NCT06189508

A Study to Evaluate Single Subcutaneous Doses of NXT007 Among Injection Sites Abdomen, Upper Arm, and Thigh in Healthy Male Participants

An Open-Label, Parallel-Group Phase I Study to Evaluate the Relative and Absolute Bioavailability of Single Subcutaneous Doses of NXT007 Among Injection Sites Abdomen, Upper Arm, and Thigh in Healthy Male Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a Phase I, open-label, non-randomized, parallel-group, single-dose study in healthy adult male participants. The aim is to investigate the relative bioavailability (rBA) of NXT007 among subcutaneous (SC) injection sites (abdomen, upper arm, and thigh) and the absolute bioavailability (aBA) of SC NXT007 administration. In addition, the pharmacodynamic, safety, tolerability, and immunogenicity of a single dose of NXT007 following SC or intravenous (IV) administration are assessed.

Conditions

• Healthy Male Participants

Interventions

Type	Name	Description
DRUG	NXT007	In all groups, the NXT007 single dose administration will occur in the morning of Day 1 under fasted conditions. Study treatment will occur via the route of administration and at the site of injection specified for each group.

Timeline

• Start date: 2024-02-14
• Primary completion: 2024-12-22
• Completion: 2024-12-22
• First posted: 2024-01-03
• Last updated: 2025-01-15

Locations

2 sites across 1 country: New Zealand