NCT06877611

A Phase 1 Study of S-4321

A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single and Multiple Ascending Dose Trial of S-4321 in Healthy Volunteers

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Seismic Therapeutic AU Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is the first-in-human study of S-4321 designed to provide safety, tolerability, pharmacokinetic, and pharmacodynamic data in healthy volunteers.

Detailed description

This is a randomized, placebo-controlled, double-blind, study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics of S-4321 administered to healthy adult participants. This study will be conducted in two parts, Part 1 (single ascending dose, SAD) and Part 2 (multiple ascending doses, MAD).

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	S-4321	S-4321 via subcutaneous or intravenous administration
OTHER	Placebo	Placebo via subcutaneous or intravenous administration.

Timeline

• Start date: 2025-04-03
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2025-03-14
• Last updated: 2025-04-15

Locations

1 site across 1 country: Australia