Healthy Volunteers (no Disease Condition Under Study)Phase 1NCT07903064
A Phase 1, First-in-Human Trial of BLN-481in Healthy Adult Participants
A Phase 1 study testing BLN-481 in people with Healthy Volunteers (no Disease Condition Under Study), run by Beeline Medicines Corporation.
Trial summary
This Phase 1 first-in-human study will evaluate BLN-481 in healthy adults. Participants will receive BLN-481 or placebo. Part 1 evaluates single ascending intravenous (IV) doses (SAD) and optional subcutaneous (SC) doses. Part 2 evaluates multiple ascending subcutaneous doses (MAD). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers (no Disease Condition Under Study)
- What is being tested?
- BLN-481
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- 12 Oct 2026to 24 Nov 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ability to provide informed consent
- Healthy adults 18-55 years, inclusive
- Body mass index (BMI) between 18 and 32 kg/m2 inclusive at screening
- Willing and able to comply with visits, restrictions, laboratory tests, contraception requirements, and study procedure
- Meets protocol-defined reproductive and contraception requirements
Who cannot join
- Inability to comply with trial protocol and lifestyle restrictions
- Clinically significant medical history, examination, vital-sign, ECG, laboratory, or spirometry findings.
- Active or relevant infection, including protocol-defined HBV, HCV, HIV, tuberculosis, or Treponema pallidum findings.
- Significant allergy, drug reaction, treated asthma/reactive airway disease, hypercoagulation, thrombotic disease, or recent substance abuse.
- Pregnancy, breastfeeding, or planned pregnancy/breastfeeding during the study.
- Prohibited recent medication, live vaccine, surgery (planned or within 12 weeks of Day -1), blood donation/transfusion, tobacco/nicotine use, or inability to comply with study restrictions.
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- Participation in another investigational study or other protocol-defined exclusion.
- The participant has a percent predicted forced expiratory volume in the first second that doesn't meet study requirements
- Prisoners or participants who are incarcerated
- Donated blood within 30 days of check-in
- Blood transfusion within 8 weeks of check-in
- Inability to be venipunctured and/or tolerate venous access
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1, Randomized, Multi-Part, First-in-Human Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of BLN-481 in Healthy Adult Participants
This Phase 1 first-in-human study will evaluate BLN-481 in healthy adults. Participants will receive BLN-481 or placebo. Part 1 evaluates single ascending intravenous (IV) doses (SAD) and optional subcutaneous (SC) doses. Part 2 evaluates multiple ascending subcutaneous doses (MAD). The main purpose is to assess safety and tolerability. The study will also evaluate how BLN-481 moves through the body, whether anti-drug antibodies (ANA) develop, and pharmacodynamic (PD) effects.
Read the detailed description
BLN-481 is a monoclonal allosteric blocking antibody targeting IL-18 receptor beta (IL-18Rβ). The study is randomized, double-blind, placebo-controlled, and uses sentinel dosing in each cohort. Part 1 includes sequential single-dose cohorts; Part 2 includes sequential multiple-dose cohorts administered every 2 (Q2W) or 4 (Q4W) weeks for three total doses. Dose escalation decisions will be based on review of available safety, tolerability, and pharmacokinetic (PK) data by the Dose Escalation Committee. Approximately 104 healthy adult participants are planned.
- Being tested
- Placebo, BLN-481
- Keywords
- IL-18Rβ, BLN-481, Healthy volunteers, First-in-human, Single Ascending Dose, Multiple Ascending Dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Placebo for BLN-481
Matching placebo is administered by the same route and on the same schedule as the assigned BLN-481 cohort. Part 1 placebo is administered as a single IV infusion or SC injection. Part 2 placebo is administered SC Q2W or Q4W for 3 total doses. Each cohort uses blinded sentinel dosing: 1 participant assigned to BLN-481 and 1 participant assigned to placebo are dosed first before the remaining cohort participants.
