A Phase 1 Study of JADE101 in Healthy Participants

A Phase 1, Randomized, Double-blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JADE101 Administered Subcutaneously in Healthy Volunteers

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: JADE101; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• New Zealand
  • Auckland, New Zealand
    • NZCR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JADE101; Subcutaneous (SC) injection of JADE101	Drug: JADE101; JADE101 is supplied as sterile solution to be administered by SC injection.
Placebo Comparator: Placebo; Subcutaneous (SC) injection of placebo	Drug: Placebo; Placebo solution to be administered at a matching volume by SC injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability of Single Ascending Doses of JADE101 in Healthy Participants	Incidence of treatment-emergent adverse events	Day 1 through 48 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum observed serum concentration	Day 1 through 48 weeks
Tmax	Time to reach Cmax	Day 1 through 48 weeks
AUClast	The area under the concentration-time curve from time zero to the time of the last observed quantifiable (non-zero) concentration	Day 1 through 48 weeks
T1/2	Apparent first-order terminal elimination half-life	Day 1 through 48 weeks

Collaborators and Investigators

• Sponsor: Jade Biosciences, Inc.
• Investigators: Study Director: Li Li, MD, Jade Biosciences, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: June 27, 2025
• First Submitted That Met QC Criteria: July 9, 2025
• First Posted (Actual): July 10, 2025

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: JADE101
• Additional Relevant MeSH Terms: Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: JADE101-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No