Trial · NCT07903064
A Phase 1, First-in-Human Trial of BLN-481in Healthy Adult Participants
NCT07903064, Phase 1, Recruiting, Beeline Medicines Corporation
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 1, First-in-Human Trial of BLN-481in Healthy Adult Participants. Trials, record NCT07903064. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07903064
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 1, First-in-Human Trial of BLN-481in Healthy Adult Participants
- NCT number
- NCT07903064
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 104 participants, estimated
- Lead sponsor
- Beeline Medicines Corporation
- Conditions
- Healthy Volunteers (no Disease Condition Under Study)
- Interventions
- Placebo, BLN-481
- First posted
- 2026-10-29
- Last updated
- 2026-11-12
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07903064
GET https://conductscience.org/api/trials/v1/NCT07903064/registered?page=2