Healthy VolunteerPhase 1NCT07662148
A Study to Learn More About the Safety of a Single Dose of BIIB144 and How it is Processed in the Body of Healthy Adult Participants Ages 18 to 55 Years Old as Compared to a Placebo
A Phase 1 study testing BIIB144 in people with Healthy Volunteer, run by Biogen at 1 site in United States.
Trial summary
In this study, researchers will learn how the body processes a study drug called BIIB144. This is a "first-in-human" study. This means that this study drug will be given to people for the first very time in this study. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- BIIB144
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2026to 19 Jun 2028
- 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
- Have a body mass index (BMI) between 18 and 32 kilograms per square metre (kg/m^2), inclusive, at Screening.
- Must be in good health as determined by the Investigator, based on medical history and Screening evaluations.
Who cannot join
- History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
- History of severe allergic or anaphylactic reactions, or of any allergic reactions that in the opinion of the Investigator are likely to be exacerbated by any component of the study treatment.
- History of, or ongoing, malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell carcinomas and squamous cell carcinomas that have been completely excised and considered cured at least 1 year prior to Day -1).
- History of, or positive test result at Screening for, human immunodeficiency virus (HIV).
- Any live or attenuated immunization or vaccination given within 14 days prior to Screening, between Screening and Day -1, or planned to be given during the study period.
- Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Global Biogen Clinical Trial Center contact
United States1 site, 1 recruiting
- Recruiting
Las Vegas Clinical Research Unit, PPD Development, LP
Las Vegas, Nevada, 89113
702-963-1600
Aishwarya Vyas Lahar
About this study
Official title: A Phase 1, Randomized, Blinded, Placebo-Controlled, Single Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB144 in Healthy Adult Participants
In this study, researchers will learn how the body processes a study drug called BIIB144. This is a "first-in-human" study. This means that this study drug will be given to people for the first very time in this study. These studies are important because they help researchers learn about the safety of the study drug, how the body processes it, and what dose might be appropriate before testing it in larger groups.
The main goal of this study is to learn more about the safety of a single dose of BIIB144 compared to a placebo. A placebo is something that looks like the study drug but does not contain any medicine. A placebo is also given in the same way as the study drug.
Read more
The main question researchers want to answer in this study is:
How many participants have adverse events (AEs) and serious adverse events (SAEs)? An AE is a health problem that may or may not be caused by the study drug.
Researchers will also learn more about:
- How the body processes BIIB144 compared to placebo.
This study will be done as follows:
- Participants will be screened to check if they can join the study. The screening period will be up to 28 days, after which eligible participants will check into their study research center.
- Participants will stay at their study research center for about 8 days. Afterwards, they will have up to 13 visits to their study research center.
- This will be a "dose escalation" study. In this kind of study, increasing amounts of study drug are given to different groups of participants. Usually, this is done until researchers find the highest dose that does not cause harmful effects. In this study, the number of dose groups and maximum dose are planned in advance. The dose escalation will stop once these planned groups are done or if safety concerns arise.
- There will be a total of 6 groups. In each group, participants will receive a single dose of either BIIB144 or the placebo through an intravenous (IV) needle.
- Throughout the study, participants will give blood and urine samples. Participants will also have physical exams and answer questions about how they are feeling.
- Each participant will be in the study for up to 44 weeks.
Read the detailed description
The primary objective of this study is to evaluate the safety and tolerability of IV administered ascending single doses of BIIB144 compared with placebo in healthy adult participants. The secondary objective is to characterize the pharmacokinetics (PK) of IV administered ascending single doses of BIIB144 in healthy adult participants.
