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NCT07525947
A Single Dose, Phase 1 Study of JADE101 in Healthy Japanese and Chinese Participants
Conditions: Healthy Volunteers (HV)
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 40
Sponsor: Jade Biosciences, Inc.
Location: Parexel Early Phase Clinical Unit (EPCU) Glendale California
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 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
Source: ClinicalTrials.gov (NCT07525947). StuddyBuddy aggregates publicly available trial information.