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Proximod Pharmacokinetics in Healthy Subjects and Patients With Rheumatoid Arthritis - Trial NCT06361199

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.

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NCT06361199
Phase 1
Completed
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06361199
View on ClinicalTrials.gov
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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.

Study Focus

Rheumatoid Arthritis

Proximod

Interventional

drug

Sponsor & Location

Longevity Inc.

Changchun, China

Timeline & Enrollment

Phase 1

Dec 16, 2021

Oct 08, 2023

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, unspecified
Other rheumatoid arthritis
Other specified rheumatoid arthritis
Rheumatoid arthritis with involvement of other organs and systems
Seronegative rheumatoid arthritis

Data Source

ClinicalTrials.gov

NCT06361199

Non-Device Trial