Trial · NCT07906665
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With incidence and severity of treatment-emergent adverse events | Day 1 through Day 28 | Number and percentage of participants with treatment-emergent adverse events, graded by severity according to NCI CTCAE version 5.0. |
| Primary | Number of Participants With incidence and severity of treatment-emergent serious adverse events | Day 1 through Day 28 | Number and percentage of participants with treatment-emergent serious adverse events, graded by severity according to NCI CTCAE version 5.0. |
| Primary | Number of Participants With Treatment-Emergent Clinically Significant Blood Pressure Abnormalities | Day 1 through Day 28 | Systolic and diastolic blood pressure, in mmHg, measured at screening, predose on Day 1, within one hour before the 2-hour and 4-hour postdose pharmacokinetic blood draws on Day 1, at 24 hours postdose on Day 2, on Day 8 and on Day 28. A value or finding is counted as clinically significant where it is newly present after dosing and the Investigator records it as clinically significant, applying the protocol definition: a finding that meets serious adverse event criteria, necessitates specific corrective therapy, or is deemed clinically significant by the Investigator. The single reported value is the NUMBER OF PARTICIPANTS with at least one such finding, by treatment arm. |
| Primary | Number of Participants With Treatment-Emergent Clinically Significant Pulse Rate Abnormalities | Day 1 through Day 28 | Pulse rate, in beats per minute, measured at screening, predose on Day 1, within one hour before the 2-hour and 4-hour postdose pharmacokinetic blood draws on Day 1, at 24 hours postdose on Day 2, on Day 8 and on Day 28. A value or finding is counted as clinically significant where it is newly present after dosing and the Investigator records it as clinically significant, applying the protocol definition: a finding that meets serious adverse event criteria, necessitates specific corrective therapy, or is deemed clinically significant by the Investigator. The single reported value is the NUMBER OF PARTICIPANTS with at least one such finding, by treatment arm. |
| Primary | Number of Participants With Treatment-Emergent Clinically Significant Respiratory Rate Abnormalities | Day 1 through Day 28 | Respiratory rate, in breaths per minute, measured at screening, predose on Day 1, within one hour before the 2-hour and 4-hour postdose pharmacokinetic blood draws on Day 1, at 24 hours postdose on Day 2, on Day 8 and on Day 28. A value or finding is counted as clinically significant where it is newly present after dosing and the Investigator records it as clinically significant, applying the protocol definition: a finding that meets serious adverse event criteria, necessitates specific corrective therapy, or is deemed clinically significant by the Investigator. The single reported value is the NUMBER OF PARTICIPANTS with at least one such finding, by treatment arm. |
| Primary | Number of Participants With Treatment-Emergent Clinically Significant Body Temperature Abnormalities | Day 1 through Day 28 | Body temperature, in °C, measured at screening, predose on Day 1, within one hour before the 2-hour and 4-hour postdose pharmacokinetic blood draws on Day 1, at 24 hours postdose on Day 2, on Day 8 and on Day 28. A value or finding is counted as clinically significant where it is newly present after dosing and the Investigator records it as clinically significant, applying the protocol definition: a finding that meets serious adverse event criteria, necessitates specific corrective therapy, or is deemed clinically significant by the Investigator. The single reported value is the NUMBER OF PARTICIPANTS with at least one such finding, by treatment arm. |
| Primary | Number of Participants With Treatment-Emergent Clinically Significant Neurological Examination Findings | Day 1 through Day 8 | A neurological examination is performed at screening, predose on Day 1, at 3 hours and 6 hours postdose on Day 1, at 24 hours postdose on Day 2, and on Day 8. A value or finding is counted as clinically significant where it is newly present after dosing and the Investigator records it as clinically significant, applying the protocol definition: a finding that meets serious adverse event criteria, necessitates specific corrective therapy, or is deemed clinically significant by the Investigator. The single reported value is the NUMBER OF PARTICIPANTS with at least one such finding, by treatment arm. |
| Primary | Number of Participants With Treatment-Emergent Clinically Significant Physical Examination Findings | Day 1 through Day 8 | A physical examination is performed at screening and predose on Day 1. A limited physical examination is performed at 24 hours postdose on Day 2 and on Day 8, at the Investigator's discretion. A value or finding is counted as clinically significant where it is newly present after dosing and the Investigator records it as clinically significant, applying the protocol definition: a finding that meets serious adverse event criteria, necessitates specific corrective therapy, or is deemed clinically significant by the Investigator. The single reported value is the NUMBER OF PARTICIPANTS with at least one such finding, by treatment arm. |
| Primary | Number of Participants With Treatment-Emergent Clinically Significant 12-Lead Electrocardiogram Abnormalities, Including QT Interval Corrected by Fridericia's Formula (QTcF) | Day 1 through Day 28 | Triplicate 12-lead electrocardiograms are recorded after the participant has rested supine for at least 10 minutes, at screening, predose on Day 1, within one hour before the 2-hour and 4-hour postdose pharmacokinetic blood draws on Day 1, at 24 hours postdose on Day 2, on Day 8 and on Day 28. The first recording is interpreted and the remaining two are checked for consistency and quality. The QT interval is corrected by Fridericia's formula and reported in milliseconds. A QTcF above 500 ms, or an increase from baseline above 60 ms, meets a protocol-defined dose-limiting toxicity criterion. A value or finding is counted as clinically significant where it is newly present after dosing and the Investigator records it as clinically significant, applying the protocol definition: a finding that meets serious adverse event criteria, necessitates specific corrective therapy, or is deemed clinically significant by the Investigator. The single reported value is the NUMBER OF PARTICIPANTS wit |
