A Study to Evaluate Single Subcutaneous Doses of NXT007 Among Injection Sites Abdomen, Upper Arm, and Thigh in Healthy Male Participants
- Sponsor
- Hoffmann-La Roche
- Study ID
- NCT06189508
- Phase
- PHASE1
- Status
- Completed
Conditions
- Healthy Male Participants
Eligibility Criteria
- Sex
- MALE
- Age
- 18 Years - 45 Years
- Healthy Volunteers
- Accepted
Interventions
- NXT007 — DRUGIn 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.
Study Details
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.
Key Dates
- Start date
- Feb 14, 2024
- Status verified
- Jan 2025
- Primary completion
- Dec 22, 2024
- Completion
- Dec 22, 2024
Study Design
- Enrollment
- 48 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: A: Single NXT007 SC Injection Into Abdomen
- Experimental: B: Single NXT007 SC Injection Into Upper Arm
- Experimental: C: Single NXT007 SC Injection Into Thigh
- Experimental: D: Single NXT007 IV Infusion
Primary Outcome Measure
Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf) of NXT007 [ Time Frame: At prespecified timepoints from Day 1 until Day 253 ]