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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06189508




Registration number
NCT06189508
Ethics application status
Date submitted
11/12/2023
Date registered
3/01/2024

Titles & IDs
Public title
A Study to Evaluate Single Subcutaneous Doses of NXT007 Among Injection Sites Abdomen, Upper Arm, and Thigh in Healthy Male Participants
Scientific 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
Secondary ID [1] 0 0
BP45057
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Male Participants 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - NXT007

Experimental: A: Single NXT007 SC Injection Into Abdomen -

Experimental: B: Single NXT007 SC Injection Into Upper Arm -

Experimental: C: Single NXT007 SC Injection Into Thigh -

Experimental: D: Single NXT007 IV Infusion -


Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf) of NXT007
Timepoint [1] 0 0
At prespecified timepoints from Day 1 until Day 253
Primary outcome [2] 0 0
Maximum Observed Plasma Concentration (Cmax) of NXT007
Timepoint [2] 0 0
At prespecified timepoints from Day 1 until Day 253
Secondary outcome [1] 0 0
Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUC0-last) of NXT007
Timepoint [1] 0 0
At prespecified timepoints from Day 1 until Day 253
Secondary outcome [2] 0 0
Time to Maximum Observed Plasma Concentration (tmax) of NXT007
Timepoint [2] 0 0
At prespecified timepoints from Day 1 until Day 253
Secondary outcome [3] 0 0
Apparent Terminal Half-Life (t1/2) of NXT007
Timepoint [3] 0 0
At prespecified timepoints from Day 1 until Day 253
Secondary outcome [4] 0 0
Apparent Clearance (CL/F) of NXT007 SC Administration
Timepoint [4] 0 0
At prespecified timepoints from Day 1 until Day 253
Secondary outcome [5] 0 0
Total Body Clearance (CL) of NXT007 IV Administration
Timepoint [5] 0 0
At prespecified timepoints from Day 1 until Day 253
Secondary outcome [6] 0 0
Volume of Distribution at Steady State of NXT007 IV Administration
Timepoint [6] 0 0
At prespecified timepoints from Day 1 until Day 253
Secondary outcome [7] 0 0
Incidence and Severity of Adverse Events
Timepoint [7] 0 0
From the single dose of study treatment (Day 1) until study completion (Day 253)
Secondary outcome [8] 0 0
Number of Participants with Abnormal Laboratory Values in Clinical Chemistry Parameters
Timepoint [8] 0 0
From the single dose of study treatment (Day 1) until study completion (Day 253)
Secondary outcome [9] 0 0
Number of Participants with Abnormal Laboratory Values in Hematology Parameters
Timepoint [9] 0 0
From the single dose of study treatment (Day 1) until study completion (Day 253)
Secondary outcome [10] 0 0
Change from Baseline in Pulse Rate at Specified Timepoints
Timepoint [10] 0 0
Baseline, Days 1, 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, 85, 113, 141, 169, 197, 225, and 253
Secondary outcome [11] 0 0
Change from Baseline in Tympanic Temperature at Specified Timepoints
Timepoint [11] 0 0
Baseline, Days 1, 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, 85, 113, 141, 169, 197, 225, and 253
Secondary outcome [12] 0 0
Change from Baseline in Systolic Blood Pressure at Specified Timepoints
Timepoint [12] 0 0
Baseline, Days 1, 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, 85, 113, 141, 169, 197, 225, and 253
Secondary outcome [13] 0 0
Change from Baseline in Diastolic Blood Pressure at Specified Timepoints
Timepoint [13] 0 0
Baseline, Days 1, 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, 85, 113, 141, 169, 197, 225, and 253
Secondary outcome [14] 0 0
Change from Baseline in Heart Rate at Specified Timepoints, as Measured by Electrocardiogram
Timepoint [14] 0 0
Baseline, Days 1, 2, 8, 22, 43, 71, 141, and 253
Secondary outcome [15] 0 0
Change from Baseline in RR, PR, QRS, QT, and QTcF Intervals at Specified Timepoints, as Measured by Electrocardiogram
Timepoint [15] 0 0
Baseline, Days 1, 2, 8, 22, 43, 71, 141, and 253
Secondary outcome [16] 0 0
Change from Baseline in Activated Partial Thromboplastin Time (aPTT) at Specified Timepoints
Timepoint [16] 0 0
Baseline, Days 1, 2, 8, 15, 18, 20, 22, 29, 43, 57, 71, 85, 113, 141, 169, 197, 225, and 253
Secondary outcome [17] 0 0
Change from Baseline in the Maximum Concentration of Thrombin Generated at Specified Timepoints
Timepoint [17] 0 0
Baseline, Days 1, 18, 20, and 22
Secondary outcome [18] 0 0
Prevalence of Anti-Drug Antibodies (ADAs) to NXT007 at Baseline and Incidence of ADAs to NXT007 During the Study
Timepoint [18] 0 0
From Baseline until Day 253

Eligibility
Key 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
Minimum age
18 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Other
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/02/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/01/2025
Actual
Sample size
Target
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
For eligible studies, qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical-trials/data-sharing/).


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06189508