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Not yet recruiting Phase 1 NCT07533955

A Phase 1 Study of JADE201 in Participants With Rheumatoid Arthritis

Phase 1 – testing safety in a small group of people
Conditions: Rhematoid Arthritis

Sponsor: Jade Biosciences, Inc.

trial.available_in: БГ
Overview
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
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.
Who can participate
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
Interventions
JADE201
DRUG
Placebo
DRUG
Locations 3
Moldova (1)
Jade Clinical Site
Chisinau , Moldova
Ukraine (2)
Jade Clinical Site
Ivano-Frankivsk , Ukraine
Jade Clinical Site
Kyiv , Ukraine
Technical details
Status
Not yet recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
70 Years
Healthy volunteers
No
Start date
01.05.2026
Completion date
01.10.2028
Registry ID
NCT07533955
Source
clinicaltrials.gov
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