A Study to Evaluate Single Subcutaneous Doses of NXT007 Among Injection Sites Abdomen, Upper Arm, and Thigh in Healthy Male Participants
- Conditions
- Healthy Male Participants
- Registration Number
- NCT06189508
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Overtly healthy as determined by medical evaluation that includes medical history,<br> physical examination, vital signs, laboratory tests, and 12-lead ECG<br><br> - Body mass index (BMI) within the range of 18.5 to 30.0 kg/m^2<br><br> - Agreement to remain abstinent (refrain from heterosexual intercourse) or use a<br> condom, and agree to refrain from donating sperm<br><br>Exclusion Criteria:<br><br> - History or presence of cardiovascular, respiratory, hepatic, renal,<br> gastrointestinal, endocrine, hematological, immunological, or neurological disorders<br> capable of significantly altering the absorption, metabolism, or elimination of<br> drugs; constituting a risk when taking the study treatment; or interfering with the<br> interpretation of data<br><br> - History of allergic or anaphylactic reactions to human, humanized, or murine<br> monoclonal antibodies; or known hypersensitivity to any constituent of the product<br><br> - Clinically relevant medical history and/or family history or signs of thromboembolic<br> disease such as deep vein thrombosis<br><br> - FVIII activity =120 International Units per decilitre (IU/dL) at screening<br><br> - Clinically significant abnormality on electrocardiogram (ECG) at screening such as<br> QTcF after 10-minute supine rest >450 milliseconds (ms); marked resting bradycardia<br> (mean heart rate <40 beats per minute [bpm]); marked resting tachycardia (mean heart<br> rate >100 bpm); or any other clinically significant ECG abnormality<br><br> - Supine systolic blood pressure at screening =140 millimetres of mercury (mm Hg) or<br> <90 mm Hg or supine diastolic blood pressure at screening =90 mm Hg or <40 mm Hg<br><br> - Clinically significant abnormality on protein C activity (chromogenic assay),<br> activated protein C resistance test, protein S free antigen, and/or antithrombin III<br> activity levels<br><br> - Poor peripheral venous access<br><br> - Any other reason that, in the judgment of the investigator, would render the<br> participants unsuitable for study participation
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf) of NXT007;Maximum Observed Plasma Concentration (Cmax) of NXT007
- Secondary Outcome Measures
Name Time Method