A Phase 1 interventional study of NXT007 in Healthy Male Participants, sponsored by Hoffmann-La Roche. Completed at 2 sites in New Zealand. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-15.
Sponsored by Hoffmann-La Roche · Phase 1, Interventional, and Basic science
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.
Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: NXT007
Drug: NXT007
Drug: NXT007
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.
Also known as: RO7589655
Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf) of NXT007
Time frame: At prespecified timepoints from Day 1 until Day 253
Maximum Observed Plasma Concentration (Cmax) of NXT007
Time frame: At prespecified timepoints from Day 1 until Day 253
Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUC0-last) of NXT007
Time frame: At prespecified timepoints from Day 1 until Day 253
Time to Maximum Observed Plasma Concentration (tmax) of NXT007
Time frame: At prespecified timepoints from Day 1 until Day 253
Apparent Terminal Half-Life (t1/2) of NXT007
Time frame: At prespecified timepoints from Day 1 until Day 253
Apparent Clearance (CL/F) of NXT007 SC Administration
Time frame: At prespecified timepoints from Day 1 until Day 253
Total Body Clearance (CL) of NXT007 IV Administration
Time frame: At prespecified timepoints from Day 1 until Day 253
Volume of Distribution at Steady State of NXT007 IV Administration
Time frame: At prespecified timepoints from Day 1 until Day 253
Incidence and Severity of Adverse Events
Time frame: 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
Time frame: From the single dose of study treatment (Day 1) until study completion (Day 253)
Number of Participants with Abnormal Laboratory Values in Hematology Parameters
Time frame: From the single dose of study treatment (Day 1) until study completion (Day 253)
Change from Baseline in Pulse Rate at Specified Timepoints
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, Days 1, 2, 8, 22, 43, 71, 141, and 253
Change from Baseline in Activated Partial Thromboplastin Time (aPTT) at Specified Timepoints
Time frame: 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
Time frame: 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
Time frame: From Baseline until Day 253
Plan to share: 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
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Hoffmann-La Roche