A Phase 1 Study of JADE101 in Healthy Participants

Jade Biosciences, Inc.

Status and phase: Active, not recruiting; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: JADE101

Study type: Interventional

Funder types: Industry

Identifiers

NCT07059312

JADE101-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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32 participants in 2 patient groups, including a placebo group

JADE101

Experimental group

Description:

Subcutaneous (SC) injection of JADE101

Treatment:

Drug: JADE101

Placebo

Placebo Comparator group

Description:

Subcutaneous (SC) injection of placebo

Treatment:

Drug: Placebo