A Phase 1 Study of JADE101 in Healthy Participants

Not Applicable

Recruiting

• Conditions: Healthy Volunteers
• Interventions: Drug: JADE101; Drug: Placebo

• Registration Number: NCT07059312
• Lead Sponsor: Jade Biosciences, Inc.

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2025-06-27
• Study First Submitted QC: 2025-07-09
• Study First Posted: 2025-07-10
• Study Start: 2025-08-17
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-02
• Last Update Posted: 2025-09-04
• Primary Completion: 2026-10
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
JADE101	JADE101	Subcutaneous (SC) injection of JADE101
Placebo	Placebo	Subcutaneous (SC) injection of placebo

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability of Single Ascending Doses of JADE101 in Healthy Participants	Day 1 through 48 weeks	Incidence of treatment-emergent adverse events

Secondary Outcome Measures

Name	Time	Method
Tmax	Day 1 through 48 weeks	Time to reach Cmax
Cmax	Day 1 through 48 weeks	Maximum observed serum concentration
AUClast	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
T1/2	Day 1 through 48 weeks	Apparent first-order terminal elimination half-life

Trial Locations

Locations (1)

NZCR; 🇳🇿 Auckland, New Zealand