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.
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Longevity Inc.
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Time to peak plasma concentration (Tmax)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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:
- to evaluate the safety and tolerance of Proximod in health subjects after repeated doses.
- to assess the pharmacokinetics and pharmacodynamics of Proximod in healthy subjects after repeated doses.
- to evaluate the safety and tolerance of Proximod in patients with rheumatoid arthritis.
- 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Placebo
Placebo, qd, oral administration for 28 days
Intervention: Placebo
Proximod
Proximod Tablets, 5mg, qd, oral administration for 28 days
Intervention: Proximod
Outcomes
Primary Outcomes
Time to peak plasma concentration (Tmax)
Time Frame: Up to 48 days
Number of adverse events and number of participants with adverse events
Time Frame: Up to 48 days
Peak plasma concentration (Cmax)
Time Frame: Up to 48 days
The lowest plasma concentration (Cmin)
Time Frame: Up to 48 days
Half-life (t1/2)
Time Frame: Up to 48 days
Area under the plasma concentration versus time curve (AUC)
Time Frame: Up to 48 days
Secondary Outcomes
- 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)