Proximod Pharmacokinetics in Healthy Subjects and Patients With Rheumatoid Arthritis

NCT06361199 | Completed Phase 1

• 1 other identifier: BJXH-2021-001
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (6)

• Peak plasma concentration (Cmax)

  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

• Number of adverse events and number of participants with adverse events

  Up to 48 days

Secondary Outcomes (4)

• Lymphocyte count

  Up to 48 days

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo, qd, oral administration for 28 days

Drug: Placebo

Proximod

EXPERIMENTAL

Proximod Tablets, 5mg, qd, oral administration for 28 days

Drug: Proximod

Interventions

Proximod DRUG

Multiple-dose to establish the safety and PK profile in both healthy subjects and patients with rheumatoid arthritis

Also known as: IMM-H001

Proximod

Placebo DRUG

Placebo controlled

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Longevity Inc.: lead

Study Sites (1)

The first hospital of Jilin University

Changchun, Jilin, China

Location

Related Publications (1)

• 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.

  PMID: 39454617 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: April 11, 2024
• Study Start: December 16, 2021
• Primary Completion: February 16, 2022
• Study Completion: October 8, 2023
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)