ClinicalTrials.gg
RecruitingNCT07525947Updated Jun 4, 2026

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

A Phase 1 interventional study of JADE101 in Healthy Volunteers (HV), sponsored by Jade Biosciences, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-04.

Sponsored by Jade Biosciences, Inc. · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Started May 2026; still recruiting 6 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Volunteers (HV)

Keywords

  • JADE101
03

In context

Lead sponsor

Jade Biosciences, Inc. is the lead sponsor of 5 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (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 and lifestyle requirements from admission through the end of the study

Exclusion criteria

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 disease
  6. Known history of immunodeficiency disorder
  7. History of clinically significant allergic reactions or
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    JADE101 Groups 1 and 2

    Subcutaneous (SC) injection of JADE101

    Drug: JADE101

  • Experimental
    JADE101 Groups 3 and 4

    Subcutaneous (SC) injection of JADE101

    Drug: JADE101

Interventions

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

06

What researchers measure

Primary outcomes

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

    Incidence of treatment-emergent adverse events

    Time frame: Day 1 through 48 weeks

  2. Cmax

    Maximum observed serum concentration

    Time frame: Day 1 through 48 weeks

  3. Tmax

    Time to reach Cmax

    Time frame: Day 1 through 48 weeks

  4. AUClast

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

    Time frame: Day 1 through 48 weeks

  5. T1/2

    Apparent first-order terminal elimination half-life

    Time frame: Day 1 through 48 weeks

Secondary outcomes

  1. Immunogenicity of JADE101 in healthy Japanese and Chinese participants

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

    Time frame: Day 1 through 48 weeks

07

Study locations

1 of 1 sites recruiting
  • Parexel Early Phase Clinical Unit (EPCU)
    Glendale, California 91206, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07525947
Lead sponsor
Jade Biosciences, Inc.
Responsible party
Sponsor
First posted
Apr 13, 2026
Start date
May 1, 2026
Primary completion
May 2027 (estimated)
Completion
May 2027 (estimated)
Last update
Jun 4, 2026

Study contacts

Han
Contact
study.losangeles@parexel.com
+1-888-228-7425
Li Li, MD
study director · Jade Biosciences

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

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Studies of the drug tested here: JADE101

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