A Single Dose, Phase 1 Study of JADE101 in Healthy Japanese and Chinese Participants
Purpose
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.
Condition
- Healthy Volunteers (HV)
Eligibility
- Eligible Ages
- Between 18 Years and 55 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- 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
- 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
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Basic Science
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental JADE101 Groups 1 and 2 |
Subcutaneous (SC) injection of JADE101 |
|
|
Experimental JADE101 Groups 3 and 4 |
Subcutaneous (SC) injection of JADE101 |
|
Recruiting Locations
Parexel Early Phase Clinical Unit (EPCU)
Glendale, California 91206
Glendale, California 91206
More Details
- Status
- Recruiting
- Sponsor
- Jade Biosciences, Inc.