Rheumatoid ArthritisPhase 1NCT06361186
Proximod Pharmacokinetics In Healthy Subjects
A Phase 1 study testing Proximod in people with Rheumatoid Arthritis, run by Longevity Inc. at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the tolerability, pharmacokinetics and pharmacodynamics of Proximod in healthy subjects. The main questions it arms to answer are: 1. to evaluate the safety and tolerance of Proximod in healthy subjects after single or repeated doses. 2. Read more about this study
- Who is it for?
- Ages 18 to 50 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
- 134 participants
- Where
- 1 siteChina
- Study dates
- 14 Sep 2017to 22 Jun 2021
- 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 50 years
- All sexes
- Healthy volunteers accepted
- 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.
- Normal physical examination and vital signs or abnormal without clinical significance.
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.
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- 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.
- Concomitant inhibitors or inducers of CYP3A4, P-gp or Bcrp such as itraconazole, ketoconazole or dronedarone.
- 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 and clinically significant ophthalmic examination, including fundus examination, optical coherence tomography.
- 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 check-in.
- Those with a positive urine drug screen or a history of drug abuse within the past five years or 3 years before the test.
- Intolerance to standard meals (two boiled eggs, a piece of toast with buttered bacon, a box of fried potato chips, a glass of whole milk).
- Subjects (this article only applies to subjects participating in postprandial trials).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Randomized, Double-blind, Placebo-controlled Phase I Study to Evaluate the Tolerability, Pharmacokinetics and Pharmacodynamics of Proximod in Healthy Subjects.
The goal of this clinical trial is to evaluate the tolerability, pharmacokinetics and pharmacodynamics of Proximod in healthy subjects. The main questions it arms to answer are:
- to evaluate the safety and tolerance of Proximod in healthy subjects after single or repeated doses.
- to learn the pharmacodynamics of Proximod in healthy subjects after single or repeated doses.
- to evaluation of the effect of food on the pharmacokinetics of Proximod in healthy subjects 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
Single and multiple-dose to establish the safety and PK profile
PlaceboDrug
Placebo controlled
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo tablet, qd, oral administration for 28 days Receives: Drug: Placebo |
| test drug | Experimental | Proximod Tablets, 6mg and 12mg, 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 64 days
Time to peak plasma concentration (Tmax)
Measured: Up to 64 days
The lowest plasma concentration (Cmin)
Measured: Up to 64 days
Half-life (t1/2)
Measured: Up to 64 days
Number of adverse events and number of participants with adverse events
Measured: Up to 64 days
Secondary outcomes (2)
Lymphocyte count
Measured: Up to 64 days
Percentage of CD3+CD4+ and CD3+CD8+ T cells
Measured: Up to 64 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start14 Sep 2017
- Primary completion1 Nov 2017
- Study completion22 Jun 2021
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
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Longevity Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06361186
- Sponsor's protocol ID
- BJXH-2017-001
- Status last verified
- Apr 2024
- First submitted
- 12 Mar 2024
- Last updated
- 11 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
Study at a glance
From the registry record, last updated by the sponsor on 11 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 I Study to Evaluate the Tolerability, Pharmacokinetics and Pharmacodynamics of Proximod in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT06361186
- Acronym / sponsor ID
- BJXH-2017-001
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Longevity Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Sep 2017 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 22 Jun 2021 (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.
The goal of this clinical trial is to evaluate the tolerability, pharmacokinetics and pharmacodynamics of Proximod in healthy subjects. The main questions it arms to answer are:
- to evaluate the safety and tolerance of Proximod in healthy subjects after single or repeated doses.
- to learn the pharmacodynamics of Proximod in healthy subjects after single or repeated doses.
- to evaluation of the effect of food on the pharmacokinetics of Proximod in healthy subjects 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 tablet, qd, oral administration for 28 days |
| test drug | Experimental | Drug: ProximodProximod Tablets, 6mg and 12mg, qd, oral administration for 28 days |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 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 (23 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-H001Single and multiple-dose to establish the safety and PK profile | Drug | test drug |
| PlaceboPlacebo controlled | Drug | Placebo |
Primary outcome
Peak plasma concentration (Cmax)
Time frame: Up to 64 days
Time to peak plasma concentration (Tmax)
Time frame: Up to 64 days
The lowest plasma concentration (Cmin)
Time frame: Up to 64 days
Half-life (t1/2)
Time frame: Up to 64 days
Number of adverse events and number of participants with adverse events
Time frame: Up to 64 days
2 secondary outcomes
Lymphocyte count
Time frame: Up to 64 days
Percentage of CD3+CD4+ and CD3+CD8+ T cells
Time frame: Up to 64 days
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 11 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
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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 7 inclusion and 23 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 11 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 64 days). The study lists 5 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 NCT06361186, 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 11 Apr 2024.