RecruitingPhase 1interventionalRules rewrite

Phase 1: testing JADE201 for Rhematoid Arthritis

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

Official registry: https://clinicaltrials.gov/study/NCT07533955 · Jade Biosciences, Inc. · enrollment listed as 36

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are JADE201, or Placebo. The registry lists allocation as randomized. This is a Phase 1, first in human study to measure the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of JADE201 compared to dummy treatment (placebo) in participants with Rheumatoid Arthritis

They plan to enroll about 36 people at 8 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: JADE201, Placebo

Primary outcome (registry wording): Safety and Tolerability of Single Ascending Doses of JADE201 in participants with Rheumatoid Arthritis

Who it is for (from inclusion criteria)

Ages 18 Years to 70 Years
Male and female participants 18-70 years of age, inclusive
A body weight between 50-100 kg and a body mass index (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 the registry excludes

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

Public study contact (from the registry)

Jade201 Study Contact

781-201-4781

JADE201clinicaltrials@jadebiosciences.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

8 listed

Jade Clinical Site — Sofia, Bulgaria (recruiting)
Jade Clinical Site — Tbilisi, Georgia (recruiting)
Jade Clinical Site — Berlin, Germany (recruiting)
Jade Clinical Site — Chisinau, Moldova, Moldova (recruiting)
Jade Clinical Site — Bucharest, Romania (recruiting)
Jade Clinical Site — Cluj-Napoca, Romania (recruiting)
Jade Clinical Site — Ivano-Frankivsk, Ukraine, Ukraine (recruiting)
Jade Clinical Site — Kyiv, Ukraine, Ukraine (recruiting)

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FAQ about this NCT record

Is NCT07533955 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07533955?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07533955?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary