A Phase 1 Study of JADE201 in Participants With Rheumatoid Arthritis

Jade Biosciences, Inc.

Status and phase: Enrolling; Phase 1

Conditions: Rhematoid Arthritis

Treatments: Drug: JADE201; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07533955

JADE201-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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36 participants in 2 patient groups

JADE201

Experimental group

Description:

Subcutaneous (SC) injection of JADE201

Treatment:

Drug: JADE201

Placebo

Experimental group

Description:

Subcutaneous (SC) injection of Placebo

Treatment:

Drug: Placebo