Healthy VolunteerPhase 1NCT07133828
A Study to Learn About the Safety of BIIB142 and How it is Processed in the Body of Healthy Adult Participants Aged 18 to 55 Years Old
A Phase 1 study testing BIIB142 in people with Healthy Volunteer, run by Biogen at 1 site in United States.
Trial summary
In this study, researchers will learn more about the safety of BIIB142 and how it is processed in the body. This is the first time that researchers will learn about BIIB142 and how it affects people. 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?
- BIIB142
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2025to 6 Aug 2026
- 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 between 18 and 32 kilograms per square meter (kg/m^2), inclusive, at screening.
- Weight ≥ 50 kilograms (kg) at screening.
- Negative polymerase chain reaction (PCR) test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at Check-in prior to randomization.
- Must be in good health as determined by the Investigator.
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
- History of or ongoing malignant disease (with limited exceptions)
- Systolic blood pressure >150 millimeters of mercury (mmHg) or <90 mmHg.
- Clinically significant (as determined by the Investigator) electrocardiogram (ECG) abnormalities.
- History of or positive test for human immunodeficiency virus (HIV).
Show all 12Show fewer
- Chronic, recurrent, or serious infection within 90 days prior to Screening.
- Symptoms of bacterial, fungal, or viral infection within 14 days prior to Screening.
- Any live or attenuated immunization within 14 days prior to Screening.
- Use of prescription medications, over-the-counter medications that alter hepatic or renal clearance, or nutraceuticals within 28 days prior to Check-in.
- MAD Cohorts only: Suicidal ideation with some intent to act within 6 months prior to the start of Screening or history of suicidal behavior within one year prior to Screening.
- 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
PPD Development, LP
Las Vegas, Nevada, 89113
702-963-1600
Shawn Searle
About this study
Official title: A Phase 1, Randomized, Blinded, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB142 in Healthy Adults
In this study, researchers will learn more about the safety of BIIB142 and how it is processed in the body. This is the first time that researchers will learn about BIIB142 and how it affects people.
The main question researchers want to answer in this study is:
Read more
- 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 a drug during the study. An AE is considered serious when it results in death, is life-threatening, causes lasting problems, or requires hospital care.
Researchers will also learn more about:
- How the body processes BIIB142
This is a "dose escalation study." This is a study in which increasing amounts of the study drug are given to different groups of participants. This is done until researchers find the highest dose that does not cause harmful effects.
First, participants will be screened to check if they can join the study. The screening period will be up to 28 days. This study will be split into 2 parts - Part A and Part B.
During Part A:
- Participants will be randomly placed into 1 of 6 groups to receive a single dose of either BIIB142 or a placebo. A placebo looks like the study drug but contains no real medicine.
- Participants in Groups 1 through 5 will take either BIIB142 or the placebo without food. Participants in Group 6 will take 2 doses of their assigned treatment - once with food and once without food.
- Neither the researchers nor the participants will know if the participants will receive BIIB142 or the placebo.
- Participants will stay at their study research center for 5 days. They will return for another 4 visits. Each participant in Part A will be in the study for up to 58 days.
During Part B:
- Participants will be randomly placed into 1 of 3 groups to receive BIIB142 or the placebo. In Part B, participants will take BIIB142 or the placebo once a day for 14 days.
- Neither the researchers nor the participants will know if the participants will receive BIIB142 or the placebo.
- Participants will stay at their study research center for 16 days. They will return for another 4 visits. Each participant in Part B will be in the study for up to 58 days.
Read the detailed description
The primary objective of this study is to evaluate the safety and tolerability of single and multiple ascending oral doses of BIIB142 in healthy adult participants.
The secondary objective of this study is to evaluate the pharmacokinetics (PK) profile of single and multiple ascending oral doses of BIIB142 in healthy adult participants.
