NCT05937581

First-In-Human Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Escalating Single And Multiple Doses Of CSL040 In Healthy Subjects

A Phase 1, Double-Blind (Sponsor-Unblinded), Placebo-Controlled, Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Single And Multiple Doses Of CSL040 In Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

First-In-Human Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Escalating Single And Multiple Doses Of CSL040 In Healthy Subjects

Conditions

• Complement-mediated Disorders

Interventions

Type	Name	Description
DRUG	CSL040	IV Administration
DRUG	Placebo	0.9% w/v NaCI, IV Administration

Timeline

• Start date: 2023-09-28
• Primary completion: 2025-12-04
• Completion: 2025-12-04
• First posted: 2023-07-10
• Last updated: 2026-02-03

Locations

1 site across 1 country: Australia