Rhematoid ArthritisPhase 1NCT07533955
A Phase 1 Study of JADE201 in Participants With Rheumatoid Arthritis
A Phase 1 study testing JADE201 in people with Rhematoid Arthritis, run by Jade Biosciences, Inc. at 8 sites in 6 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rhematoid Arthritis
- What is being tested?
- JADE201
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 8 sitesin 6 countries
- Study dates
- 19 May 2026to Oct 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female participants 18-70 years of age, inclusive.
- A body weight between 50-100 kg and a body mass index (BMI) between 18-32 kg/m2 (all inclusive) at screening.
- Confirmed diagnosis of RA according to 2010 ACR/EULAR criteria
- 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.
- Willing and able to comply with contraceptive and lifestyle requirements specified in the protocol.
Who cannot join
- With the exception of RA, known history of clinically significant disease
- Diagnosis or symptoms suggestive of any systemic autoimmune or inflammatory condition other than RA
- positive serology for Hep A, Hep B, or Hep C virus
- Positive, indeterminate, or invalid test of TB
- Current tobacco users who smoke >5 cigarettes per day or equivalent
- Nursing, lactating or pregnant, or who have plans to become pregnant during the study
- Treatment with an investigational drug within 30 days or 5 half lives prior to study drug administration
Trial locations and contacts
8 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 6 countries
Romania2 sites, 2 recruiting
- Recruiting
Jade Clinical Site
Bucharest, 011658
Jade201 Study Contact, 781-201-4781, JADE201clinicaltrials@jadebiosciences.com
- Recruiting
Jade Clinical Site
Cluj-Napoca, 400006
Jade201 Study Contact, 781-201-4781, JADE201clinicaltrials@jadebiosciences.com
Ukraine2 sites, 2 recruiting
- Recruiting
Jade Clinical Site
Ivano-Frankivsk, Ukraine, 76018
Jade201 Study Contact, 781-201-4781, JADE201clinicaltrials@jadebiosciences.com
- Recruiting
Jade Clinical Site
Kyiv, Ukraine, 02000
Jade201 Study Contact, 781-201-4781, JADE201clinicaltrials@jadebiosciences.com
Bulgaria1 site, 1 recruiting
- Recruiting
Jade Clinical Site
Sofia, 1618
Jade201 Study Contact, 781-201-4781, JADE201clinicaltrials@jadebiosciences.com
Georgia1 site, 1 recruiting
- Recruiting
Jade Clinical Site
Tbilisi, 0112
Jade201 Study Contact, 781-201-4781, JADE201clinicaltrials@jadebiosciences.com
Germany1 site, 1 recruiting
- Recruiting
Jade Clinical Site
Berlin, 10117
Jade201 Study Contact, 781-201-4781, JADE201clinicaltrials@jadebiosciences.com
Moldova1 site, 1 recruiting
- Recruiting
Jade Clinical Site
Chisinau, Moldova, 2025
Jade201 Study Contact, 781-201-4781, JADE201clinicaltrials@jadebiosciences.com
About this study
Official title: 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
Read the 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
- Being tested
- JADE201, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JADE201Drug
JADE201 is supplied as sterile solution to be administered by SC injection.
PlaceboDrug
Placebo solution to be administered at a matching volume by SC injection.
| Study group | Role | What they receive |
|---|---|---|
| JADE201 | Experimental | Subcutaneous (SC) injection of JADE201 Receives: Drug: JADE201 |
| Placebo | Experimental | Subcutaneous (SC) injection of Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of Single Ascending Doses of JADE201 in participants with Rheumatoid Arthritis
Incidence of treatment-emergent adverse events
Measured: Day 1 through 36 weeks
Secondary outcomes (4)
Cmax
Maximum observed serum concentration
Measured: Day 1 through Weeek 36
Tmax
Time to reach Cmax
Measured: Day 1 through Week 36
AUClast
The area under the concentration-time curve from time zero to the time of the last observed quantifiable (non-zero) concentration
Measured: Day 1 through Week 36
T1/2
Apparent first-order terminal elimination half-life
Measured: Day 1 through Week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start19 May 2026
- Primary completionOct 2027 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhematoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jade Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07533955
- Sponsor's protocol ID
- JADE201-01
- Status last verified
- Oct 2026
- First submitted
- 10 Apr 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No