Healthy Male ParticipantsPhase 1NCT06189508
A Study to Evaluate Single Subcutaneous Doses of NXT007 Among Injection Sites Abdomen, Upper Arm, and Thigh in Healthy Male Participants
A Phase 1 study testing NXT007 in people with Healthy Male Participants, run by Hoffmann-La Roche at 2 sites in New Zealand.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Participants
- What is being tested?
- NXT007
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesNew Zealand
- Study dates
- 14 Feb 2024to 22 Dec 2024
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
2 sites in 1 country.
New Zealand2 sites
New Zealand Clinical Research - Auckland
Auckland, 1010
New Zealand Clinical Research - Christchurch
Christchurch, 8011
About this study
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
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.
- Conditions
- Healthy Male Participants
- Being tested
- NXT007
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NXT007Drug
Also called RO7589655
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.
| Study group | Role | What they receive |
|---|---|---|
| A: Single NXT007 SC Injection Into Abdomen | Experimental | Not described Receives: Drug: NXT007 |
| B: Single NXT007 SC Injection Into Upper Arm | Experimental | Not described Receives: Drug: NXT007 |
| C: Single NXT007 SC Injection Into Thigh | Experimental | Not described Receives: Drug: NXT007 |
| D: Single NXT007 IV Infusion | Experimental | Not described Receives: Drug: NXT007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf) of NXT007
Measured: At prespecified timepoints from Day 1 until Day 253
Maximum Observed Plasma Concentration (Cmax) of NXT007
Measured: At prespecified timepoints from Day 1 until Day 253
Secondary outcomes (18)
Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUC0-last) of NXT007
Measured: At prespecified timepoints from Day 1 until Day 253
Time to Maximum Observed Plasma Concentration (tmax) of NXT007
Measured: At prespecified timepoints from Day 1 until Day 253
Apparent Terminal Half-Life (t1/2) of NXT007
Measured: At prespecified timepoints from Day 1 until Day 253
Apparent Clearance (CL/F) of NXT007 SC Administration
Measured: At prespecified timepoints from Day 1 until Day 253
Total Body Clearance (CL) of NXT007 IV Administration
Measured: At prespecified timepoints from Day 1 until Day 253
Volume of Distribution at Steady State of NXT007 IV Administration
Measured: At prespecified timepoints from Day 1 until Day 253
Incidence and Severity of Adverse Events
Measured: From the single dose of study treatment (Day 1) until study completion (Day 253)
Number of Participants with Abnormal Laboratory Values in Clinical Chemistry Parameters
Measured: From the single dose of study treatment (Day 1) until study completion (Day 253)
Number of Participants with Abnormal Laboratory Values in Hematology Parameters
Measured: From the single dose of study treatment (Day 1) until study completion (Day 253)
Change from Baseline in Pulse Rate at Specified Timepoints
Measured: Baseline, Days 1, 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, 85, 113, 141, 169, 197, 225, and 253
Change from Baseline in Tympanic Temperature at Specified Timepoints
Measured: Baseline, Days 1, 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, 85, 113, 141, 169, 197, 225, and 253
Change from Baseline in Systolic Blood Pressure at Specified Timepoints
Measured: Baseline, Days 1, 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, 85, 113, 141, 169, 197, 225, and 253
Change from Baseline in Diastolic Blood Pressure at Specified Timepoints
Measured: Baseline, Days 1, 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, 85, 113, 141, 169, 197, 225, and 253
Change from Baseline in Heart Rate at Specified Timepoints, as Measured by Electrocardiogram
Measured: Baseline, Days 1, 2, 8, 22, 43, 71, 141, and 253
Change from Baseline in RR, PR, QRS, QT, and QTcF Intervals at Specified Timepoints, as Measured by Electrocardiogram
Measured: Baseline, Days 1, 2, 8, 22, 43, 71, 141, and 253
Change from Baseline in Activated Partial Thromboplastin Time (aPTT) at Specified Timepoints
Measured: Baseline, Days 1, 2, 8, 15, 18, 20, 22, 29, 43, 57, 71, 85, 113, 141, 169, 197, 225, and 253
Change from Baseline in the Maximum Concentration of Thrombin Generated at Specified Timepoints
Measured: Baseline, Days 1, 18, 20, and 22
Prevalence of Anti-Drug Antibodies (ADAs) to NXT007 at Baseline and Incidence of ADAs to NXT007 During the Study
Measured: From Baseline until Day 253
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start14 Feb 2024
- Primary completion22 Dec 2024
- Study completion22 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male ParticipantsStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189508
- Sponsor's protocol ID
- BP45057
- Status last verified
- Jan 2025
- First submitted
- 11 Dec 2023
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing