Rhematoid Arthritis
Conditions
Brief 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.
Interventions
DRUGJADE201
JADE201 is supplied as sterile solution to be administered by SC injection.
DRUGPlacebo
Placebo solution to be administered at a matching volume by SC injection.
Sponsors
Jade Biosciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability of Single Ascending Doses of JADE201 in participants with Rheumatoid Arthritis | Day 1 through 36 weeks | Incidence of treatment-emergent adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | Day 1 through Weeek 36 | Maximum observed serum concentration |
| Tmax | Day 1 through Week 36 | Time to reach Cmax |
| AUClast | 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 |
| T1/2 | Day 1 through Week 36 | Apparent first-order terminal elimination half-life |
Countries
Moldova, Ukraine
Contacts
CONTACTJade201 Study Contact
Outcome results
None listed