Overview
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.
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.
Eligibility
Inclusion Criteria:
- Healthy male or female participants 18-55 years of age, inclusive
- A body weight between 50-100 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 using two methods of contraception (one being highly effective) 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