Proximod Pharmacokinetics in Healthy Subjects and Patients With Rheumatoid Arthritis

A Phase 1 study testing Proximod in people with Rheumatoid Arthritis, run by Longevity Inc. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Rheumatoid Arthritis
What is being tested?: Proximod
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 22 participants
Where: 1 siteChina
Study dates: 16 Dec 2021to 8 Oct 2023
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 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Show all 15Show fewer

Normal physical examination and vital signs or abnormal without clinical significance.
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.

Who cannot join

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.

Show all 51Show fewer

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.
Those who are allergic to the main ingredients and excipients of Prosemod tablets, or have allergies (allergic to multiple drugs and food).
Have any diseases that may affect the absorption of the drug in the body, such as dysphagia or gastrointestinal system diseases.
Abnormal eye examinations with clinical significance, including fundus examination and optical coherence tomography.
Any laboratory test indicator during screening or baseline examination meets the following standards:
AST or ALT>1.5 times ULN Total bilirubin>2 times ULN Hemoglobin (male) <10.0g/dL (100.0g/L), or (female) <9.0g/dL (90.0g/L) Total white blood cell count <3.0×109/L Neutrophil count <1.0×109/L Creatinine clearance rate (CLcr) ≤50 mL/min Any clinically significant laboratory abnormal values that the researcher believes may interfere with the evaluation of the results of this study.
QTC during the electrocardiogram during the screening period is > 470 ms for men and > 480 ms for women, or those who are judged by the researcher to be abnormal and clinically significant and who judge that they cannot be enrolled.
Those who screen positive for viral hepatitis (including hepatitis B and hepatitis C), HIV antibodies, and Treponema pallidum antibodies (positive Treponema pallidum patients need to be tested for RPR, and the researcher will decide whether to be included based on the results), or those who are negative for hepatitis B surface antigen and have hepatitis B surface antigen Antibody negative, hepatitis B core antibody positive and HBV DNA quantification >0.
Female subjects who are lactating or have positive serum pregnancy results during the screening period or trial, or who plan to become pregnant or breast-feeding during the study or within 6 months after the last dose.
Those with positive urine drug screening and alcohol breath tests.
Have a history or evidence of any of the following diseases:
Those with any systemic inflammatory disease except RA. People with Felty syndrome. Decompensated heart failure (New York Heart Association classification III and IV), unstable angina, stroke or transient ischemic attack, myocardial infarction, persistent and Clinically significant arrhythmias, coronary artery bypass grafting, or percutaneous coronary intervention.
Have a history of lymphoproliferative disease, or have various signs or symptoms that may be lymphoproliferative disease, including lymphadenopathy or splenomegaly, or have experienced treated or untreated malignant tumors, whether localized or not Evidence of recurrence or metastasis.
The subject has any active malignant tumor or history of malignant tumor within 5 years before the screening visit, except for cutaneous squamous or basal cell carcinoma, cervical carcinoma in situ, or breast ductal carcinoma in situ that has been treated and considered cured .
Suffer from genetic immunodeficiency or have a family history of hereditary immunodeficiency.
Those who have a history of uveitis and are not suitable to participate in the trial as considered by the researcher.
Those who have undergone joint surgery within 6 months before the first dose of the trial.
Those who have severe infection within 3 months before screening or acute infection symptoms within 7 days before screening are judged by the researcher to be unsuitable participants.
Those who have a history of herpes zoster or chickenpox. Those who have a history of drug abuse or have used drugs within the past five years.
Have cardiovascular, respiratory system, liver, kidney, digestive tract, immune, blood, endocrine, metabolic, psychiatric and neurological diseases or history, which may affect the absorption, distribution, metabolism and excretion of the drug or interfere with the results according to the researcher's judgment evaluator.
10. Use of any of the following drugs or treatments: Received intra-articular, intramuscular injection, intravenous injection, trigger point or tender point, intracapsular, or intratendinous glucocorticoid treatment within 8 weeks before the first dose.
Those who have used any non-steroidal anti-inflammatory drugs (NSAIDs) or oral corticosteroids within 1 week before the first dose of the trial.
Received iguratimod or interferon treatment (such as Lusperin, Ganlenon, Rebetron, etc.) within 1 month before the first dose.
Those who have received any live vaccine, attenuated vaccine or inactivated vaccine within 1 month before the first dose (for example, those who have received the new coronavirus vaccine need to wait 4 weeks or more after completing the last dose before they can be enrolled).
Have used other drugs known to have strong immunosuppressive or immunomodulatory effects (such as Pavlin, Tripterygium wilfordii, Mycophenolate mofetil, Cyclospora) within 4 weeks before the first dose. (e.g., tacrolimus, azathioprine, 6-mercaptopurine, etc.).
Those who have used any other prescription drugs, over-the-counter drugs, Chinese herbal medicines, food or food supplements that may have an impact on the test drug, such as CYP3A4 inhibitors or inducers, within 2 weeks before the first dose of the trial. , grapefruit juice, etc.
Those who smoke, drink alcohol, or drink food and beverages containing xanthine or caffeine, exercise strenuously, or have other factors that affect drug absorption, distribution, metabolism, excretion, etc. 2 days before the first dose of the test.
Those who have participated in any clinical trials of drugs or medical devices within 1 month before screening.
Those who donated blood or suffered massive blood loss (>450 mL) within three months before screening, or those who intend to donate blood during the study or within 1 month after the end of the study.
Subjects who the researcher believes have other factors that are not suitable for participating in this trial.

