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

Healthy Male Participants Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06189508
• Other study ID #: BP45057
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: February 14, 2024
• Est. completion date: January 29, 2025

Study information

• Verified date: May 2024
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: January 29, 2025
• Est. primary completion date: January 29, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Male Participants

Intervention

Drug:
• NXT007
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.

Locations

Country	Name	City	State
New Zealand	New Zealand Clinical Research - Auckland	Auckland
New Zealand	New Zealand Clinical Research - Christchurch	Christchurch

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf) of NXT007		At prespecified timepoints from Day 1 until Day 253
Primary	Maximum Observed Plasma Concentration (Cmax) of NXT007		At prespecified timepoints from Day 1 until Day 253
Secondary	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
Secondary	Time to Maximum Observed Plasma Concentration (tmax) of NXT007		At prespecified timepoints from Day 1 until Day 253
Secondary	Apparent Terminal Half-Life (t1/2) of NXT007		At prespecified timepoints from Day 1 until Day 253
Secondary	Apparent Clearance (CL/F) of NXT007 SC Administration		At prespecified timepoints from Day 1 until Day 253
Secondary	Total Body Clearance (CL) of NXT007 IV Administration		At prespecified timepoints from Day 1 until Day 253
Secondary	Volume of Distribution at Steady State of NXT007 IV Administration		At prespecified timepoints from Day 1 until Day 253
Secondary	Incidence and Severity of Adverse Events		From the single dose of study treatment (Day 1) until study completion (Day 253)
Secondary	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)
Secondary	Number of Participants with Abnormal Laboratory Values in Hematology Parameters		From the single dose of study treatment (Day 1) until study completion (Day 253)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change from Baseline in Heart Rate at Specified Timepoints, as Measured by Electrocardiogram		Baseline, Days 1, 2, 8, 22, 43, 71, 141, and 253
Secondary	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
Secondary	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
Secondary	Change from Baseline in the Maximum Concentration of Thrombin Generated at Specified Timepoints		Baseline, Days 1, 18, 20, and 22
Secondary	Prevalence of Anti-Drug Antibodies (ADAs) to NXT007 at Baseline and Incidence of ADAs to NXT007 During the Study		From Baseline until Day 253