A Phase 1 Study of JADE101 in Healthy Participants

Launched by JADE BIOSCIENCES, INC. · Jul 9, 2025

Keywords

ClinConnect Summary

This clinical trial is an early-stage study to test a new medicine called JADE101 in healthy adults. The main goal is to see if the medicine is safe and well-tolerated when given in increasing doses, and to understand how the body processes and responds to it. This study will compare JADE101 to a placebo, which is a harmless substance that looks like the medicine but has no active ingredients.

Adults between 18 and 55 years old who are generally healthy, weigh between 50 and 100 kg (about 110 to 220 pounds), and have a body mass index (BMI) within a certain range may be eligible to participate. Participants must be willing to stay at the study site for visits and follow certain lifestyle rules, including using two forms of birth control during the study if applicable. People who smoke, use drugs, have certain health conditions, or are pregnant cannot join. If you take part, you can expect careful monitoring by the study team to make sure you stay safe while they learn more about how JADE101 works in the body.

Gender

ALL

Eligibility criteria

• 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