A Single Dose, Phase 1 Study of JADE101 in Healthy Japanese and Chinese Participants

May 8, 2026 updated by: Jade Biosciences, Inc.

A Phase 1, Open-label, Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of JADE101 Administered Subcutaneously in Healthy Japanese and Chinese Participants.

This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of JADE101 in healthy Japanese and Chinese participants.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Healthy male or female participants 18-55 years of age, inclusive
  2. First-generation Japanese or Chinese participants born in Japan/China
  3. A body weight between 40-100 kg and a body mass index (BMI) between 18.0 - 32.0 kg/m2 (all inclusive) at screening
  4. Willing and able to comply with the study site stay, scheduled visits, and study procedures
  5. Willing and able to comply with contraceptive and lifestyle requirements from admission through the end of the study

Exclusion Criteria:

  1. Harmful alcohol use
  2. Smoking/vaping or heavy tobacco use within 2 years prior to screening
  3. Known history of abuse of illicit drugs
  4. Nursing, lactating or pregnant, or who have plans to become pregnant during the study
  5. Known history of clinically significant disease
  6. Known history of immunodeficiency disorder
  7. History of clinically significant allergic reactions or hypersensitivity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: JADE101 Groups 1 and 2
Subcutaneous (SC) injection of JADE101
Drug: JADE101
JADE101 is supplied as sterile solution to be administered by SC injection
Experimental: JADE101 Groups 3 and 4
Subcutaneous (SC) injection of JADE101
Drug: JADE101
JADE101 is supplied as sterile solution to be administered by SC injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: Day 1 through 48 weeks
Maximum observed serum concentration
Day 1 through 48 weeks
Tmax
Time Frame: Day 1 through 48 weeks
Time to reach Cmax
Day 1 through 48 weeks
AUClast
Time Frame: Day 1 through 48 weeks
The area under the concentration-time curve from time zero to the time of the last observed quantifiable (non-zero) concentration
Day 1 through 48 weeks
T1/2
Time Frame: Day 1 through 48 weeks
Apparent first-order terminal elimination half-life
Day 1 through 48 weeks
Safety and tolerability of single dose of JADE101 in healthy Japanese and Chinese participants
Time Frame: Day 1 through 48 weeks
Incidence of treatment-emergent adverse events
Day 1 through 48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunogenicity of JADE101 in healthy Japanese and Chinese participants
Time Frame: Day 1 through 48 weeks
Incidence and titers of serum anti-drug antibodies (ADAs)
Day 1 through 48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jade Biosciences, Inc.

Investigators

  • Study Director: Li Li, MD, Jade BioSciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

April 6, 2026

First Submitted That Met QC Criteria

April 6, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • JADE101-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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