A Phase 1 Study of JADE201 in Participants With Rheumatoi... | NCT07533955

Studies
A Phase 1 Study of JADE201 in Participants With Rheumatoid Arthritis

NCT07533955

Sponsor

Jade Biosciences, Inc.

Status

Recruiting

Last Update Posted

Jun 1, 2026Actual

Enrollment

36Estimated

Phase

Phase 1

Conditions

Rhematoid Arthritis

Interventions

JADE201
Placebo

Countries

Moldova
Ukraine

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 19, 2026Actual

Primary Completion Date

Oct 2027Estimated

Completion Date

Oct 2028Estimated

First Submitted Date

Apr 10, 2026

First Submission Date that Met QC Criteria

Apr 10, 2026

First Posted Date

Apr 16, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 27, 2026

Last Update Posted Date

Jun 1, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
JADE201	Experimental	Subcutaneous (SC) injection of JADE201	Drug: JADE201
Placebo	Experimental	Subcutaneous (SC) injection of Placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
JADE201	Drug	JADE201 is supplied as sterile solution to be administered by SC injection.	JADE201

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Cmax	Maximum observed serum concentration	Day 1 through Weeek 36
Tmax	Time to reach Cmax	Day 1 through Week 36

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jade201 Study Contact	Contact	781-201-4781		JADE201clinicaltrials@jadebiosciences.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jade Clinical Site	Recruiting	Chisinau	Moldova	2025	Moldova

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided