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.

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07525947

Enrollment

Registered

2026-04-13

Start date

2026-05-01

Completion date

2027-05-01

Last updated

2026-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers (HV)

Keywords

JADE101

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.

Interventions

DRUGJADE101

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Safety and tolerability of single dose of JADE101 in healthy Japanese and Chinese participants	Day 1 through 48 weeks	Incidence of treatment-emergent adverse events
Cmax	Day 1 through 48 weeks	Maximum observed serum concentration
Tmax	Day 1 through 48 weeks	Time to reach Cmax
AUClast	Day 1 through 48 weeks	The area under the concentration-time curve from time zero to the time of the last observed quantifiable (non-zero) concentration
T1/2	Day 1 through 48 weeks	Apparent first-order terminal elimination half-life

Secondary

Measure	Time frame	Description
Immunogenicity of JADE101 in healthy Japanese and Chinese participants	Day 1 through 48 weeks	Incidence and titers of serum anti-drug antibodies (ADAs)

Countries

United States

Contacts

CONTACTHan

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

STUDY_DIRECTORLi Li, MD

Jade Biosciences

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 5, 2026