NCT07533955

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

Trial Health

67
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
29mo left

Started May 2026

Typical duration for phase_1

Geographic Reach
2 countries

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 16, 2026

Completed
15 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Expected
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

1.4 years

First QC Date

April 10, 2026

Last Update Submit

April 10, 2026

Conditions

Rhematoid Arthritis

Outcome Measures

Primary Outcomes (1)

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

    Incidence of treatment-emergent adverse events

    Day 1 through 36 weeks

Secondary Outcomes (4)

  • Cmax

    Day 1 through Weeek 36

  • Tmax

    Day 1 through Week 36

  • AUClast

    Day 1 through Week 36

  • T1/2

    Day 1 through Week 36

Study Arms (2)

JADE201

EXPERIMENTAL

Subcutaneous (SC) injection of JADE201

Drug: JADE201

Placebo

EXPERIMENTAL

Subcutaneous (SC) injection of Placebo

Drug: Placebo

Interventions

JADE201DRUG

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

JADE201
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Jade Clinical Site

Chisinau, Moldova, 2025, Moldova

Location

Jade Clinical Site

Ivano-Frankivsk, Ukraine, 76018, Ukraine

Location

Jade Clinical Site

Kyiv, Ukraine, 02000, Ukraine

Location

Central Study Contacts

Jade201 Study Contact

CONTACT

781-201-4781JADE201clinicaltrials@jadebiosciences.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2026

First Posted

April 16, 2026

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2028

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

MO(1)UA(2)