NCT07059312

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Jade Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	JADE101	JADE101 is supplied as sterile solution to be administered by SC injection.
DRUG	Placebo	Placebo solution to be administered at a matching volume by SC injection.

Timeline

• Start date: 2025-08-17
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2025-07-10
• Last updated: 2025-12-18

Locations

1 site across 1 country: New Zealand