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.

Jade Biosciences, Inc.

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

Age range: 18–55 years
Sex: All
Healthy volunteers: Yes

Detailed criteria

Inclusion Criteria: 1. Healthy male or female participants 18-55 years of age, inclusive 2. First-generation Japanese or Chinese participants born in Japan/China 3. A body weight between 40-100 kg and a body mass index (BMI) between 18.0 - 32.0 kg/m2 (all inclusive) at screening 4. Willing and able to comply with the study site stay, scheduled visits, and study procedures 5. Willing and able to comply with contraceptive 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…

Interventions

Drug
JADE101
JADE101 is supplied as sterile solution to be administered by SC injection

Location

Parexel Early Phase Clinical Unit (EPCU)
Glendale, California
study.losangeles@parexel.com +1-888-228-7425

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.

Summary

Eligibility

Interventions

Location

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Details

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