BLN-481Drug
Part 1 (SAD): Single IV doses in Cohorts 1A-1E at planned doses of 10, 30, 100, 300, and 900 mg. Optional Cohort 1X may receive a single IV or SC dose; optional Cohorts 1Y and 1Z may receive a single SC dose, with dose levels to be determined. Each Part 1 cohort includes up to 8 participants randomized 6:2 to BLN-481: placebo. Part 2 (MAD): SC dosing in Cohort 2A at 50 mg Q2W, Cohort 2B at 150 mg Q2W, and Cohort 2C at 450 mg Q2W or Q4W, for 3 total doses. Optional Cohort 2D may receive a dose to be determined Q2W or Q4W for 3 total doses. Each Part 2 cohort includes up to 10 participants randomized 8:2 to BLN-481: placebo.
| Study group | Role | What they receive |
|---|---|---|
| BLN-481 | Experimental | Part 1 (SAD): Single IV doses in Cohorts 1A-1E at planned doses of 10, 30, 100, 300, and 900 mg. Optional Cohort 1X may receive a single IV or SC dose; optional Cohorts 1Y and 1Z may receive a single SC dose, with dose levels to be determined. Each Part 1 cohort includes up to 8 participants randomized 6:2 to BLN-481: placebo. Part 2 (MAD): SC dosing in Cohort 2A at 50 mg Q2W, Cohort 2B at 150 mg Q2W, and Cohort 2C at 450 mg Q2W or Q4W, for 3 total doses. Optional Cohort 2D may receive a dose to be determined Q2W or Q4W for 3 total doses. Each Part 2 cohort includes up to 10 participants randomized 8:2 to BLN-481: placebo. Receives: Drug: BLN-481 |
| Placebo | Placebo comparator | Matching placebo is administered by the same route and on the same schedule as the assigned BLN-481 cohort. Part 1 placebo is administered as a single IV infusion or SC injection. Part 2 placebo is administered SC Q2W or Q4W for 3 total doses. Each cohort uses blinded sentinel dosing: 1 participant assigned to BLN-481 and 1 participant assigned to placebo are dosed first before the remaining cohort participants. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Summary of TEAEs and SAEs
Measured: Up to 24 weeks
Clinically significant abnormalities in safety laboratory tests
Number of participants with clinically significant abnormalities in protocol-specified clinical laboratory assessments, including hematology, coagulation, chemistry, and urinalysis.
Measured: Up to approximately 20 weeks
Clinically significant changes in spirometry for the 900mg IV Cohort in Part 1 (FEV1)
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.
Measured: Baseline through Day 92 (approximately 13 weeks)
Clinically significant abnormalities in Vital Signs
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.
Measured: Up to approximately 20 weeks
Clinically Significant Abnormalities in 12-Lead ECG QTcF Interval
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.
Measured: Up to approximately 20 weeks
Clinically significant abnormalities on Physical Examination
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.
Measured: Up to approximately 20 weeks
Clinically significant changes in spirometry from Baseline in Forced Vital Capacity (FVC) in the 900 mg IV Cohort
Change from baseline in FVC measured by spirometry in participants in the highest planned dose cohort (900 mg IV).
Measured: Baseline through Day 92 (approximately 13 weeks)
Clinically significant changes in spirometry from Baseline in FEV1/FVC Ratio in the 900 mg IV Cohort
Change from baseline in the ratio of FEV1 to FVC measured by spirometry in participants in the highest planned dose cohort (900 mg IV).
Measured: Baseline through Day 92 (approximately 13 weeks)
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
Change from baseline in FEF25-75% measured by spirometry in participants in the highest planned dose cohort (900 mg IV).
Measured: Baseline through Day 92 (approximately 13 weeks)
Secondary outcomes (18)
Part 1 serum pharmacokinetic parameters (Cmax) of BLN-481
Maximum observed serum concentration of BLN-481.
Measured: Up to 13 weeks
Part 1 serum pharmacokinetic parameters (Tmax) of BLN-481
Time of maximum observed serum concentration of BLN-481.
