those who have taken special diets (including dragon fruit, mango, grapefruit, etc.) or engaged in strenuous exercise within 2 weeks before screening, or other factors that affect drug absorption, distribution, metabolism, excretion, etc. * Recent significant changes in eating or exercise habits. * Participated in a drug clinical trial within three months before taking the study drug. * Have a history of dysphagia or any gastrointestinal disease that affects drug absorption. * Suffering from any disease that increases the risk of bleeding, such as acute gastritis or gastric and duodenal ulcers. * ECG abnormalities have clinical significance or QTC\>470ms in men or QTC\>480ms in women. * Abnormal ophthalmic examination with clinical significance, including fundus examination and optical coherence tomography. * Those who have a history of uveitis and are not suitable to participate in the trial as considered by the researcher. * Those who have a history of herpes zoster or chickenpox. * Female subjects are lactating or have positive serum pregnancy results during the screening period or during the trial. * Clinically significant abnormalities in clinical laboratory tests or other clinically significant following diseases diagnosed within 12 months (including but not limited to gastrointestinal, renal, liver, neurological, blood, endocrine, tumor, lung, immune, psychiatric or Cardiovascular disease). * Positive screening results for viral hepatitis (including hepatitis B and hepatitis C), HIV antibodies, and Treponema pallidum antibodies. * Acute illness or concomitant medication occurs from the screening stage to study medication. * Ingested chocolate, any caffeinated or xanthine-rich food or drink 24 hours before taking study drug. * Positive alcohol breath test 24 hours before taking study medication or upon - Those with a positive urine drug screen or those with a history of drug abuse in the past five years or those who have used drugs 3 months before the test. * Subjects who the researcher believes have other factors that are not suitable for participating in this trial. Inclusion Criteria for patients with rheumatoid arthritis: * Sign an informed consent form before the trial and fully understand the trial content, process and possible adverse reactions. * Age ranges from 18 to 70 years old (both ends included), regardless of gender; * Male subjects must weigh no less than 50 kg, and female subjects must weigh no less than 45 kg. Body mass index (BMI) = weight (kg)/height 2 (m2), body mass index is in the range of 18\ 30 kg/m2 (including the critical value). * Subjects (including partners) are willing to voluntarily take effective contraceptive measures within 6 months from screening to the last dose of study drug. * Diagnosed with rheumatoid arthritis, using the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria . * C-reactive protein or high-sensitivity C-reactive protein (CRP/hsCRP) ≥ the upper limit of normal value during screening. * Have not used any disease-modifying antirheumatic drugs (DMARDs) before the first dose of the trial, or have used methotrexate (MTX) at a stable dose for ≥4 weeks before the first dose, or have used methotrexate, Those who have stopped taking sulfasalazine, chloroquine/hydroxychloroquine, gold preparations, penicillamine and other drugs for ≥7 drug half-lives before the first dose. * The subjects can communicate well with the researchers, understand and comply with the requirements of this study, and can complete the experiment in accordance with the requirements of the trial protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of adverse events and number of participants with adverse events | Up to 48 days |
| Time to peak plasma concentration (Tmax) | Up to 48 days |
| The lowest plasma concentration (Cmin) | Up to 48 days |
| Half-life (t1/2) | Up to 48 days |
| Area under the plasma concentration versus time curve (AUC) | Up to 48 days |
| Peak plasma concentration (Cmax) | Up to 48 days |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of CD3+CD4+ and CD3+CD8+T cells | Up to 48 days |
| ACR20 score in Patients With Rheumatoid Arthritis | Day 8, 15, 22, 29 and 48 compared to baseline |
| Disease Activity Score（DAS28-CRP）in Patients With Rheumatoid Arthritis | Day 8, 15, 22, 29 and 48 compared to baseline |
| Lymphocyte count | Up to 48 days |
Countries
China
Outcome results
None listed