Healthy VolunteerPhase 1NCT05195008
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics, With Target Occupancy Study of BIIB113 in Healthy Participants
A Phase 1 study testing BIIB113 and 11^C]BIO-1819578 in people with Healthy Volunteer, run by Biogen at 3 sites in 2 countries.
Trial summary
Parts A and B: The primary objective of this study is to evaluate the safety and tolerability of single and multiple ascending oral doses of BIIB113 in healthy participants. The secondary objectives of this study are to evaluate the single and multiple oral dose pharmacokinetic (PK) profile of BIIB113 in healthy… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- BIIB113 and 11^C]BIO-1819578
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 24 Jan 2022to 10 Jul 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female or infertile/vasectomized males aged 18 to 64 years (Parts A and B), 20 to 64 years (Part C), or 65 to 75 years (Part B Dose 7Cohort 9 only), inclusive, at the time of informed consent
- 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) within 5 days of Day -1 prior to randomization
Who cannot join
- History or positive test result at Screening for Human Immunodeficiency Virus (HIV)
- Chronic, recurrent, or serious infection (e.g., pneumonia, septicemia), as determined by the investigator, within 90 days prior to screening or between screening and Day -1
- 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 systemic hypersensitivity reaction to BIIB113 or the excipients contained in the formulation, and if appropriate, any diagnostic agents to be administered during the study
- Has suicidal ideation with some intent to act within 6 months prior to the start of screening, per the investigator's clinical judgment or based on the C-SSRS, corresponding to a response of "Yes" on Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) for suicidal ideation on the C-SSRS, or a history of suicidal behaviour within one year prior to the start of screening.
- Any condition affecting study treatment absorption (e.g., gastrectomy)
Show all 10Show fewer
- Previous exposure to an OGA inhibitor
- Current enrolment in any other drug, biologic, device, or clinical study, or treatment with an investigational drug or approved therapy for investigational use within 90 days (6 months for biologics) prior to Day -1, or 5 half-lives of the agent, whichever is longer
- For Part C only: Previously undergone PET scans for research purposes
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United Kingdom2 sites
Hammersmith Medicine Research
London, Brent, NW10 7EW
Medicines Evaluation Unit
Wythenshawe, Manchester, M23 9QZ
Sweden1 site
Karolinska Comprehensive Cancer Center - Studieenheten
Flemingsberg, Stockholm County, 14186
About this study
Official title: A Phase 1 Randomized, Blinded, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics, With an Open-Label Target Occupancy Study of BIIB113 in Healthy Participants
Parts A and B: The primary objective of this study is to evaluate the safety and tolerability of single and multiple ascending oral doses of BIIB113 in healthy participants. The secondary objectives of this study are to evaluate the single and multiple oral dose pharmacokinetic (PK) profile of BIIB113 in healthy participants and to evaluate the effect of food on the single oral dose of BIIB113 in healthy participants of Part A cohort 3.
Part C: The primary objectives of this study are to evaluate the safety and tolerability of single and multiple ascending oral doses of BIIB113 in healthy participants and to determine target occupancy (TO) as measured by O-GlcNAcase-Positron Emission Tomography (OGA-PET) of single and multiple oral doses of BIIB113 in healthy participants.
Read the detailed description
BIIB113 is a small molecule inhibitor of OGA being evaluated in Alzheimer's disease.
- Conditions
- Healthy Volunteer
- Being tested
- BIIB113, BIIB113-Matching Placebo, 11^C]BIO-1819578
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB113Drug
Administered as specified in the treatment arm.
BIIB113-Matching PlaceboDrug
Administered as specified in the treatment arm.
