Trial · NCT07883226
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events | Cohort 1: Day 1 through Day 19. Cohort 2 Arm A: Period 1, Day 1 through Day 8; Period 2, Day -4 through Day 16. Cohort 2 Arm B: Period 1, Day 1 through Day 8; Period 2, Day -10 through Day 8. Cohort 3: Day 1 through Day 92. | Number of participants with one or more treatment-emergent adverse events, summarized overall and by severity, Investigator-assessed relationship to trial intervention, System Organ Class, and Preferred Term. |
| Primary | Number of Participants With Serious Adverse Events | Cohort 1: Day 1 through Day 19. Cohort 2 Arm A: Period 1, Day 1 through Day 8; Period 2, Day -4 through Day 16. Cohort 2 Arm B: Period 1, Day 1 through Day 8; Period 2, Day -10 through Day 8. Cohort 3: Day 1 through Day 92. | Number of participants with one or more serious adverse events, summarized overall and by severity, Investigator-assessed relationship to trial intervention, System Organ Class, and Preferred Term. |
| Primary | Number of Participants With Adverse Events Leading to Trial Intervention Interruption | Cohort 1: Day 1 through Day 19. Cohort 2 Arm A: Period 1, Day 1 through Day 8; Period 2, Day -4 through Day 16. Cohort 2 Arm B: Period 1, Day 1 through Day 8; Period 2, Day -10 through Day 8. Cohort 3: Day 1 through Day 92. | Number of participants with one or more adverse events resulting in temporary interruption of trial intervention, summarized overall and by severity, Investigator-assessed relationship to trial intervention, System Organ Class, and Preferred Term. |
| Primary | Number of Participants With Adverse Events Leading to Trial Intervention Discontinuation | Cohort 1: Day 1 through Day 19. Cohort 2 Arm A: Period 1, Day 1 through Day 8; Period 2, Day -4 through Day 16. Cohort 2 Arm B: Period 1, Day 1 through Day 8; Period 2, Day -10 through Day 8. Cohort 3: Day 1 through Day 92. | Number of participants with one or more adverse events resulting in permanent discontinuation of trial intervention, summarized overall and by severity, Investigator-assessed relationship to trial intervention, System Organ Class, and Preferred Term. |
| Primary | Number of Participants With Treatment-Emergent Clinical Chemistry Abnormalities | Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92. | Number of participants with treatment-emergent clinical chemistry abnormalities, summarized by visit, worst post-baseline grade, and grade shift from baseline using the protocol-specified toxicity grading criteria. |
| Primary | Number of Participants With Treatment-Emergent Hematology Abnormalities | Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92. | Number of participants with treatment-emergent hematology abnormalities, summarized by visit, worst post-baseline grade, and grade shift from baseline using the protocol-specified toxicity grading criteria. |
| Primary | Number of Participants With Treatment-Emergent Coagulation Abnormalities | Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92. | Number of participants with treatment-emergent coagulation abnormalities, summarized by visit, worst post-baseline grade, and grade shift from baseline using the protocol-specified toxicity grading criteria. |
| Primary | Number of Participants With Treatment-Emergent Urinalysis Abnormalities | Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92. | Number of participants with treatment-emergent urinalysis abnormalities, summarized by visit, worst post-baseline grade, and grade shift from baseline using the protocol-specified toxicity grading criteria. |
| Primary | Number of Participants With Treatment-Emergent Lipid Profile Abnormalities | Baseline and scheduled post-baseline assessments from Day 1 through Day 92 for Cohort 3. | Number of Cohort 3 participants with treatment-emergent lipid profile abnormalities, summarized by visit, worst post-baseline grade, and grade shift from baseline. |
| Primary | Change From Baseline in Systolic Blood Pressure | Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92. | Change from baseline in systolic blood pressure, measured in millimeters of mercury (mmHg). |
| Primary | Change From Baseline in Diastolic Blood Pressure | Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92. | Change from baseline in diastolic blood pressure, measured in millimeters of mercury (mmHg) |
| Primary | Change From Baseline in Heart Rate | Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92. | Change from baseline in heart rate, measured in beats per minute (bpm) |
| Primary | Change From Baseline in Body Temperature | Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92. | Change from baseline in body temperature, measured in degrees Celsius (°C) |
| Primary | Change From Baseline in 12-Lead ECG Heart Rate | Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92. | Change From Baseline in 12-Lead ECG Heart Rate Change from baseline in 12-lead ECG heart rate, measured in beats per minute (bpm) |
| Primary | Change From Baseline in RR Interval | Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92. | Change From Baseline in RR Interval Change from baseline in RR interval, measured in milliseconds (ms). |
| Primary | Change From Baseline in PR Interval | Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92. | Change From Baseline in PR Interval Change from baseline in PR interval, measured in milliseconds (ms). |
| Primary | Change From Baseline in QRS Duration | Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92. | Change From Baseline in QRS Duration Change from baseline in QRS duration, measured in milliseconds (ms). |
| Primary | Change From Baseline in QT Interval | Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92. | Change From Baseline in QT Interval Change from baseline in QT interval, measured in milliseconds (ms). |
| Primary | Change From Baseline in QTcF Interval | Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92. | Change from baseline in QT interval corrected for heart rate using Fridericia's formula (QTcF), measured in milliseconds (ms). |
| Secondary | Maximum Observed Plasma Concentration of TBD11 | Cohort 1: Day 1 and Day 14. Cohort 3: Day 1 and Day 84. | Maximum observed plasma concentration (Cmax) of TBD11 following single-dose and multiple-dose administration, measured in nanograms per milliliter (ng/mL). |
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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