A Phase 1 Study of JADE101 in Healthy Participants

NCT07059312 | Active Not Recruiting Phase 1

• 1 other identifier: JADE101-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

JADE101

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability of Single Ascending Doses of JADE101 in Healthy Participants

  Incidence of treatment-emergent adverse events

  Day 1 through 48 weeks

Secondary Outcomes (4)

• Cmax

  Day 1 through 48 weeks

• Tmax

  Day 1 through 48 weeks

• AUClast

  Day 1 through 48 weeks

• T1/2

  Day 1 through 48 weeks

Study Arms (2)

JADE101

EXPERIMENTAL

Subcutaneous (SC) injection of JADE101

Drug: JADE101

Placebo

PLACEBO COMPARATOR

Subcutaneous (SC) injection of placebo

Drug: Placebo

Interventions

JADE101 DRUG

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

JADE101

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female participants 18-55 years of age, inclusive
• A body weight between 50-100 kg and a body mass index (BMI) between 18.0 - 32.0 kg/m2 (all inclusive) at screening
• Willing and able to comply with the study site stay, scheduled visits, and study procedures
• 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

You may not qualify if:

• Harmful alcohol use
• Smoking/vaping or heavy tobacco use within 2 years prior to screening
• Known history of abuse of illicit drugs
• Nursing, lactating or pregnant, or who have plans to become pregnant during the study
• Known history of clinically significant disease
• Known history of immunodeficiency disorder
• History of clinically significant allergic reactions or hypersensitivity

Sponsors & Collaborators

• Jade Biosciences, Inc.: lead

Study Sites (1)

NZCR

Auckland, New Zealand

Location

Study Officials

• Li Li, MD

  Jade Biosciences, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 10, 2025
• Study Start: August 17, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)