Status:
COMPLETED
A Study to Evaluate Single Subcutaneous Doses of NXT007 Among Injection Sites Abdomen, Upper Arm, and Thigh in Healthy Male Participants
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Healthy Male Participants
Eligibility:
MALE
18-45 years
Phase:
PHASE1
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 subcut...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2024
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06189508
Start Date
February 14 2024
End Date
December 22 2024
Last Update
January 15 2025
Active Locations (2)
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1
New Zealand Clinical Research - Auckland
Auckland, New Zealand, 1010
2
New Zealand Clinical Research - Christchurch
Christchurch, New Zealand, 8011