Proximod Pharmacokinetics in Healthy Subjects and Patients With Rheumatoid Arthritis

Phase 1

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Placebo; Drug: Proximod

• Registration Number: NCT06361199
• Lead Sponsor: Longevity Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-16
• Primary Completion: 2022-02-16
• Study Completion: 2023-10-08
• Study First Submitted: 2024-03-12
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-07
• Study First Posted: 2024-04-11
• Last Update Submitted: 2024-04-18
• Last Update Posted: 2024-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo, qd, oral administration for 28 days
Proximod	Proximod	Proximod Tablets, 5mg, qd, oral administration for 28 days

Primary Outcome Measures

Name	Time	Method
The lowest plasma concentration (Cmin)	Up to 48 days
Time to peak plasma concentration (Tmax)	Up to 48 days
Number of adverse events and number of participants with adverse events	Up to 48 days
Peak plasma concentration (Cmax)	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The first hospital of Jilin University; 🇨🇳 Changchun, Jilin, China