A Study to Evaluate Single Subcutaneous Doses of NXT007 Among Injection Sites Abdomen, Upper Arm, and Thigh in Healthy Male Participants
- Registration Number
- NCT06189508
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 48
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B: Single NXT007 SC Injection Into Upper Arm NXT007 - C: Single NXT007 SC Injection Into Thigh NXT007 - D: Single NXT007 IV Infusion NXT007 - A: Single NXT007 SC Injection Into Abdomen NXT007 -
- Primary Outcome Measures
Name Time Method 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
Name Time Method Incidence and Severity of Adverse Events From the single dose of study treatment (Day 1) until study completion (Day 253) Volume of Distribution at Steady State of NXT007 IV Administration 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 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 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 the Maximum Concentration of Thrombin Generated at Specified Timepoints Baseline, Days 1, 18, 20, and 22 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 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 Prevalence of Anti-Drug Antibodies (ADAs) to NXT007 at Baseline and Incidence of ADAs to NXT007 During the Study From Baseline until Day 253
Trial Locations
- Locations (2)
New Zealand Clinical Research - Auckland
🇳🇿Auckland, New Zealand
New Zealand Clinical Research - Christchurch
🇳🇿Christchurch, New Zealand