RecruitingPhase 1NCT07525947

A Single Dose, Phase 1 Study of JADE101 in Healthy Japanese and Chinese Participants

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.

Sponsor

Jade Biosciences, Inc.

Enrollment

40 participants

Start Date

May 1, 2026

Study Type

INTERVENTIONAL

Conditions

Healthy Volunteers (HV)

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

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria5

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 Criteria7

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