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

NCT06189508 | Completed Phase 1

• 1 other identifier: BP45057
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (18)

• 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

Study Arms (4)

A: Single NXT007 SC Injection Into Abdomen

EXPERIMENTAL

Drug: NXT007

B: Single NXT007 SC Injection Into Upper Arm

EXPERIMENTAL

Drug: NXT007

C: Single NXT007 SC Injection Into Thigh

EXPERIMENTAL

Drug: NXT007

D: Single NXT007 IV Infusion

EXPERIMENTAL

Drug: NXT007

Interventions

NXT007 DRUG

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.

Also known as: RO7589655

A: Single NXT007 SC Injection Into Abdomen; B: Single NXT007 SC Injection Into Upper Arm; C: Single NXT007 SC Injection Into Thigh; D: Single NXT007 IV Infusion

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (2)

New Zealand Clinical Research - Auckland

Auckland, 1010, New Zealand

Location

New Zealand Clinical Research - Christchurch

Christchurch, 8011, New Zealand

Location

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: January 3, 2024
• Study Start: February 14, 2024
• Primary Completion: December 22, 2024
• Study Completion: December 22, 2024
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (2)