- Conditions
- Healthy Volunteer
- Being tested
- BIIB144, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB144Drug
Administered IV
PlaceboDrug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| BIIB144 Cohort 1 | Experimental | Participants will receive Dose A of BIIB144 or a matching placebo via intravenous (IV) infusion on Day 1. Receives: Drug: BIIB144; Drug: Placebo |
| BIIB144 Cohort 2 | Experimental | Participants will receive Dose B of BIIB144 or a matching placebo via IV infusion on Day 1. Receives: Drug: BIIB144; Drug: Placebo |
| BIIB144 Cohort 3 | Experimental | Participants will receive Dose C of BIIB144 or a matching placebo via IV infusion on Day 1. Receives: Drug: BIIB144; Drug: Placebo |
| BIIB144 Cohort 4 | Experimental | Participants will receive Dose D of BIIB144 or a matching placebo via IV infusion on Day 1. Receives: Drug: BIIB144; Drug: Placebo |
| BIIB144 Cohort 5 | Experimental | Participants will receive Dose E of BIIB144 or a matching placebo via IV infusion on Day 1. Receives: Drug: BIIB144; Drug: Placebo |
| BIIB144 Cohort 6 | Experimental | Participants will receive Dose F of BIIB144 or a matching placebo via IV infusion on Day 1. Receives: Drug: BIIB144; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured: Up to Day 280
Secondary outcomes (7)
Area Under the Serum Concentration-Time Curve From Time Zero to Time of the Last Measurable Concentration (AUC0-last) of BIIB144
Measured: Pre-dose and at multiple time points post-dose up to Day 280
Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of BIIB144
Measured: Pre-dose and at multiple time points post-dose up to Day 280
Maximum Observed Serum Concentration (Cmax) of BIIB144
Measured: Pre-dose and at multiple time points post-dose up to Day 280
Time to Maximum Observed Serum Concentration (Tmax) of BIIB144
Measured: Pre-dose and at multiple time points post-dose up to Day 280
Terminal Elimination Half-Life (t½) of BIIB144
Measured: Pre-dose and at multiple time points post-dose up to Day 280
Total Body Clearance (CL) of BIIB144
Measured: Pre-dose and at multiple time points post-dose up to Day 280
Volume of Distribution During the Terminal Elimination Phase (Vz) of BIIB144
Measured: Pre-dose and at multiple time points post-dose up to Day 280
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start21 Jul 2026
- Primary completion19 Jun 2028 (estimated)
- Study completion19 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07662148
- Sponsor's protocol ID
- 301HV101
- Status last verified
- Jul 2026
- First submitted
- 18 Jun 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Blinded, Placebo-Controlled, Single Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB144 in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07662148
- Acronym / sponsor ID
- 301HV101
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 21 Jul 2026 (actual)
- Primary completion
- 19 Jun 2028 (estimated)
- Study completion
- 19 Jun 2028 (estimated)
- First posted
- 23 Jun 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.
In this study, researchers will learn how the body processes a study drug called BIIB144. This is a "first-in-human" study. This means that this study drug will be given to people for the first very time in this study. These studies are important because they help researchers learn about the safety of the study drug, how the body processes it, and what dose might be appropriate before testing it in larger groups.
The main goal of this study is to learn more about the safety of a single dose of BIIB144 compared to a placebo. A placebo is something that looks like the study drug but does not contain any medicine. A placebo is also given in the same way as the study drug.
The main question researchers want to answer in this study is:
How many participants have adverse events (AEs) and serious adverse events (SAEs)? An AE is a health problem that may or may not be caused by the study drug.
Researchers will also learn more about:
- How the body processes BIIB144 compared to placebo.
This study will be done as follows:
- Participants will be screened to check if they can join the study. The screening period will be up to 28 days, after which eligible participants will check into their study research center.
- Participants will stay at their study research center for about 8 days. Afterwards, they will have up to 13 visits to their study research center.
- This will be a "dose escalation" study. In this kind of study, increasing amounts of study drug are given to different groups of participants. Usually, this is done until researchers find the highest dose that does not cause harmful effects. In this study, the number of dose groups and maximum dose are planned in advance. The dose escalation will stop once these planned groups are done or if safety concerns arise.
- There will be a total of 6 groups. In each group, participants will receive a single dose of either BIIB144 or the placebo through an intravenous (IV) needle.
- Throughout the study, participants will give blood and urine samples. Participants will also have physical exams and answer questions about how they are feeling.
- Each participant will be in the study for up to 44 weeks.