- Conditions
- Healthy Volunteer
- Being tested
- BIIB142, BIIB142-Matching Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB142Drug
Administered Orally
BIIB142-Matching PlaceboDrug
Administered Orally
| Study group | Role | What they receive |
|---|---|---|
| Part A [Single Ascending Dose (SAD)]: BIIB142 Cohort 1A | Experimental | Participants will receive Dose A of BIIB142 or a matching placebo on Day 1 in a fasted state. Receives: Drug: BIIB142; Drug: BIIB142-Matching Placebo |
| Part A (SAD): BIIB142 Cohort 2A | Experimental | Participants will receive Dose B of BIIB142 or a matching placebo on Day 1 in a fasted state. Receives: Drug: BIIB142; Drug: BIIB142-Matching Placebo |
| Part A (SAD): BIIB142 Cohort 3A | Experimental | Participants will receive Dose C of BIIB142 or a matching placebo on Day 1 in a fasted state. Receives: Drug: BIIB142; Drug: BIIB142-Matching Placebo |
| Part A (SAD): BIIB142 Cohort 4A | Experimental | Participants will receive Dose D of BIIB142 or a matching placebo on Day 1 in a fasted state. Receives: Drug: BIIB142; Drug: BIIB142-Matching Placebo |
| Part A (SAD): BIIB142 Cohort 5A | Experimental | Participants will receive Dose E of BIIB142 or a matching placebo on Day 1 in a fasted state. Receives: Drug: BIIB142; Drug: BIIB142-Matching Placebo |
| Part A (SAD): BIIB142 Cohort 6A | Experimental | Participants will receive BIIB142 on Day 1 in the fasted followed by fed state in the first sequence, and vice versa in the second sequence. A washout period of 14 days will be maintained between both the sequences. Dose will be determined based on emerging PK data. Receives: Drug: BIIB142 |
| Part B [Multiple Ascending Dose (MAD)]: BIIB142 Cohort 1B | Experimental | Participants will receive Dose A of BIIB142 or a matching placebo administered orally once daily for 14 days in a fasted state. Receives: Drug: BIIB142; Drug: BIIB142-Matching Placebo |
| Part B (MAD): BIIB142 Cohort 2B | Experimental | Participants will receive Dose F of BIIB142 or a matching placebo administered orally once daily for 14 days in a fasted state. Receives: Drug: BIIB142; Drug: BIIB142-Matching Placebo |
| Part B (MAD): BIIB142 Cohort 3B | Experimental | Participants will receive Dose D of BIIB142 or a matching placebo administered orally once daily for 14 days in a fasted state. Receives: Drug: BIIB142; Drug: BIIB142-Matching 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: Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29
Number of Participants with Clinical Laboratory Abnormalities
Measured: Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29
Number of Participants with Potentially Clinically Relevant Abnormalities in Vital Sign Parameters
Measured: Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score
Measured: Part B (MAD): Up to Day 29
Number of Participants With Potentially Clinically Relevant Abnormalities in 12-lead Electrocardiogram (ECG) Parameters
Measured: Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29
Secondary outcomes (7)
Plasma Concentration of BIIB142
Measured: Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29]
Area Under the Concentration-Time Curve (AUC) of BIIB142
Measured: Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29]
Maximum Observed Concentration (Cmax) of BIIB142
Measured: Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29]
Time to Maximum Observed Concentration (Tmax) of BIIB142
Measured: Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29]
Apparent Clearance (CL/F) of BIIB142
Measured: Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29]
Apparent Volume of Distribution (Vz/F) of BIIB142
Measured: Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29]
Elimination Half-Life (t1/2) of BIIB142
Measured: Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start29 Aug 2025
- Primary completion6 Aug 2026 (estimated)
- Study completion6 Aug 2026 (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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 78 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
- NCT07133828
- Sponsor's protocol ID
- 300HV101
- Status last verified
- Apr 2026
- First submitted
- 14 Aug 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Blinded, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB142 in Healthy Adults
- ClinicalTrials.gov ID
- NCT07133828
- Acronym / sponsor ID
- 300HV101
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 29 Aug 2025 (actual)
- Primary completion
- 6 Aug 2026 (estimated)
- Study completion
- 6 Aug 2026 (estimated)
- First posted
- 21 Aug 2025 (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 more about the safety of BIIB142 and how it is processed in the body. This is the first time that researchers will learn about BIIB142 and how it affects people.
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 a drug during the study. An AE is considered serious when it results in death, is life-threatening, causes lasting problems, or requires hospital care.
Researchers will also learn more about:
- How the body processes BIIB142
This is a "dose escalation study." This is a study in which increasing amounts of the study drug are given to different groups of participants. This is done until researchers find the highest dose that does not cause harmful effects.
First, participants will be screened to check if they can join the study. The screening period will be up to 28 days. This study will be split into 2 parts - Part A and Part B.
During Part A:
- Participants will be randomly placed into 1 of 6 groups to receive a single dose of either BIIB142 or a placebo. A placebo looks like the study drug but contains no real medicine.
- Participants in Groups 1 through 5 will take either BIIB142 or the placebo without food. Participants in Group 6 will take 2 doses of their assigned treatment - once with food and once without food.
- Neither the researchers nor the participants will know if the participants will receive BIIB142 or the placebo.
- Participants will stay at their study research center for 5 days. They will return for another 4 visits. Each participant in Part A will be in the study for up to 58 days.
During Part B:
- Participants will be randomly placed into 1 of 3 groups to receive BIIB142 or the placebo. In Part B, participants will take BIIB142 or the placebo once a day for 14 days.
- Neither the researchers nor the participants will know if the participants will receive BIIB142 or the placebo.
- Participants will stay at their study research center for 16 days. They will return for another 4 visits. Each participant in Part B will be in the study for up to 58 days.
Detailed description
The primary objective of this study is to evaluate the safety and tolerability of single and multiple ascending oral doses of BIIB142 in healthy adult participants.
