Clinical Trials in the USA / NCT07525947
Recruiting
Phase 1
A Single Dose, Phase 1 Study of JADE101 in Healthy Japanese and Chinese Participants
NCT07525947 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Healthy Volunteers (HV)
Investigational drug(s) / intervention(s)
JADE101: JADE101 is supplied as sterile solution to be administered by SC injection
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.
Eligibility
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
Primary outcome measure(s)
- Safety and tolerability of single dose of JADE101 in healthy Japanese and Chinese participants — Day 1 through 48 weeks
Incidence of treatment-emergent adverse events - Cmax — Day 1 through 48 weeks
Maximum observed serum concentration - Tmax — Day 1 through 48 weeks
Time to reach Cmax - AUClast — 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 - T1/2 — Day 1 through 48 weeks
Apparent first-order terminal elimination half-life
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Parexel Early Phase Clinical Unit (EPCU) | Glendale | California | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07525947 on ClinicalTrials.gov ↗ ← All trials in the USA