11^C]BIO-1819578Drug
Administered as specified in the treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| Part A [Single Ascending Dose (SAD)]: BIIB113 Cohort 1 | Experimental | Participants aged 18 to 64 years will receive Dose 1 of BIIB113, orally, once daily (QD), on Day 1 of Part A of the study. Receives: Drug: BIIB113 |
| Part A (SAD): BIIB113 Cohort 2 | Experimental | Participants aged 18 to 64 years will receive Dose 2 of BIIB113, orally, QD, on Day 1 of Part A of the study Receives: Drug: BIIB113 |
| Part A (SAD): BIIB113 Cohort 3 | Experimental | Participants aged 18 to 64 years will receive Dose 3 of BIIB113, orally, QD, on Day 1 of Part A of the study. Receives: Drug: BIIB113 |
| Part A (SAD): BIIB113 Cohort 4 | Experimental | Participants aged 18 to 64 years will receive Dose 4 of BIIB113, orally, QD, on Day 1 of Part A of the study. Receives: Drug: BIIB113 |
| Part A (SAD): BIIB113 Cohort 5 | Experimental | Participants aged 18 to 64 years will receive Dose 5 of BIIB113, orally, QD, on Day 1 of Part A of the study Receives: Drug: BIIB113 |
| Part A (SAD): BIIB113-Matching Placebo (Cohorts 1-5) | Placebo comparator | Participants aged 18 to 64 years will receive BIIB113-matching placebo, orally, QD, on Day 1 of Part A of the study. Receives: Drug: BIIB113-Matching Placebo |
| Part B [Multiple Ascending Dose (MAD)]: BIIB113 Cohort 6 | Experimental | Participants aged 18 to 64 years will receive Dose 3 of BIIB113, orally, QD, up to Day 14 of Part B of the study. Receives: Drug: BIIB113 |
| Part B (MAD): BIIB113 Cohort 7 | Experimental | Participants aged 18 to 64 years will receive Dose 4 of BIIB113, orally, QD, on Days 1 to 14 of Part B of the study. Receives: Drug: BIIB113 |
| Part B (MAD): BIIB113 Cohort 8 | Experimental | Participants aged 18 to 64 years will receive Dose 6 of BIIB113, orally, QD, on Days 1 to 14 of Part B of the study. Receives: Drug: BIIB113 |
| Part B (MAD): BIIB113 Cohort 9 | Placebo comparator | Participants aged 65 to 75 years will receive BIIB113, orally, QD, on Days 1 to 14 of Part B of the study. The calculated dose level will be adaptive by design based on review of the safety, tolerability, and PK data from Cohorts 1 to 7. Receives: Drug: BIIB113 |
| Part B (MAD): BIIB113-Matching Placebo (Cohorts 6 to 9) | Placebo comparator | Participants aged 18 to 75 will receive BIIB113-matching placebo, orally, QD, on Days 1 to 14 of Part B of the study. Receives: Drug: BIIB113-Matching Placebo |
| Part C (OGA-PET SAD): BIIB113 | Experimental | Participants aged 20 to 64 will receive single dose of BIIB113, orally, QD, on Day 1 of Part C of the study, followed by a radiotracer specific to OGA ([11^C]BIO-1819578), on Days 1 to 4 of Part C of the study. Receives: Drug: BIIB113; Drug: 11^C]BIO-1819578 |
| Part C (OGA-PET MAD): BIIB113 | Experimental | Participants aged 20 to 64 years will receive multiple doses of BIIB113, orally, QD, on Days 1 to 14 of Part C of the study, followed by a radiotracer specific to OGA ([11^C]BIO-1819578) on Day 1 and either of Day 15, Day 16 or Day 17 of Part C of the study. Receives: Drug: BIIB113; Drug: 11^C]BIO-1819578 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parts A, B and C: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death; in the view of the investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect or is a medically important event.
Measured: Part A: Up to 54 days; Part B: Up to 53 days; Part C: Up to 71 days (SAD); Up to 85 days (MAD)
Parts A, B and C: Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Parameters, Vital Signs, and 12-Lead Electrocardiogram (ECG)
Measured: Part A: Baseline up to 54 days; Part B: Baseline up to 53 days; Part C: Baseline up to 71 days (SAD), Baseline up to 85 days (MAD)
Parts A, B and C: Number of Participants With Change in Columbia Suicide Severity Rating Scale (C-SSRS) Score
C-SSRS is used to assess the suicidality of participants during the study. The assessment includes "yes" or "no" responses for 5 questions each, related to suicidal ideation (wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods, active suicidal ideation with some intent, active suicidal ideation with specific plan) and suicidal behavior (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, suicide). Numeric ratings are provided for severity of ideation, from 1 to 5, with 5 being the most severe.
