Pure Global
NCT06361199

Proximod Pharmacokinetics in Healthy Subjects and Patients With Rheumatoid Arthritis

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.
Longevity Inc.·Phase 1·ClinicalTrials.gov·drugCompleted
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Rheumatoid Arthritis
Drug/Device/Intervention
Proximod
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Longevity Inc.
Location
Changchun, China
Timeline & enrollment
Phase
Phase 1
Start date
Dec 16, 2021
End date
Oct 08, 2023
Enrollment
22 participants
Primary outcome

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

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.

ICD-10 classifications
Rheumatoid arthritis, unspecifiedOther rheumatoid arthritisOther specified rheumatoid arthritisRheumatoid arthritis with involvement of other organs and systemsSeronegative rheumatoid arthritis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06361199
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06361199 through Pure Global AI's free database. This Phase 1 trial is sponsored by Longevity Inc. and is currently Completed. The study focuses on Rheumatoid Arthritis. Target enrollment is 22 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.