The secondary objective of this study is to evaluate the pharmacokinetics (PK) profile of single and multiple ascending oral doses of BIIB142 in healthy adult participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Part A [Single Ascending Dose (SAD)]: BIIB142 Cohort 1A | Experimental | Drug: BIIB142, Drug: BIIB142-Matching PlaceboParticipants will receive Dose A of BIIB142 or a matching placebo on Day 1 in a fasted state. |
| Part A (SAD): BIIB142 Cohort 2A | Experimental | Drug: BIIB142, Drug: BIIB142-Matching PlaceboParticipants will receive Dose B of BIIB142 or a matching placebo on Day 1 in a fasted state. |
| Part A (SAD): BIIB142 Cohort 3A | Experimental | Drug: BIIB142, Drug: BIIB142-Matching PlaceboParticipants will receive Dose C of BIIB142 or a matching placebo on Day 1 in a fasted state. |
| Part A (SAD): BIIB142 Cohort 4A | Experimental | Drug: BIIB142, Drug: BIIB142-Matching PlaceboParticipants will receive Dose D of BIIB142 or a matching placebo on Day 1 in a fasted state. |
| Part A (SAD): BIIB142 Cohort 5A | Experimental | Drug: BIIB142, Drug: BIIB142-Matching PlaceboParticipants will receive Dose E of BIIB142 or a matching placebo on Day 1 in a fasted state. |
| Part A (SAD): BIIB142 Cohort 6A | Experimental | Drug: BIIB142Participants will receive BIIB142 on Day 1 in the fasted followed by fed state in the first sequence, and vice versa in the second sequence. A washout period of 14 days will be maintained between both the sequences. Dose will be determined based on emerging PK data. |
| Part B [Multiple Ascending Dose (MAD)]: BIIB142 Cohort 1B | Experimental | Drug: BIIB142, Drug: BIIB142-Matching PlaceboParticipants will receive Dose A of BIIB142 or a matching placebo administered orally once daily for 14 days in a fasted state. |
| Part B (MAD): BIIB142 Cohort 2B | Experimental | Drug: BIIB142, Drug: BIIB142-Matching PlaceboParticipants will receive Dose F of BIIB142 or a matching placebo administered orally once daily for 14 days in a fasted state. |
| Part B (MAD): BIIB142 Cohort 3B | Experimental | Drug: BIIB142, Drug: BIIB142-Matching PlaceboParticipants will receive Dose D of BIIB142 or a matching placebo administered orally once daily for 14 days in a fasted state. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Have a body mass index between 18 and 32 kilograms per square meter (kg/m^2), inclusive, at screening.
- Weight ≥ 50 kilograms (kg) at screening.
- Negative polymerase chain reaction (PCR) test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at Check-in prior to randomization.
- Must be in good health as determined by the Investigator.
Key exclusion criteria (12 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
- History of or ongoing malignant disease (with limited exceptions)
- Systolic blood pressure >150 millimeters of mercury (mmHg) or <90 mmHg.
- Clinically significant (as determined by the Investigator) electrocardiogram (ECG) abnormalities.
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 |
|---|---|---|
| BIIB142Administered Orally | Drug | Part A (SAD): BIIB142 Cohort 2A, Part A (SAD): BIIB142 Cohort 3A, Part A (SAD): BIIB142 Cohort 4A, Part A (SAD): BIIB142 Cohort 5A, Part A (SAD): BIIB142 Cohort 6A, Part A [Single Ascending Dose (SAD)]: BIIB142 Cohort 1A, Part B (MAD): BIIB142 Cohort 2B, Part B (MAD): BIIB142 Cohort 3B, Part B [Multiple Ascending Dose (MAD)]: BIIB142 Cohort 1B |
| BIIB142-Matching PlaceboAdministered Orally | Drug | Part A (SAD): BIIB142 Cohort 2A, Part A (SAD): BIIB142 Cohort 3A, Part A (SAD): BIIB142 Cohort 4A, Part A (SAD): BIIB142 Cohort 5A, Part A [Single Ascending Dose (SAD)]: BIIB142 Cohort 1A, Part B (MAD): BIIB142 Cohort 2B, Part B (MAD): BIIB142 Cohort 3B, Part B [Multiple Ascending Dose (MAD)]: BIIB142 Cohort 1B |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29
Number of Participants with Clinical Laboratory Abnormalities
Time frame: Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29
Number of Participants with Potentially Clinically Relevant Abnormalities in Vital Sign Parameters
Time frame: Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score
Time frame: Part B (MAD): Up to Day 29
Number of Participants With Potentially Clinically Relevant Abnormalities in 12-lead Electrocardiogram (ECG) Parameters
Time frame: Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29
7 secondary outcomes
Plasma Concentration of BIIB142
Time frame: Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29]
Area Under the Concentration-Time Curve (AUC) of BIIB142
Time frame: Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29]
Maximum Observed Concentration (Cmax) of BIIB142
Time frame: Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29]
Time to Maximum Observed Concentration (Tmax) of BIIB142
Time frame: Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29]
Apparent Clearance (CL/F) of BIIB142
Time frame: Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29]
Apparent Volume of Distribution (Vz/F) of BIIB142
Time frame: Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29]
Elimination Half-Life (t1/2) of BIIB142
Time frame: Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29]
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 6 May 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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Screening Protocol
Pain
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 BIIB142 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 4 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: looking for participants now, as of the sponsor's last update on 6 May 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: Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29). The study lists 5 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 6 May 2026.