Measured: Part A: Up to 54 days; Part B: Up to 53 days; Part C: Up to 71 days (SAD); Up to 85 days (MAD)
Part C: Percent O-GlcNAcase-Positron Emission Tomography (OGA PET) Target Engagement/Occupancy (TO) as a Function of Dose and Time
Measured: Up to Day 4 (SAD); Up to Day 17 (MAD)
Secondary outcomes (12)
Parts A and B: Area Under the Concentration-Time Curve From Time Zero to Time of the Last Measurable Concentration (AUClast) of BIIB113
The parameter will be assessed under fed conditions for Part A Cohort 3.
Measured: Part A: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part B: Pre-dose and at multiple timepoints post-dose on Days 1 to 15
Parts A and B: Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC∞) of BIIB113
The parameter will be assessed under fed conditions for Part A Cohort 3.
Measured: Part A: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part B: Pre-dose and at multiple timepoints post-dose on Days 1 to 15
Parts A and B: Area Under the Plasma Concentration-Time Curve Within a Dosing Interval (AUCtau) of BIIB113
The parameter will be assessed under fed conditions for Part A Cohort 3.
Measured: Part A: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part B: Pre-dose and at multiple timepoints post-dose on Days 1 to 15
Parts A and B: Maximum Observed Concentration (Cmax) for BIIB113
The parameter will be assessed under fed conditions for Part A Cohort 3.
Measured: Part A: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part B: Pre-dose and at multiple timepoints post-dose on Days 1 to 15
Parts A and B: Trough Concentration (Ctrough) of BIIB113
The parameter will be assessed under fed conditions for Part A Cohort 3.
Measured: Part A: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part B: Pre-dose and at multiple timepoints post-dose on Days 1 to 15
Parts A and B: Time to Maximum Observed Concentration (Tmax) of BIIB113
The parameter will be assessed under fed conditions for Part A Cohort 3.
Measured: Part A: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part B: Pre-dose and at multiple timepoints post-dose on Days 1 to 15
Parts A and B: Terminal Elimination Half-Life (t½) of BIIB113
t1/2 is the time measured for the plasma concentration to decrease by one half. The parameter will be assessed under fed conditions for Part A Cohort 3.
Measured: Part A: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part B: Pre-dose and at multiple timepoints post-dose on Days 1 to 15
Parts A and B: Apparent Total Body Clearance (CL/F) of BIIB113
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. If the bioavailability (F) of a dose is assumed to be 100% or equivalently, that clearance is the apparent clearance (CL/F) when the ratio of clearance to bioavailability is assumed to be constant.
The parameter will be assessed under fed conditions for Part A Cohort 3.
Measured: Part A: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part B: Pre-dose and at multiple timepoints post-dose on Days 1 to 15
Parts A and B: Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of BIIB113
Volume of distribution is defined as the apparent volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
The parameter will be assessed under fed conditions for Part A Cohort 3.
Measured: Part A: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part B: Pre-dose and at multiple timepoints post-dose on Days 1 to 15
Parts A and B: Accumulation Ratio (AR) of BIIB113
The parameter will be assessed under fed conditions for Part A Cohort 3.
Measured: Part A: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part B: Pre-dose and at multiple timepoints post-dose on Days 1 to 15
Parts A and B: Amount of BIIB113 Excreted in Urine (Aeu)
The parameter will be assessed under fed conditions for Part A Cohort 3.
Measured: Part A: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part B: Pre-dose and at multiple timepoints post-dose on Days 1 to 15
Parts A and B: Percentage of BIIB113 Excreted in Urine (%fe)
The parameter will be assessed under fed conditions for Part A Cohort 3.
