NCT07375498

Safety and Pharmacokinetics of Rescue Liposome in Healthy Adults

Phase 1 Clinical Study of the Safety and Pharmacokinetics of Rescue Liposome in Healthy Adult Participants

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Cristália Produtos Químicos Farmacêuticos Ltda. · Industry
• Sex: Male
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1 study to assess the safety and tolerability of the liposomal product in healthy participants.

Detailed description

This is a Phase 1 clinical trial consisting of a dose-escalation and dose-expansion study to evaluate the safety, clinical tolerability, and pharmacokinetics of the intravenous liposomal dispersion product in healthy participants.

Conditions

• Healthy Adult
• Overdose Antidote

Interventions

Type	Name	Description
DRUG	liposome dispersion	liposome rescue

Timeline

• Start date: 2026-08-20
• Primary completion: 2026-12-20
• Completion: 2027-02-20
• First posted: 2026-01-29
• Last updated: 2026-02-04

Locations

1 site across 1 country: Brazil