NCT06304961

A Study to Investigate Relative Bioavailability of Two Different Dosage Forms for Tozorakimab Via Subcutaneous Administration in Healthy Volunteers

A Randomised, Single-dose, Parallel Group Study in Healthy Volunteers to Assess the Relative Bioavailability of Two Different Dosage Forms for Tozorakimab Via Subcutaneous Administration

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The study will assess the relative bioavailability between two dosage forms of tozorakimab (test dosage form and reference dosage form) and to assess the pharmacokinetic (PK) profiles of both dosage forms.

Detailed description

This is a phase I, randomised, open-label, single-dose, single-centre, parallel group study investigating the relative bioavailability of two dosage forms of tozorakimab (test dosage form and reference dosage form). The study will comprise of: 1. A screening period of 28 days 2. A Treatment period of 1 day 3. Ambulatory visits on scheduled days c. A final follow-up visit on Day 113 (Week 16)

Conditions

• Healthy Participants

Interventions

Type	Name	Description
BIOLOGICAL	Tozorakimab	Tozorakimab will be administered as a single SC dose on Day 1.

Timeline

• Start date: 2024-04-08
• Primary completion: 2024-09-09
• Completion: 2024-09-09
• First posted: 2024-03-12
• Last updated: 2024-09-19

Locations

1 site across 1 country: Germany