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

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Male Participants

Treatments: Drug: NXT007

Study type: Interventional

Funder types: Industry

Identifiers

NCT06189508

BP45057

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 4 patient groups

A: Single NXT007 SC Injection Into Abdomen

Experimental group

Treatment:

Drug: NXT007

B: Single NXT007 SC Injection Into Upper Arm

Experimental group

Treatment:

Drug: NXT007

C: Single NXT007 SC Injection Into Thigh

Experimental group

Treatment:

Drug: NXT007

D: Single NXT007 IV Infusion

Experimental group

Treatment:

Drug: NXT007