Healthy Volunteers
Conditions
Keywords
JADE101
Brief summary
This is a Phase 1, first-in-human study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of JADE101 compared to placebo in healthy participants.
Detailed description
This is a single center, Phase 1, double-blind, placebo-controlled, randomized, first-in-human (FIH), single ascending dose study evaluating the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of JADE101 in healthy participants. The study will enroll approximately 32 healthy volunteers. JADE101 will be administered by a subcutaneous injection. The results of this study will help inform the dosing and frequency of dosing in future studies of JADE101.
Interventions
DRUGJADE101
JADE101 is supplied as sterile solution to be administered by SC injection.
DRUGPlacebo
Placebo solution to be administered at a matching volume by SC injection.
Sponsors
Jade Biosciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male or female participants 18-55 years of age, inclusive 2. A body weight between 50-100 kg and a body mass index (BMI) between 18.0 - 32.0 kg/m2 (all inclusive) at screening 3. Willing and able to comply with the study site stay, scheduled visits, and study procedures 4. Willing and able to comply with using two methods of contraception (one being highly effective) 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability of Single Ascending Doses of JADE101 in Healthy Participants | Day 1 through 48 weeks | Incidence of treatment-emergent adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
New Zealand
Outcome results
None listed