Measured: Up to 13 weeks
Part 1 serum pharmacokinetic parameters [AUC(0-T)] of BLN-481
Area under the serum concentration-time curve from time 0 to the time of the last quantifiable concentration.
Measured: Up to 13 weeks
Part 1 serum pharmacokinetic parameters [AUC(INF)] of BLN-481
Area under the serum concentration-time curve from time 0 extrapolated to infinite time.
Measured: Up to 13 weeks
Part 1 serum pharmacokinetic parameters (T-HALF) of BLN-481
Terminal elimination half-life of BLN-481.
Measured: Up to 13 weeks
Part 1 serum pharmacokinetic parameters Total Body Clearance (CLT) of BLN-481
Total body clearance of BLN-481 following intravenous administration.
Measured: Up to 13 Weeks
Incidence of anti-drug antibodies (ADA) to BLN-481
Summary of ADA incidence by treatment arm and study part.
Measured: Up to approximately 20 weeks
Part 1 serum pharmacokinetic parameters T(CLT/F) of BLN-481
Apparent total body clearance of BLN-481 following subcutaneous administration.
Measured: Up to 13 weeks
Part 1 serum pharmacokinetic parameters (Vz) of BLN-481
Volume of distribution of the terminal phase of BLN-481 following intravenous administration.
Measured: Up to 13 weeks
Part 1 serum pharmacokinetic parameters (Vz/F) of BLN-481
Apparent volume of distribution of the terminal phase of BLN-481 following subcutaneous administration.
Measured: Up to 13 weeks
Part 1 serum pharmacokinetic parameters Absolute Bioavailability of BLN-481 Following Subcutaneous Administration
Absolute bioavailability of BLN-481 following a single subcutaneous administration.
Measured: Up to 13 weeks
Part 2 serum pharmacokinetic parameters (Cmax) of BLN-481
Time of maximum observed serum concentration of BLN-481.
Measured: Up to 20 weeks
Part 2 serum pharmacokinetic parameters (Tmax) of BLN-481
Time of maximum observed serum concentration of BLN-481.
Measured: Up to 20 weeks
Part 2 serum pharmacokinetic parameters [AUC(TAU)] of BLN-481
Area under the serum concentration-time curve within a dosing interval.
Measured: Up to 20 weeks
Part 2 serum pharmacokinetic parameters (Ctrough) of BLN-481
Trough observed serum concentration of BLN-481.
Measured: Up to 20 weeks
Part 2 serum pharmacokinetic parameters (T-HALF) of BLN-481
Terminal elimination half-life of BLN-481.
Measured: Up to 20 weeks
Part 2 serum pharmacokinetic parameters (AI_AUC) of BLN-481
Ratio of AUC(TAU) after the third dose to AUC(TAU) after the first dose.
Measured: Up to 20 weeks
Part 2 serum pharmacokinetic parameters (AI_Cmax) of BLN-481
Ratio of Cmax after the third dose to Cmax after the first dose.
Measured: Up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start12 Oct 2026 (estimated)
- Primary completion24 Nov 2027 (estimated)
- Study completion24 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers (no Disease Condition Under Study)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beeline Medicines Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nucleus Network Ltd
- Responsible party
- Sponsor
- Investigators
- Jerome Hanna, Study director, Beeline Medicines Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07903064
- Sponsor's protocol ID
- 481-FIH-101
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participate data will not be shared as this phase 1 study is explicitly designed to evaluate the safety, tolerability, and initial pharmacokinetics. The Sponsor intends to report study results in aggregate form, as applicable.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Multi-Part, First-in-Human Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of BLN-481 in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07903064
- Acronym / sponsor ID
- 481-FIH-101
- Keywords
- IL-18Rβ, BLN-481, Healthy volunteers, First-in-human, Single Ascending Dose, Multiple Ascending Dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Beeline Medicines CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Nucleus Network Ltd
- Study start
- 12 Oct 2026 (estimated)
- Primary completion
- 24 Nov 2027 (estimated)
- Study completion
- 24 Nov 2027 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 1 first-in-human study will evaluate BLN-481 in healthy adults. Participants will receive BLN-481 or placebo. Part 1 evaluates single ascending intravenous (IV) doses (SAD) and optional subcutaneous (SC) doses. Part 2 evaluates multiple ascending subcutaneous doses (MAD). The main purpose is to assess safety and tolerability. The study will also evaluate how BLN-481 moves through the body, whether anti-drug antibodies (ANA) develop, and pharmacodynamic (PD) effects.
