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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Longevity Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Proximod	Multiple-dose to establish the safety and PK profile in both healthy subjects and patients with rheumatoid arthritis
DRUG	Placebo	Placebo controlled

Timeline

• Start date: 2021-12-16
• Primary completion: 2022-02-16
• Completion: 2023-10-08
• First posted: 2024-04-11
• Last updated: 2024-04-19

Locations

1 site across 1 country: China