Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NXT007 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf) of NXT007 | At prespecified timepoints from Day 1 until Day 253 | |
| Maximum Observed Plasma Concentration (Cmax) of NXT007 | At prespecified timepoints from Day 1 until Day 253 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Time to Maximum Observed Plasma Concentration (tmax) of NXT007 | At prespecified timepoints from Day 1 until Day 253 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Zealand Clinical Research - Auckland | Auckland | 1010 | New Zealand | |||
| New Zealand Clinical Research - Christchurch |
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Apparent Terminal Half-Life (t1/2) of NXT007 | At prespecified timepoints from Day 1 until Day 253 |
| Apparent Clearance (CL/F) of NXT007 SC Administration | At prespecified timepoints from Day 1 until Day 253 |
| Total Body Clearance (CL) of NXT007 IV Administration | At prespecified timepoints from Day 1 until Day 253 |
| Volume of Distribution at Steady State of NXT007 IV Administration | At prespecified timepoints from Day 1 until Day 253 |
| Incidence and Severity of Adverse Events | 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 | From the single dose of study treatment (Day 1) until study completion (Day 253) |
| Number of Participants with Abnormal Laboratory Values in Hematology Parameters | From the single dose of study treatment (Day 1) until study completion (Day 253) |
| 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 |
| 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 |
| 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 |
| 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 |
| Change from Baseline in Heart Rate at Specified Timepoints, as Measured by Electrocardiogram | 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 | Baseline, Days 1, 2, 8, 22, 43, 71, 141, and 253 |
| 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 |
| Change from Baseline in the Maximum Concentration of Thrombin Generated at Specified Timepoints | 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 | From Baseline until Day 253 |
| Christchurch |
| 8011 |
| New Zealand |