Trial locations and contacts

1 site in 1 country.

China1 site

The first hospital of Jilin University
Changchun, Jilin

Other trials in China

About this study

Official title: A Single-center, Randomized, Double-blind, Placebo-controlled Phase Ib Study to Evaluate the Tolerability, Pharmacokinetics and Pharmacodynamics of Proximod in Healthy Subjects and Patients With Rheumatoid Arthritis.

to evaluate the safety and tolerance of Proximod in health subjects after repeated doses.
to assess the pharmacokinetics and pharmacodynamics of Proximod in healthy subjects after repeated doses.
to evaluate the safety and tolerance of Proximod in patients with rheumatoid arthritis.
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.

Conditions: Rheumatoid Arthritis
Being tested: Proximod, Placebo
Medical subject headings: Arthritis, Rheumatoid

What participants receive

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

ProximodDrug
Also called IMM-H001
Multiple-dose to establish the safety and PK profile in both healthy subjects and patients with rheumatoid arthritis
PlaceboDrug
Placebo controlled

Study groups in NCT06361199
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo, qd, oral administration for 28 days Receives: Drug: Placebo
Proximod	Experimental	Proximod Tablets, 5mg, qd, oral administration for 28 days Receives: Drug: Proximod

What is being measured

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

Peak plasma concentration (Cmax)
Measured: Up to 48 days
Time to peak plasma concentration (Tmax)
Measured: Up to 48 days
The lowest plasma concentration (Cmin)
Measured: Up to 48 days
Half-life (t1/2)
Measured: Up to 48 days
Area under the plasma concentration versus time curve (AUC)
Measured: Up to 48 days
Number of adverse events and number of participants with adverse events
Measured: Up to 48 days

Secondary outcomes (4)

Lymphocyte count
Measured: Up to 48 days
Percentage of CD3+CD4+ and CD3+CD8+T cells
Measured: Up to 48 days
ACR20 score in Patients With Rheumatoid Arthritis
Measured: Day 8, 15, 22, 29 and 48 compared to baseline
Disease Activity Score（DAS28-CRP）in Patients With Rheumatoid Arthritis
Measured: Day 8, 15, 22, 29 and 48 compared to baseline

