Single-dose JADE101 in healthy Japanese and Chinese adults
Official title: 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.
Run by Jade Biosciences, Inc. · NCT07525947 · Data updated 2026-11-12
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 | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Jade Biosciences, Inc. Industry-sponsored |
| Locations | 1 site (Glendale, California) |
| Status | Recruiting |
| Started | May 1, 2026 |
| Main results expected | May 2027 |
| Study ends | May 2027 |
| Registry record updated | June 4, 2026 |
| Trial ID | NCT07525947 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
First-in-human test of ZE66-0205 in healthy adults
A single-dose and limited two-dose test in healthy adults will check if ZE66-0205 is safe and how it behaves in the body compared with placebo.
-
Blood Flow Restriction Nordic Hamstring in Elite Adolescent Athletes
This crossover study tests whether adding blood flow restriction to the Nordic Hamstring Exercise changes muscle oxygenation in elite adolescent athletes aged 14–18.
-
How Adimanebart Moves Through the Body in Healthy Adults
This study tests how much adimanebart enters the blood and how it behaves in healthy adults after IV and SC dosing.
-
Electrical nerve stimulation during sleep to boost memory in healthy young adults
This study tests whether applying mild electrical stimulation to the forehead during sleep can improve procedural and working memory in healthy college students.
-
Single-dose HXN6005 testing in healthy adults
This will try a single dose of HXN6005 or a placebo in healthy adults to see if the drug is safe and how it behaves in the body.
-
Checking the safety of the oral drug VT-5006 in adults with and without Parkinson's disease
This will test whether taking an oral medicine called VT-5006 is safe and tolerable for healthy adults and for adults with Parkinson's disease.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.