Recruiting
Phase 1

JADE101

Sponsor:

Jade Biosciences, Inc.

Code:

NCT07525947

Conditions

Healthy Volunteers (HV)

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

JADE101

Study Details

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)

Study ID

NCT07525947

Start date

May 1, 2026

Status verified date

Jun, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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 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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: JADE101 Groups 1 and 2

Subcutaneous (SC) injection of JADE101

experimental: JADE101 Groups 3 and 4

Subcutaneous (SC) injection of JADE101

Interventions

JADE101

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

Primary outcome measure

  • Safety and tolerability of single dose of JADE101 in healthy Japanese and Chinese participants [ Time Frame: Day 1 through 48 weeks ]
  • Cmax [ Time Frame: Day 1 through 48 weeks ]
  • Tmax [ Time Frame: Day 1 through 48 weeks ]
  • AUClast [ Time Frame: Day 1 through 48 weeks ]
  • T1/2 [ Time Frame: Day 1 through 48 weeks ]

Central Contacts and Locations

Locations

Parexel Early Phase Clinical Unit (EPCU)

Recruiting

Glendale, California, United States, 91206

Contacts

More Information

Sponsor

Jade Biosciences, Inc.

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Keywords

  • JADE101

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jade Biosciences, Inc. on 2026-06-04.