A Phase 1 Study of JADE201 in Participants With Rheumatoid Arthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: JADE201, Placebo.
- Who it may be relevant to
- Registry conditions: Rhematoid Arthritis. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Moldova, Ukraine
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
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
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
- Drug JADE201
JADE201 is supplied as sterile solution to be administered by SC injection. - Drug Placebo
Placebo solution to be administered at a matching volume by SC injection.
Primary outcome measures
- Safety and Tolerability of Single Ascending Doses of JADE201 in participants with Rheumatoid Arthritis [Time frame: Day 1 through 36 weeks]
Secondary outcome measures (4)
- Cmax [Time frame: Day 1 through Weeek 36]
- Tmax [Time frame: Day 1 through Week 36]
- AUClast [Time frame: Day 1 through Week 36]
- T1/2 [Time frame: Day 1 through Week 36]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
Ukraine · 2 centers
- Jade Clinical Site — Ivano-Frankivsk
- Jade Clinical Site — Kyiv
Moldova · 1 center
- Jade Clinical Site — Chisinau
Identifiers
NCT: NCT07533955 · JADE201-01