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A Single Dose, Phase 1 Study of JADE101 in Healthy Japanese and Chinese Participants (NCT07525947) | Clinical Trial Compass

Not Yet RecruitingPhase 1

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

United States40 participantsStarted 2026-05

Plain-language 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.

Who can participate

Age range18 Years – 55 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

✕. 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

What they're measuring

1

Safety and tolerability of single dose of JADE101 in healthy Japanese and Chinese participants

Timeframe: Day 1 through 48 weeks

2

Cmax

Timeframe: Day 1 through 48 weeks

3

Tmax

Timeframe: Day 1 through 48 weeks

4

AUClast

Timeframe: Day 1 through 48 weeks

5

T1/2

Timeframe: Day 1 through 48 weeks

Trial details

NCT IDNCT07525947

SponsorJade Biosciences, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-05

Contact for this trial

Han

+1-888-228-7425 study.losangeles@parexel.com

View on ClinicalTrials.gov More Healthy Volunteers (HV) trials