Detailed description
The primary objective of this study is to evaluate the safety and tolerability of IV administered ascending single doses of BIIB144 compared with placebo in healthy adult participants. The secondary objective is to characterize the pharmacokinetics (PK) of IV administered ascending single doses of BIIB144 in healthy adult participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| BIIB144 Cohort 1 | Experimental | Drug: BIIB144, Drug: PlaceboParticipants will receive Dose A of BIIB144 or a matching placebo via intravenous (IV) infusion on Day 1. |
| BIIB144 Cohort 2 | Experimental | Drug: BIIB144, Drug: PlaceboParticipants will receive Dose B of BIIB144 or a matching placebo via IV infusion on Day 1. |
| BIIB144 Cohort 3 | Experimental | Drug: BIIB144, Drug: PlaceboParticipants will receive Dose C of BIIB144 or a matching placebo via IV infusion on Day 1. |
| BIIB144 Cohort 4 | Experimental | Drug: BIIB144, Drug: PlaceboParticipants will receive Dose D of BIIB144 or a matching placebo via IV infusion on Day 1. |
| BIIB144 Cohort 5 | Experimental | Drug: BIIB144, Drug: PlaceboParticipants will receive Dose E of BIIB144 or a matching placebo via IV infusion on Day 1. |
| BIIB144 Cohort 6 | Experimental | Drug: BIIB144, Drug: PlaceboParticipants will receive Dose F of BIIB144 or a matching placebo via IV infusion on Day 1. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Have a body mass index (BMI) between 18 and 32 kilograms per square metre (kg/m^2), inclusive, at Screening.
- Must be in good health as determined by the Investigator, based on medical history and Screening evaluations.
Key exclusion criteria (6 listed)
- History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
- History of severe allergic or anaphylactic reactions, or of any allergic reactions that in the opinion of the Investigator are likely to be exacerbated by any component of the study treatment.
- History of, or ongoing, malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell carcinomas and squamous cell carcinomas that have been completely excised and considered cured at least 1 year prior to Day -1).
- History of, or positive test result at Screening for, human immunodeficiency virus (HIV).
- Any live or attenuated immunization or vaccination given within 14 days prior to Screening, between Screening and Day -1, or planned to be given during the study period.
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 |
|---|---|---|
| BIIB144Administered IV | Drug | BIIB144 Cohort 1, BIIB144 Cohort 2, BIIB144 Cohort 3, BIIB144 Cohort 4, BIIB144 Cohort 5, BIIB144 Cohort 6 |
| PlaceboAdministered IV | Drug | BIIB144 Cohort 1, BIIB144 Cohort 2, BIIB144 Cohort 3, BIIB144 Cohort 4, BIIB144 Cohort 5, BIIB144 Cohort 6 |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Up to Day 280
7 secondary outcomes
Area Under the Serum Concentration-Time Curve From Time Zero to Time of the Last Measurable Concentration (AUC0-last) of BIIB144
Time frame: Pre-dose and at multiple time points post-dose up to Day 280
Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of BIIB144
Time frame: Pre-dose and at multiple time points post-dose up to Day 280
Maximum Observed Serum Concentration (Cmax) of BIIB144
Time frame: Pre-dose and at multiple time points post-dose up to Day 280
Time to Maximum Observed Serum Concentration (Tmax) of BIIB144
Time frame: Pre-dose and at multiple time points post-dose up to Day 280
Terminal Elimination Half-Life (t½) of BIIB144
Time frame: Pre-dose and at multiple time points post-dose up to Day 280
Total Body Clearance (CL) of BIIB144
Time frame: Pre-dose and at multiple time points post-dose up to Day 280
Volume of Distribution During the Terminal Elimination Phase (Vz) of BIIB144
Time frame: Pre-dose and at multiple time points post-dose up to Day 280
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 27 Jul 2026.
- Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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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.
Global Biogen Clinical Trial Center contact
Medical Director study director
Biogen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BIIB144 in people with Healthy Volunteer, run by Biogen at 1 site in United States.
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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 US Biogen Clinical Trial Center (866-633-4636, clinicaltrials@biogen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: Up to Day 280). 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 27 Jul 2026.