| Primary | Number of Participants With Treatment-Emergent Clinically Significant Hematology Abnormalities | Day 1 through Day 28 | Hematology comprises a complete blood count with differential, platelet count and absolute neutrophil count, collected at screening, predose on Day 1, at 24 hours postdose on Day 2, on Day 8 and on Day 28, and analyzed by a designated central laboratory. Coagulation testing (platelet count, international normalized ratio, prothrombin time and activated partial thromboplastin time) is performed at screening only. A laboratory value is counted as clinically significant where, per the protocol, it meets serious adverse event criteria, necessitates specific corrective therapy, or is deemed clinically significant by the Investigator. The single reported value is the number of participants with at least one such value, by treatment arm. |
| Primary | Number of Participants With Treatment-Emergent Clinically Significant Serum Chemistry Abnormalities | Day 1 through Day 28 | Serum chemistry comprises electrolytes, total protein, albumin, creatinine, blood urea nitrogen, uric acid, total and direct bilirubin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase, glucose, calcium, phosphorus, bicarbonate, chloride, sodium and potassium, collected at screening, predose on Day 1, at 24 hours postdose on Day 2, on Day 8 and on Day 28, and analyzed by a designated central laboratory. A laboratory value is counted as clinically significant where, per the protocol, it meets serious adverse event criteria, necessitates specific corrective therapy, or is deemed clinically significant by the Investigator. The single reported value is the number of participants with at least one such value, by treatment arm. |
| Primary | Number of Participants With Treatment-Emergent Clinically Significant Urinalysis Abnormalities | Day 1 through Day 28 | Urinalysis is performed by dipstick testing for blood, protein and glucose, with microscopic examination where an abnormality is detected, at screening, predose on Day 1, at 24 hours postdose on Day 2, on Day 8 and on Day 28, analyzed by a designated central laboratory. A finding is counted as clinically significant where, per the protocol, it meets serious adverse event criteria, necessitates specific corrective therapy, or is deemed clinically significant by the Investigator. The single reported value is the number of participants with at least one such finding, by treatment arm. |
| Primary | Number of Participants With discontinuations due to adverse events | Day 1 through Day 28 | Number and percentage of participants discontinuing study intervention or withdrawing from the study because of an adverse event. |
| Primary | Maximum tolerated dose of single-dose NI112 | From the first dose of the first cohort through the Day 28 visit of the last subject in the highest cohort evaluated, approximately 13 months | The maximum tolerated dose identified by the Safety Review Board applying the pre-specified dose-escalation and stopping criteria together with clinical judgment. |
| Secondary | Peak Plasma Concentration (Cmax) of NI112 | Predose and 1, 2, 4, 6 and 24 hours postdose, and on Day 8 and Day 28 | NI112 concentration in plasma is measured by a validated analytical assay in samples collected predose on Day 1, at 1, 2, 4 and 6 hours postdose on Day 1, at 24 hours postdose on Day 2, on Day 8 and on Day 28. Cmax is the maximum observed plasma concentration, reported as a geometric mean with geometric coefficient of variation by dose cohort. |
| Secondary | Time to Peak Plasma Concentration (Tmax) of NI112 | Predose and 1, 2, 4, 6 and 24 hours postdose, and on Day 8 and Day 28 | NI112 concentration in plasma is measured by a validated analytical assay in samples collected predose on Day 1, at 1, 2, 4 and 6 hours postdose on Day 1, at 24 hours postdose on Day 2, on Day 8 and on Day 28. Tmax is the time at which the maximum observed plasma concentration occurs, reported as a median with range by dose cohort. |
| Secondary | Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC0-last) of NI112 | Predose and 1, 2, 4, 6 and 24 hours postdose, and on Day 8 and Day 28 | NI112 concentration in plasma is measured by a validated analytical assay in samples collected predose on Day 1, at 1, 2, 4 and 6 hours postdose on Day 1, at 24 hours postdose on Day 2, on Day 8 and on Day 28. AUC0-last is calculated by the trapezoidal method to the last measurable concentration, reported as a geometric mean with geometric coefficient of variation by dose cohort. |
| Secondary | Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of NI112 | Predose and 1, 2, 4, 6 and 24 hours postdose, and on Day 8 and Day 28 | NI112 concentration in plasma is measured by a validated analytical assay in samples collected predose on Day 1, at 1, 2, 4 and 6 hours postdose on Day 1, at 24 hours postdose on Day 2, on Day 8 and on Day 28. AUC0-inf is AUC0-last plus the extrapolated terminal area, reported as a geometric mean with geometric coefficient of variation by dose cohort, and is calculated where the terminal phase is adequately characterized. |
| Secondary | Apparent Terminal Elimination Half-Life (t1/2) of NI112 in Plasma | Predose and 1, 2, 4, 6 and 24 hours postdose, and on Day 8 and Day 28 | NI112 concentration in plasma is measured by a validated analytical assay in samples collected predose on Day 1, at 1, 2, 4 and 6 hours postdose on Day 1, at 24 hours postdose on Day 2, on Day 8 and on Day 28. t1/2 is the natural logarithm of 2 divided by the terminal elimination rate constant, reported as a geometric mean with geometric coefficient of variation by dose cohort. |
| Secondary | Cerebrospinal fluid concentration of NI112 | Day 1 predose and Day 2, 24 hours postdose | Cerebrospinal fluid is collected by lumbar puncture predose on Day 1 and 24 hours postdose on Day 2, and NI112 concentration is measured by a validated analytical assay. The concentration is reported as a geometric mean with geometric coefficient of variation by dose cohort. |
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.
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