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Completed

NCT Number: NCT06189508

A Study to Evaluate 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.

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Key information

Conditions

Healthy Male Participants

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

New Zealand Clinical Research - Auckland, Auckland, New Zealand

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: RO7589655

Primary outcomes

  1. 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

  2. Maximum Observed Plasma Concentration (Cmax) of NXT007

    Time frame: At prespecified timepoints from Day 1 until Day 253

Secondary outcomes

  1. Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUC0-last) of NXT007

    Time frame: At prespecified timepoints from Day 1 until Day 253

  2. Time to Maximum Observed Plasma Concentration (tmax) of NXT007

    Time frame: At prespecified timepoints from Day 1 until Day 253

  3. Apparent Terminal Half-Life (t1/2) of NXT007

    Time frame: At prespecified timepoints from Day 1 until Day 253

  4. Apparent Clearance (CL/F) of NXT007 SC Administration

    Time frame: At prespecified timepoints from Day 1 until Day 253

  5. Total Body Clearance (CL) of NXT007 IV Administration

    Time frame: At prespecified timepoints from Day 1 until Day 253

  6. Volume of Distribution at Steady State of NXT007 IV Administration

    Time frame: At prespecified timepoints from Day 1 until Day 253

  7. Incidence and Severity of Adverse Events

    Time frame: From the single dose of study treatment (Day 1) until study completion (Day 253)

  8. Number of Participants with Abnormal Laboratory Values in Clinical Chemistry Parameters

    Time frame: From the single dose of study treatment (Day 1) until study completion (Day 253)

  9. Number of Participants with Abnormal Laboratory Values in Hematology Parameters

    Time frame: From the single dose of study treatment (Day 1) until study completion (Day 253)

  10. Change from Baseline in Pulse Rate at Specified Timepoints

    Time frame: Baseline, Days 1, 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, 85, 113, 141, 169, 197, 225, and 253

  11. Change from Baseline in Tympanic Temperature at Specified Timepoints

    Time frame: Baseline, Days 1, 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, 85, 113, 141, 169, 197, 225, and 253

  12. Change from Baseline in Systolic Blood Pressure at Specified Timepoints

    Time frame: Baseline, Days 1, 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, 85, 113, 141, 169, 197, 225, and 253

  13. Change from Baseline in Diastolic Blood Pressure at Specified Timepoints

    Time frame: Baseline, Days 1, 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, 85, 113, 141, 169, 197, 225, and 253

  14. Change from Baseline in Heart Rate at Specified Timepoints, as Measured by Electrocardiogram

    Time frame: Baseline, Days 1, 2, 8, 22, 43, 71, 141, and 253

  15. Change from Baseline in RR, PR, QRS, QT, and QTcF Intervals at Specified Timepoints, as Measured by Electrocardiogram

    Time frame: Baseline, Days 1, 2, 8, 22, 43, 71, 141, and 253

  16. Change from Baseline in Activated Partial Thromboplastin Time (aPTT) at Specified Timepoints

    Time frame: Baseline, Days 1, 2, 8, 15, 18, 20, 22, 29, 43, 57, 71, 85, 113, 141, 169, 197, 225, and 253

  17. Change from Baseline in the Maximum Concentration of Thrombin Generated at Specified Timepoints

    Time frame: Baseline, Days 1, 18, 20, and 22

  18. Prevalence of Anti-Drug Antibodies (ADAs) to NXT007 at Baseline and Incidence of ADAs to NXT007 During the Study

    Time frame: From Baseline until Day 253

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 3, 2024
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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