NCT07533955

A Phase 1 Study of JADE201 in Participants With Rheumatoid Arthritis

A Phase 1, Randomized, Double-blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JADE201 Administered Subcutaneously in Participants With Rheumatoid Arthritis

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Jade Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, first in human study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of JADE201 compared to placebo in participants with Rheumatoid Arthritis

Detailed description

This is a multisite, Phase 1, double-blind, placebo-controlled, randomized, first-in-human (FIH), single ascending dose study evaluating the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of JADE201 in participants with Rheumatoid Arthritis. Approximately 36 evaluable participants (6 in each cohort) will be enrolled. JADE201 will be administered by a subcutaneous injection. The results of this study will form the foundation for subsequent clinical development of JADE201 in autoimmune indications.

Conditions

• Rhematoid Arthritis

Interventions

Type	Name	Description
DRUG	JADE201	JADE201 is supplied as sterile solution to be administered by SC injection.
DRUG	Placebo	Placebo solution to be administered at a matching volume by SC injection.

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-10-01
• Completion: 2028-10-01
• First posted: 2026-04-16
• Last updated: 2026-04-16

Locations

3 sites across 2 countries: Moldova, Ukraine