RecruitingNCT07525947Updated Jun 4, 2026

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

A Phase 1 interventional study of JADE101 in Healthy Volunteers (HV), sponsored by Jade Biosciences, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-04.

Sponsored by Jade Biosciences, Inc. · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 40
Allocation: Non-randomized
Ages: 18 Years to 55 Years
Sex: All

Study summary

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.

Conditions studied

Healthy Volunteers (HV)

Keywords

JADE101

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Non-randomized
Intervention model: Sequential assignment
Masking: None (open label)
Enrollment: 40 participants (estimated)

Study arms

Experimental
JADE101 Groups 1 and 2
Subcutaneous (SC) injection of JADE101
Drug: JADE101
Experimental
JADE101 Groups 3 and 4
Subcutaneous (SC) injection of JADE101
Drug: JADE101

Interventions

DrugJADE101
JADE101 is supplied as sterile solution to be administered by SC injection

What researchers measure

Primary outcomes

Safety and tolerability of single dose of JADE101 in healthy Japanese and Chinese participants
Incidence of treatment-emergent adverse events
Time frame: Day 1 through 48 weeks
Cmax
Maximum observed serum concentration
Time frame: Day 1 through 48 weeks
Tmax
Time to reach Cmax
Time frame: Day 1 through 48 weeks
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 48 weeks
T1/2
Apparent first-order terminal elimination half-life
Time frame: Day 1 through 48 weeks

Secondary outcomes

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

Study locations

1 of 1 sites recruiting

Parexel Early Phase Clinical Unit (EPCU)
Glendale, California 91206, United States
- Han · Contact · study.losangeles@parexel.com · +1-888-228-7425
Recruiting

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT07525947
Lead sponsor: Jade Biosciences, Inc.
Responsible party: Sponsor
First posted: Apr 13, 2026
Start date: May 1, 2026
Primary completion: May 2027 (estimated)
Completion: May 2027 (estimated)
Last update: Jun 4, 2026

Study contacts

Han

Contact

study.losangeles@parexel.com

+1-888-228-7425

Li Li, MD

study director · Jade Biosciences

Oversight

FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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