Health TrialsbyHealthPanel

A Phase 1 Study of JADE201 in Participants With Rheumatoid Arthritis

ConditionRhematoid Arthritis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorJade Biosciences, Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • JADE201

    Drug

    JADE201 is supplied as sterile solution to be administered by SC injection.

  • Placebo

    Drug

    Placebo solution to be administered at a matching volume by SC injection.

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: JADE201Experimental treatment 1 intervention
Group B: PlaceboExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety and Tolerability of Single Ascending Doses of JADE201 in participants with Rheumatoid Arthritis

Incidence of treatment-emergent adverse events

Time frame
Day 1 through 36 weeks

Secondary outcomes

1

Cmax

Maximum observed serum concentration

Time frame
Day 1 through Weeek 36
2

Tmax

Time to reach Cmax

Time frame
Day 1 through Week 36
3

AUClast

The area under the concentration-time curve from time zero to the time of the last observed quantifiable (non-zero) concentration

Time frame
Day 1 through Week 36
4

T1/2

Apparent first-order terminal elimination half-life

Time frame
Day 1 through Week 36

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jade Biosciences, Inc.

Lead sponsor

Source ClinicalTrials.gov
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