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A Phase 1 Study of JADE101 in Healthy Participants

NCT ID: NCT07059312

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-17

Study Completion Date

2026-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy Volunteers

Keywords

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JADE101

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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JADE101

Subcutaneous (SC) injection of JADE101

Group Type EXPERIMENTAL

JADE101

Intervention Type DRUG

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

Placebo

Subcutaneous (SC) injection of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo solution to be administered at a matching volume by SC injection.

Interventions

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JADE101

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

Intervention Type DRUG

Placebo

Placebo solution to be administered at a matching volume by SC injection.

Intervention Type DRUG

Eligibility Criteria

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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 - 32.0 kg/m2 (all inclusive) at screening
3. Willing and able to comply with the study site stay, scheduled visits, and study procedures
4. Willing and able to comply with using two methods of contraception (one being highly effective) 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jade Biosciences, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Li Li, MD

Role: STUDY_DIRECTOR

Jade Biosciences, Inc.

Locations

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NZCR

Auckland, , New Zealand

Site Status

Countries

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New Zealand

Other Identifiers

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JADE101-01

Identifier Type: -

Identifier Source: org_study_id