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

NCT07525947 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: JADE101-05
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers (HV)

Keywords

JADE101

Outcome Measures

Primary Outcomes (5)

• Safety and tolerability of single dose of JADE101 in healthy Japanese and Chinese participants

  Incidence of treatment-emergent adverse events

  Day 1 through 48 weeks

• Cmax

  Maximum observed serum concentration

  Day 1 through 48 weeks

• Tmax

  Time to reach Cmax

  Day 1 through 48 weeks

• AUClast

  The area under the concentration-time curve from time zero to the time of the last observed quantifiable (non-zero) concentration

  Day 1 through 48 weeks

• T1/2

  Apparent first-order terminal elimination half-life

  Day 1 through 48 weeks

Secondary Outcomes (1)

• Immunogenicity of JADE101 in healthy Japanese and Chinese participants

  Day 1 through 48 weeks

Study Arms (2)

JADE101 Groups 1 and 2

EXPERIMENTAL

Subcutaneous (SC) injection of JADE101

Drug: JADE101

JADE101 Groups 3 and 4

EXPERIMENTAL

Subcutaneous (SC) injection of JADE101

Drug: JADE101

Interventions

JADE101 DRUG

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

JADE101 Groups 1 and 2; JADE101 Groups 3 and 4

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jade Biosciences, Inc.: lead

Study Sites (1)

Parexel Early Phase Clinical Unit (EPCU)

Glendale, California, 91206, United States

Location

Study Officials

• Li Li, MD

  Jade Biosciences

  STUDY DIRECTOR

Central Study Contacts

Han

CONTACT

+1-888-228-7425; study.losangeles@parexel.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 13, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)