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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Male Participants
• Intervention / Treatment: Drug: NXT007

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• New Zealand
  • Auckland, New Zealand, 1010
    • New Zealand Clinical Research - Auckland
  • Christchurch, New Zealand, 8011
    • New Zealand Clinical Research - Christchurch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Overtly healthy as determined by medical evaluation that includes medical history, physical examination, vital signs, laboratory tests, and 12-lead ECG
• Body mass index (BMI) within the range of 18.5 to 30.0 kg/m^2
• Agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm

Exclusion Criteria:

• History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, immunological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatment; or interfering with the interpretation of data
• History of allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies; or known hypersensitivity to any constituent of the product
• Clinically relevant medical history and/or family history or signs of thromboembolic disease such as deep vein thrombosis
• FVIII activity ≥120 International Units per decilitre (IU/dL) at screening
• Clinically significant abnormality on electrocardiogram (ECG) at screening such as QTcF after 10-minute supine rest >450 milliseconds (ms); marked resting bradycardia (mean heart rate <40 beats per minute [bpm]); marked resting tachycardia (mean heart rate >100 bpm); or any other clinically significant ECG abnormality
• Supine systolic blood pressure at screening ≥140 millimetres of mercury (mm Hg) or <90 mm Hg or supine diastolic blood pressure at screening ≥90 mm Hg or <40 mm Hg
• Clinically significant abnormality on protein C activity (chromogenic assay), activated protein C resistance test, protein S free antigen, and/or antithrombin III activity levels
• Poor peripheral venous access
• Any other reason that, in the judgment of the investigator, would render the participants unsuitable for study participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A: Single NXT007 SC Injection Into Abdomen	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.; Other Names: RO7589655
Experimental: B: Single NXT007 SC Injection Into Upper Arm	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.; Other Names: RO7589655
Experimental: C: Single NXT007 SC Injection Into Thigh	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.; Other Names: RO7589655
Experimental: D: Single NXT007 IV Infusion	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.; Other Names: RO7589655

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf) of NXT007	At prespecified timepoints from Day 1 until Day 253
Maximum Observed Plasma Concentration (Cmax) of NXT007	At prespecified timepoints from Day 1 until Day 253

Secondary Outcome Measures

Outcome Measure	Time Frame
Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUC0-last) of NXT007	At prespecified timepoints from Day 1 until Day 253
Time to Maximum Observed Plasma Concentration (tmax) of NXT007	At prespecified timepoints from Day 1 until Day 253
Apparent Terminal Half-Life (t1/2) of NXT007	At prespecified timepoints from Day 1 until Day 253
Apparent Clearance (CL/F) of NXT007 SC Administration	At prespecified timepoints from Day 1 until Day 253
Total Body Clearance (CL) of NXT007 IV Administration	At prespecified timepoints from Day 1 until Day 253
Volume of Distribution at Steady State of NXT007 IV Administration	At prespecified timepoints from Day 1 until Day 253
Incidence and Severity of Adverse Events	From the single dose of study treatment (Day 1) until study completion (Day 253)
Number of Participants with Abnormal Laboratory Values in Clinical Chemistry Parameters	From the single dose of study treatment (Day 1) until study completion (Day 253)
Number of Participants with Abnormal Laboratory Values in Hematology Parameters	From the single dose of study treatment (Day 1) until study completion (Day 253)
Change from Baseline in Pulse Rate at Specified Timepoints	Baseline, Days 1, 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, 85, 113, 141, 169, 197, 225, and 253
Change from Baseline in Tympanic Temperature at Specified Timepoints	Baseline, Days 1, 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, 85, 113, 141, 169, 197, 225, and 253
Change from Baseline in Systolic Blood Pressure at Specified Timepoints	Baseline, Days 1, 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, 85, 113, 141, 169, 197, 225, and 253
Change from Baseline in Diastolic Blood Pressure at Specified Timepoints	Baseline, Days 1, 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, 85, 113, 141, 169, 197, 225, and 253
Change from Baseline in Heart Rate at Specified Timepoints, as Measured by Electrocardiogram	Baseline, Days 1, 2, 8, 22, 43, 71, 141, and 253
Change from Baseline in RR, PR, QRS, QT, and QTcF Intervals at Specified Timepoints, as Measured by Electrocardiogram	Baseline, Days 1, 2, 8, 22, 43, 71, 141, and 253
Change from Baseline in Activated Partial Thromboplastin Time (aPTT) at Specified Timepoints	Baseline, Days 1, 2, 8, 15, 18, 20, 22, 29, 43, 57, 71, 85, 113, 141, 169, 197, 225, and 253
Change from Baseline in the Maximum Concentration of Thrombin Generated at Specified Timepoints	Baseline, Days 1, 18, 20, and 22
Prevalence of Anti-Drug Antibodies (ADAs) to NXT007 at Baseline and Incidence of ADAs to NXT007 During the Study	From Baseline until Day 253

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2024
• Primary Completion (Actual): December 22, 2024
• Study Completion (Actual): December 22, 2024

Study Registration Dates

• First Submitted: December 11, 2023
• First Submitted That Met QC Criteria: December 19, 2023
• First Posted (Actual): January 3, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 14, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: BP45057

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No