A Phase 1 Study of JADE101 in Healthy Participants

Last updated: September 2, 2025
Sponsor: Jade Biosciences, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Healthy Volunteers

Treatment

JADE101

Placebo

Clinical Study ID

NCT07059312
JADE101-01
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This is a Phase 1, first-in-human study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of JADE101 compared to placebo in healthy participants.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Healthy male or female participants 18-55 years of age, inclusive

  2. A body weight between 50-100 kg and a body mass index (BMI) between 18.0 - 32.0kg/m2 (all inclusive) at screening

  3. Willing and able to comply with the study site stay, scheduled visits, and studyprocedures

  4. Willing and able to comply with using two methods of contraception (one being highlyeffective) and lifestyle requirements from admission through the end of the study

Exclusion

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 thestudy

  5. Known history of clinically significant disease

  6. Known history of immunodeficiency disorder

  7. History of clinically significant allergic reactions or hypersensitivity

Study Design

Total Participants: 32
Treatment Group(s): 2
Primary Treatment: JADE101
Phase: 1
Study Start date:
August 17, 2025
Estimated Completion Date:
October 31, 2026

Study Description

This is a single center, Phase 1, double-blind, placebo-controlled, randomized, first-in-human (FIH), single ascending dose study evaluating the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of JADE101 in healthy participants. The study will enroll approximately 32 healthy volunteers. JADE101 will be administered by a subcutaneous injection. The results of this study will help inform the dosing and frequency of dosing in future studies of JADE101.

Connect with a study center

  • NZCR

    Auckland,
    New Zealand

    Site Not Available

  • NZCR

    Auckland 2193733,
    New Zealand

    Active - Recruiting

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