Trial · NCT07903064
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Participant incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) | Up to 24 weeks | Summary of TEAEs and SAEs |
| Primary | Clinically significant abnormalities in safety laboratory tests | Up to approximately 20 weeks | Number of participants with clinically significant abnormalities in protocol-specified clinical laboratory assessments, including hematology, coagulation, chemistry, and urinalysis. |
| Primary | Clinically significant changes in spirometry for the 900mg IV Cohort in Part 1 (FEV1) | Baseline through Day 92 (approximately 13 weeks) | Change from baseline in FEV1 measured by spirometry in participants in the highest planned dose cohort (900 mg IV). FEV1 is normalized using the standards specified in the protocol. |
| Primary | Clinically significant abnormalities in Vital Signs | Up to approximately 20 weeks | Number of participants with clinically significant abnormalities in protocol-specified vital sign assessments, including blood pressure, heart rate, respiratory rate, body temperature, and pulse oximetry. |
| Primary | Clinically Significant Abnormalities in 12-Lead ECG QTcF Interval | Up to approximately 20 weeks | Number of participants with clinically significant abnormalities in QT interval corrected for heart rate using Fridericia's formula (QTcF), as assessed by 12-lead ECG. |
| Primary | Clinically significant abnormalities on Physical Examination | Up to approximately 20 weeks | Number of participants with clinically significant abnormalities identified during protocol-specified physical examinations. Complete physical examinations include assessment of the head, eyes, ears, nose, and throat (HEENT); neck; chest; lungs; abdomen; musculoskeletal, neurological, dermatological, cardiovascular, and peripheral vascular systems; and any areas of note identified during the daily review of adverse events. Targeted physical examinations are symptom-directed. |
| Primary | Clinically significant changes in spirometry from Baseline in Forced Vital Capacity (FVC) in the 900 mg IV Cohort | Baseline through Day 92 (approximately 13 weeks) | Change from baseline in FVC measured by spirometry in participants in the highest planned dose cohort (900 mg IV). |
| Primary | Clinically significant changes in spirometry from Baseline in FEV1/FVC Ratio in the 900 mg IV Cohort | Baseline through Day 92 (approximately 13 weeks) | Change from baseline in the ratio of FEV1 to FVC measured by spirometry in participants in the highest planned dose cohort (900 mg IV). |
| Primary | Clinically significant changes in spirometry from Baseline in Forced Expiratory Flow at 25% to 75% of FVC (FEF25-75%) in the 900 mg IV Cohort | Baseline through Day 92 (approximately 13 weeks) | Change from baseline in FEF25-75% measured by spirometry in participants in the highest planned dose cohort (900 mg IV). |
| Secondary | Part 1 serum pharmacokinetic parameters (Cmax) of BLN-481 | Up to 13 weeks | Maximum observed serum concentration of BLN-481. |
| Secondary | Part 1 serum pharmacokinetic parameters (Tmax) of BLN-481 | Up to 13 weeks | Time of maximum observed serum concentration of BLN-481. |
| Secondary | Part 1 serum pharmacokinetic parameters [AUC(0-T)] of BLN-481 | Up to 13 weeks | Area under the serum concentration-time curve from time 0 to the time of the last quantifiable concentration. |
| Secondary | Part 1 serum pharmacokinetic parameters [AUC(INF)] of BLN-481 | Up to 13 weeks | Area under the serum concentration-time curve from time 0 extrapolated to infinite time. |
| Secondary | Part 1 serum pharmacokinetic parameters (T-HALF) of BLN-481 | Up to 13 weeks | Terminal elimination half-life of BLN-481. |
| Secondary | Part 1 serum pharmacokinetic parameters Total Body Clearance (CLT) of BLN-481 | Up to 13 Weeks | Total body clearance of BLN-481 following intravenous administration. |
| Secondary | Incidence of anti-drug antibodies (ADA) to BLN-481 | Up to approximately 20 weeks | Summary of ADA incidence by treatment arm and study part. |
| Secondary | Part 1 serum pharmacokinetic parameters T(CLT/F) of BLN-481 | Up to 13 weeks | Apparent total body clearance of BLN-481 following subcutaneous administration. |
| Secondary | Part 1 serum pharmacokinetic parameters (Vz) of BLN-481 | Up to 13 weeks | Volume of distribution of the terminal phase of BLN-481 following intravenous administration. |
| Secondary | Part 1 serum pharmacokinetic parameters (Vz/F) of BLN-481 | Up to 13 weeks | Apparent volume of distribution of the terminal phase of BLN-481 following subcutaneous administration. |
| Secondary | Part 1 serum pharmacokinetic parameters Absolute Bioavailability of BLN-481 Following Subcutaneous Administration | Up to 13 weeks | Absolute bioavailability of BLN-481 following a single subcutaneous administration. |
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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