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NCT Number: NCT07525947

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

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.

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Key information

Conditions

Healthy Volunteers (HV)

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Parexel Early Phase Clinical Unit (EPCU)

Glendale, California, 91206, United States

Location status: Recruiting

Location contact

Han

CONTACT

[email protected]

+1-888-228-7425

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

JADE101

Drug

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

Primary outcomes

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

    Time frame: Day 1 through 48 weeks

    Incidence of treatment-emergent adverse events

  2. Cmax

    Time frame: Day 1 through 48 weeks

    Maximum observed serum concentration

  3. Tmax

    Time frame: Day 1 through 48 weeks

    Time to reach Cmax

  4. AUClast

    Time frame: 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

  5. T1/2

    Time frame: Day 1 through 48 weeks

    Apparent first-order terminal elimination half-life

Secondary outcomes

  1. Immunogenicity of JADE101 in healthy Japanese and Chinese participants

    Time frame: Day 1 through 48 weeks

    Incidence and titers of serum anti-drug antibodies (ADAs)

Study contacts

Contact information is provided by the study sponsor or research team.

Han

CONTACT

[email protected]

+1-888-228-7425

Sponsors and collaborators

Lead sponsor

Jade Biosciences, Inc.

Industry

Registry information

Official study title

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.

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 13, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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