Timeline

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

16 Dec 20218 Oct 2023

First posted11 Apr 2024
Study start16 Dec 2021
Primary completion16 Feb 2022
Study completion8 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06361199
Sponsor's protocol ID: BJXH-2021-001
Status last verified: Apr 2024
First submitted: 12 Mar 2024
Last updated: 19 Apr 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Zhang H, Li Q, Li C, Wu M, Chen H, Li Y, You F, Zhao Y, Jin J, Chen X, Ding Y. Evaluation of proximod, a selective agonist of sphingosine-1-phosphate receptor-1, in healthy volunteers and patients with rheumatoid arthritis: a phase 1, double-blind, randomised, placebo-controlled, ascending dose trial. Lancet Rheumatol. 2024 Dec;6(12):e837-e847. doi: 10.1016/S2665-9913(24)00199-1. Epub 2024 Oct 22.
PubMed 39454617

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-center, Randomized, Double-blind, Placebo-controlled Phase Ib Study to Evaluate the Tolerability, Pharmacokinetics and Pharmacodynamics of Proximod in Healthy Subjects and Patients With Rheumatoid Arthritis.
ClinicalTrials.gov ID: NCT06361199
Acronym / sponsor ID: BJXH-2021-001
Conditions: Rheumatoid Arthritis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Longevity Inc.Industry (pharma, biotech, devices)
Study start: 16 Dec 2021 (actual)
Primary completion: 16 Feb 2022 (actual)
Study completion: 8 Oct 2023 (actual)
First posted: 11 Apr 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

to evaluate the safety and tolerance of Proximod in health subjects after repeated doses.
to assess the pharmacokinetics and pharmacodynamics of Proximod in healthy subjects after repeated doses.
to evaluate the safety and tolerance of Proximod in patients with rheumatoid arthritis.
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboPlacebo, qd, oral administration for 28 days
Proximod	Experimental	Drug: ProximodProximod Tablets, 5mg, qd, oral administration for 28 days

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

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).

Key exclusion criteria (51 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ProximodAlso: IMM-H001Multiple-dose to establish the safety and PK profile in both healthy subjects and patients with rheumatoid arthritis	Drug	Proximod
PlaceboPlacebo controlled	Drug	Placebo

Primary outcome

Peak plasma concentration (Cmax)
Time frame: Up to 48 days
Time to peak plasma concentration (Tmax)
Time frame: Up to 48 days
The lowest plasma concentration (Cmin)
Time frame: Up to 48 days
Half-life (t1/2)
Time frame: Up to 48 days
Area under the plasma concentration versus time curve (AUC)
Time frame: Up to 48 days
Number of adverse events and number of participants with adverse events
Time frame: Up to 48 days

4 secondary outcomes

Lymphocyte count
Time frame: Up to 48 days
Percentage of CD3+CD4+ and CD3+CD8+T cells
Time frame: Up to 48 days
ACR20 score in Patients With Rheumatoid Arthritis
Time frame: Day 8, 15, 22, 29 and 48 compared to baseline
Disease Activity Score（DAS28-CRP）in Patients With Rheumatoid Arthritis
Time frame: Day 8, 15, 22, 29 and 48 compared to baseline

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
Derived from this study: PubMed 39454617Zhang H, Li Q, Li C, Wu M, Chen H, Li Y, You F, Zhao Y, Jin J, Chen X, Ding Y. Evaluation of proximod, a selective agonist of sphingosine-1-phosphate receptor-1, in healthy volunteers and patients with rheumatoid arthritis: a phase 1, double-blind, randomised, placebo-controlled, ascending dose trial. Lancet Rheumatol. 2024 Dec;6(12):e837-e847. doi: 10.1016/S2665-9913(24)00199-1. Epub 2024 Oct 22.
Individual participant dataSharing planned: No

Related trials for Rheumatoid Arthritis

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Proximod in people with Rheumatoid Arthritis, run by Longevity Inc. 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 15 inclusion and 51 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: finished, as of the sponsor's last update on 19 Apr 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Peak plasma concentration (Cmax) (time frame: Up to 48 days). The study lists 6 primary outcomes in all. 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 NCT06361199, which also lists 1 linked publication.

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 19 Apr 2024.