Detailed description
BLN-481 is a monoclonal allosteric blocking antibody targeting IL-18 receptor beta (IL-18Rβ). The study is randomized, double-blind, placebo-controlled, and uses sentinel dosing in each cohort. Part 1 includes sequential single-dose cohorts; Part 2 includes sequential multiple-dose cohorts administered every 2 (Q2W) or 4 (Q4W) weeks for three total doses. Dose escalation decisions will be based on review of available safety, tolerability, and pharmacokinetic (PK) data by the Dose Escalation Committee. Approximately 104 healthy adult participants are planned.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BLN-481 | Experimental | Drug: BLN-481Part 1 (SAD): Single IV doses in Cohorts 1A-1E at planned doses of 10, 30, 100, 300, and 900 mg. Optional Cohort 1X may receive a single IV or SC dose; optional Cohorts 1Y and 1Z may receive a single SC dose, with dose levels to be determined. Each Part 1 cohort includes up to 8 participants randomized 6:2 to BLN-481: placebo. Part 2 (MAD): SC dosing in Cohort 2A at 50 mg Q2W, Cohort 2B at 150 mg Q2W, and Cohort 2C at 450 mg Q2W or Q4W, for 3 total doses. Optional Cohort 2D may receive a dose to be determined Q2W or Q4W for 3 total doses. Each Part 2 cohort includes up to 10 participants randomized 8:2 to BLN-481: placebo. |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo is administered by the same route and on the same schedule as the assigned BLN-481 cohort. Part 1 placebo is administered as a single IV infusion or SC injection. Part 2 placebo is administered SC Q2W or Q4W for 3 total doses. Each cohort uses blinded sentinel dosing: 1 participant assigned to BLN-481 and 1 participant assigned to placebo are dosed first before the remaining cohort participants. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Ability to provide informed consent
- Healthy adults 18-55 years, inclusive
- Body mass index (BMI) between 18 and 32 kg/m2 inclusive at screening
- Willing and able to comply with visits, restrictions, laboratory tests, contraception requirements, and study procedure
- Meets protocol-defined reproductive and contraception requirements
Key exclusion criteria (12 listed)
- Inability to comply with trial protocol and lifestyle restrictions
- Clinically significant medical history, examination, vital-sign, ECG, laboratory, or spirometry findings.
- Active or relevant infection, including protocol-defined HBV, HCV, HIV, tuberculosis, or Treponema pallidum findings.
- Significant allergy, drug reaction, treated asthma/reactive airway disease, hypercoagulation, thrombotic disease, or recent substance abuse.
- Pregnancy, breastfeeding, or planned pregnancy/breastfeeding during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: Placebo for BLN-481Matching placebo is administered by the same route and on the same schedule as the assigned BLN-481 cohort. Part 1 placebo is administered as a single IV infusion or SC injection. Part 2 placebo is administered SC Q2W or Q4W for 3 total doses. Each cohort uses blinded sentinel dosing: 1 participant assigned to BLN-481 and 1 participant assigned to placebo are dosed first before the remaining cohort participants. | Drug | Placebo |
| BLN-481Part 1 (SAD): Single IV doses in Cohorts 1A-1E at planned doses of 10, 30, 100, 300, and 900 mg. Optional Cohort 1X may receive a single IV or SC dose; optional Cohorts 1Y and 1Z may receive a single SC dose, with dose levels to be determined. Each Part 1 cohort includes up to 8 participants randomized 6:2 to BLN-481: placebo. Part 2 (MAD): SC dosing in Cohort 2A at 50 mg Q2W, Cohort 2B at 150 mg Q2W, and Cohort 2C at 450 mg Q2W or Q4W, for 3 total doses. Optional Cohort 2D may receive a dose to be determined Q2W or Q4W for 3 total doses. Each Part 2 cohort includes up to 10 participants randomized 8:2 to BLN-481: placebo. | Drug | BLN-481 |
Primary outcome
Participant incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time frame: Up to 24 weeks
Summary of TEAEs and SAEs
Clinically significant abnormalities in safety laboratory tests
Time frame: Up to approximately 20 weeks
Number of participants with clinically significant abnormalities in protocol-specified clinical laboratory assessments, including hematology, coagulation, chemistry, and urinalysis.
