A Phase 1 Study of JADE201 in Participants With Rheumatoid Arthritis

April 16, 2026 updated by: Jade Biosciences, Inc.

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male and female participants 18-70 years of age, inclusive.
  2. A body weight between 50-100 kg and a body mass index (BMI) between 18-32 kg/m2 (all inclusive) at screening.
  3. Confirmed diagnosis of RA according to 2010 ACR/EULAR criteria
  4. Willing and able to comply with the inpatient stay at the site, scheduled visits, treatment plans, laboratory tests, and other study procedures specified in the protocol.
  5. Willing and able to comply with contraceptive and lifestyle requirements specified in the protocol.

Exclusion Criteria:

  1. With the exception of RA, known history of clinically significant disease
  2. Diagnosis or symptoms suggestive of any systemic autoimmune or inflammatory condition other than RA
  3. positive serology for Hep A, Hep B, or Hep C virus
  4. Positive, indeterminate, or invalid test of TB
  5. Current tobacco users who smoke >5 cigarettes per day or equivalent
  6. Nursing, lactating or pregnant, or who have plans to become pregnant during the study
  7. Treatment with an investigational drug within 30 days or 5 half lives prior to study drug administration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: JADE201
Subcutaneous (SC) injection of JADE201
Drug: JADE201
JADE201 is supplied as sterile solution to be administered by SC injection.
Experimental: Placebo
Subcutaneous (SC) injection of Placebo
Drug: Placebo
Placebo solution to be administered at a matching volume by SC injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability of Single Ascending Doses of JADE201 in participants with Rheumatoid Arthritis
Time Frame: Day 1 through 36 weeks
Incidence of treatment-emergent adverse events
Day 1 through 36 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: Day 1 through Weeek 36
Maximum observed serum concentration
Day 1 through Weeek 36
Tmax
Time Frame: Day 1 through Week 36
Time to reach Cmax
Day 1 through Week 36
AUClast
Time Frame: Day 1 through Week 36
The area under the concentration-time curve from time zero to the time of the last observed quantifiable (non-zero) concentration
Day 1 through Week 36
T1/2
Time Frame: Day 1 through Week 36
Apparent first-order terminal elimination half-life
Day 1 through Week 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jade Biosciences, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

April 10, 2026

First Submitted That Met QC Criteria

April 10, 2026

First Posted (Actual)

April 16, 2026

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • JADE201-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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