Single-dose JADE101 in healthy Japanese and Chinese adults
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.
PHASE1 · Jade Biosciences, Inc. · NCT07525947
This will test how a single dose of JADE101 is tolerated and processed by the bodies of healthy Japanese and Chinese adults.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Jade Biosciences, Inc. (industry) |
| Locations | 1 site (Glendale, California) |
| Trial ID | NCT07525947 on ClinicalTrials.gov |
What this trial studies
In this Phase 1, single-dose study, healthy first-generation Japanese and Chinese adults aged 18–55 receive one dose of JADE101 to collect safety, tolerability, pharmacokinetic, and pharmacodynamic data. Participants must meet weight and BMI criteria and comply with a clinic stay, scheduled visits, and contraceptive and lifestyle requirements. The trial is sponsored by Jade Biosciences and conducted at the Parexel Early Phase Clinical Unit in Glendale, California. Data from this cohort will characterize immediate side effects and how the drug is handled by the body to guide next-step development.
Who should consider this trial
Good fit: Healthy first-generation Japanese or Chinese adults aged 18–55, weighing 40–100 kg with BMI 18.0–32.0 kg/m2, who can travel to and stay at the Glendale clinic and follow study requirements are ideal candidates.
Not a fit: People with clinically significant medical conditions, immunodeficiency, significant allergies, recent tobacco or substance use, or those who are pregnant or breastfeeding are unlikely to receive direct medical benefit from participation.
Why it matters
Potential benefit: If JADE101 is safe and shows favorable pharmacokinetics, the results could support further testing that may eventually lead to new therapeutic options.
How similar studies have performed: Single-dose Phase 1 trials are a standard first step and have successfully characterized safety and pharmacokinetics for many drugs, but JADE101 itself appears to be a novel compound.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Glendale, California
- Parexel Early Phase Clinical Unit (EPCU) — Glendale, California, United States (RECRUITING)
Study contacts
- Study coordinator: Han
- Email: study.losangeles@parexel.com
- Phone: +1-888-228-7425
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Healthy Volunteers, JADE101