Clinically significant changes in spirometry for the 900mg IV Cohort in Part 1 (FEV1)
Time frame: 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.
Clinically significant abnormalities in Vital Signs
Time frame: 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.
Clinically Significant Abnormalities in 12-Lead ECG QTcF Interval
Time frame: 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.
Clinically significant abnormalities on Physical Examination
Time frame: 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.
Clinically significant changes in spirometry from Baseline in Forced Vital Capacity (FVC) in the 900 mg IV Cohort
Time frame: 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).
Clinically significant changes in spirometry from Baseline in FEV1/FVC Ratio in the 900 mg IV Cohort
Time frame: 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).
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
Time frame: 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).
18 secondary outcomes
Part 1 serum pharmacokinetic parameters (Cmax) of BLN-481
Time frame: Up to 13 weeks
Part 1 serum pharmacokinetic parameters (Tmax) of BLN-481
Time frame: Up to 13 weeks
Part 1 serum pharmacokinetic parameters [AUC(0-T)] of BLN-481
Time frame: Up to 13 weeks
Part 1 serum pharmacokinetic parameters [AUC(INF)] of BLN-481
Time frame: Up to 13 weeks
Part 1 serum pharmacokinetic parameters (T-HALF) of BLN-481
Time frame: Up to 13 weeks
Part 1 serum pharmacokinetic parameters Total Body Clearance (CLT) of BLN-481
Time frame: Up to 13 Weeks
Incidence of anti-drug antibodies (ADA) to BLN-481
Time frame: Up to approximately 20 weeks
Part 1 serum pharmacokinetic parameters T(CLT/F) of BLN-481
Time frame: Up to 13 weeks
Part 1 serum pharmacokinetic parameters (Vz) of BLN-481
Time frame: Up to 13 weeks
Part 1 serum pharmacokinetic parameters (Vz/F) of BLN-481
Time frame: Up to 13 weeks
Part 1 serum pharmacokinetic parameters Absolute Bioavailability of BLN-481 Following Subcutaneous Administration
Time frame: Up to 13 weeks
Part 2 serum pharmacokinetic parameters (Cmax) of BLN-481
Time frame: Up to 20 weeks
Part 2 serum pharmacokinetic parameters (Tmax) of BLN-481
Time frame: Up to 20 weeks
Part 2 serum pharmacokinetic parameters [AUC(TAU)] of BLN-481
Time frame: Up to 20 weeks
Part 2 serum pharmacokinetic parameters (Ctrough) of BLN-481
Time frame: Up to 20 weeks
Part 2 serum pharmacokinetic parameters (T-HALF) of BLN-481
Time frame: Up to 20 weeks
Part 2 serum pharmacokinetic parameters (AI_AUC) of BLN-481
Time frame: Up to 20 weeks
Part 2 serum pharmacokinetic parameters (AI_Cmax) of BLN-481
Time frame: Up to 20 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No. Individual participate data will not be shared as this phase 1 study is explicitly designed to evaluate the safety, tolerability, and initial pharmacokinetics. The Sponsor intends to report study results in aggregate form, as applicable.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jerome Hanna study director
Beeline Medicines Corporation
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BLN-481 in people with Healthy Volunteers (no Disease Condition Under Study), run by Beeline Medicines Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Director (+1-617-885-8290, medinfo@beelinemedicines.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) (time frame: Up to 24 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.