Trial · NCT07904689
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants with adverse events | From informed consent through the end of the trial (EOT), up to approximately 29 months. | Number of participants with adverse events, including serious adverse events, summarized by severity and relationship to study intervention in Parts 1 and 2. |
| Primary | Number of participants with clinically significant vital sign abnormalities | Baseline through 12 months after the last dose (up to approximately 20 months). | Number of participants with clinically significant vital sign abnormalities, as assessed by the investigator, in Parts 1 and 2. |
| Primary | Number of participants with clinically significant electrocardiogram abnormalities | Baseline through 12 months after the last dose (up to approximately 20 months). | Number of participants with clinically significant abnormalities on 12-lead electrocardiograms, as assessed by the investigator, in Parts 1 and 2. |
| Primary | Number of participants with clinically significant clinical laboratory abnormalities | Baseline through 12 months after the last dose (up to approximately 20 months). | Number of participants with clinically significant hematology, serum chemistry, coagulation or urinalysis abnormalities, as assessed by the investigator, in Parts 1 and 2. |
| Secondary | Maximum serum NOR-101 concentration (Cmax) | First dose through up to approximately 20 months after the last dose (up to approximately 28 months). | Maximum observed concentration in Part 1 and in Part 2. |
| Secondary | Area under the NOR-101 serum concentration-time curve (AUC) | First dose through up to approximately 20 months after the last dose (up to approximately 28 months). | AUC from dosing to the last quantifiable concentration after single dosing, and over the dosing interval after repeated dosing, in Part 1. AUC following multiple dosing in Part 2. |
| Secondary | NOR-101 terminal elimination half-life | First dose through up to approximately 20 months after the last dose (up to approximately 28 months). | Terminal half-life after single or repeated dosing in Part 1, where reliably estimable. |
| Secondary | Incidence of anti-NOR-101 antibodies | First dose through up to approximately 20 months after the last dose (up to approximately 28 months). | Participants with anti-drug antibodies in Parts 1 and 2. |
| Secondary | NOR-101 time to maximum serum concentration (Tmax) | First dose through up to approximately 20 months after the last dose (up to approximately 28 months). | Time to maximum observed serum concentration after single and repeated dosing in Part 1. |
| Secondary | NOR-101 apparent clearance (CL/F) | First dose through up to approximately 20 months after the last dose (up to approximately 28 months). | Apparent serum clearance after single and repeated dosing in Part 1, where reliably estimable. |
| Secondary | NOR-101 apparent volume of distribution (Vz/F) | First dose through up to approximately 20 months after the last dose (up to approximately 28 months). | Apparent volume of distribution during the terminal phase after single and repeated dosing in Part 1, where reliably estimable. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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