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.
Overview
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Jade Biosciences, Inc.
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Safety and tolerability of single dose of JADE101 in healthy Japanese and Chinese participants
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy male or female participants 18-55 years of age, inclusive
- •First-generation Japanese or Chinese participants born in Japan/China
- •A body weight between 40-100 kg and a body mass index (BMI) between 18.0 - 32.0 kg/m2 (all inclusive) at screening
- •Willing and able to comply with the study site stay, scheduled visits, and study procedures
- •Willing and able to comply with contraceptive and lifestyle requirements from admission through the end of the study
Exclusion Criteria
- •Harmful alcohol use
- •Smoking/vaping or heavy tobacco use within 2 years prior to screening
- •Known history of abuse of illicit drugs
- •Nursing, lactating or pregnant, or who have plans to become pregnant during the study
- •Known history of clinically significant disease
- •Known history of immunodeficiency disorder
- •History of clinically significant allergic reactions or hypersensitivity
Arms & Interventions
JADE101 Groups 1 and 2
Subcutaneous (SC) injection of JADE101
Intervention: JADE101 (Drug)
JADE101 Groups 3 and 4
Subcutaneous (SC) injection of JADE101
Intervention: JADE101 (Drug)
Outcomes
Primary Outcomes
Safety and tolerability of single dose of JADE101 in healthy Japanese and Chinese participants
Time Frame: Day 1 through 48 weeks
Incidence of treatment-emergent adverse events
Cmax
Time Frame: Day 1 through 48 weeks
Maximum observed serum concentration
Tmax
Time Frame: Day 1 through 48 weeks
Time to reach Cmax
AUClast
Time Frame: 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
Time Frame: Day 1 through 48 weeks
Apparent first-order terminal elimination half-life
Secondary Outcomes
- Immunogenicity of JADE101 in healthy Japanese and Chinese participants(Day 1 through 48 weeks)