Measured: Part A: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part B: Pre-dose and at multiple timepoints post-dose on Days 1 to 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start24 Jan 2022
- Primary completion10 Jul 2023
- Study completion10 Jul 2023
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
- 72 participants (actual)
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
- NCT05195008
- Sponsor's protocol ID
- 276HV101
- Other IDs
- 2021-002903-36
- Status last verified
- Feb 2024
- First submitted
- 4 Jan 2022
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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 5 Feb 2024. 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 Evaluate the Safety, Tolerability, and Pharmacokinetics, With an Open-Label Target Occupancy Study of BIIB113 in Healthy Participants
- ClinicalTrials.gov ID
- NCT05195008
- Acronym / sponsor ID
- 276HV101
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 18 Jan 2022 (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.
Parts A and B: The primary objective of this study is to evaluate the safety and tolerability of single and multiple ascending oral doses of BIIB113 in healthy participants. The secondary objectives of this study are to evaluate the single and multiple oral dose pharmacokinetic (PK) profile of BIIB113 in healthy participants and to evaluate the effect of food on the single oral dose of BIIB113 in healthy participants of Part A cohort 3.
Part C: The primary objectives of this study are to evaluate the safety and tolerability of single and multiple ascending oral doses of BIIB113 in healthy participants and to determine target occupancy (TO) as measured by O-GlcNAcase-Positron Emission Tomography (OGA-PET) of single and multiple oral doses of BIIB113 in healthy participants.
Detailed description
BIIB113 is a small molecule inhibitor of OGA being evaluated in Alzheimer's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| Part A [Single Ascending Dose (SAD)]: BIIB113 Cohort 1 | Experimental | Drug: BIIB113Participants aged 18 to 64 years will receive Dose 1 of BIIB113, orally, once daily (QD), on Day 1 of Part A of the study. |
| Part A (SAD): BIIB113 Cohort 2 | Experimental | Drug: BIIB113Participants aged 18 to 64 years will receive Dose 2 of BIIB113, orally, QD, on Day 1 of Part A of the study |
| Part A (SAD): BIIB113 Cohort 3 | Experimental | Drug: BIIB113Participants aged 18 to 64 years will receive Dose 3 of BIIB113, orally, QD, on Day 1 of Part A of the study. |
| Part A (SAD): BIIB113 Cohort 4 | Experimental | Drug: BIIB113Participants aged 18 to 64 years will receive Dose 4 of BIIB113, orally, QD, on Day 1 of Part A of the study. |
| Part A (SAD): BIIB113 Cohort 5 | Experimental | Drug: BIIB113Participants aged 18 to 64 years will receive Dose 5 of BIIB113, orally, QD, on Day 1 of Part A of the study |
| Part A (SAD): BIIB113-Matching Placebo (Cohorts 1-5) | Placebo comparator | Drug: BIIB113-Matching PlaceboParticipants aged 18 to 64 years will receive BIIB113-matching placebo, orally, QD, on Day 1 of Part A of the study. |
| Part B [Multiple Ascending Dose (MAD)]: BIIB113 Cohort 6 | Experimental | Drug: BIIB113Participants aged 18 to 64 years will receive Dose 3 of BIIB113, orally, QD, up to Day 14 of Part B of the study. |
| Part B (MAD): BIIB113 Cohort 7 | Experimental | Drug: BIIB113Participants aged 18 to 64 years will receive Dose 4 of BIIB113, orally, QD, on Days 1 to 14 of Part B of the study. |
| Part B (MAD): BIIB113 Cohort 8 | Experimental | Drug: BIIB113Participants aged 18 to 64 years will receive Dose 6 of BIIB113, orally, QD, on Days 1 to 14 of Part B of the study. |
| Part B (MAD): BIIB113 Cohort 9 | Placebo comparator | Drug: BIIB113Participants aged 65 to 75 years will receive BIIB113, orally, QD, on Days 1 to 14 of Part B of the study. The calculated dose level will be adaptive by design based on review of the safety, tolerability, and PK data from Cohorts 1 to 7. |
| Part B (MAD): BIIB113-Matching Placebo (Cohorts 6 to 9) | Placebo comparator | Drug: BIIB113-Matching PlaceboParticipants aged 18 to 75 will receive BIIB113-matching placebo, orally, QD, on Days 1 to 14 of Part B of the study. |
| Part C (OGA-PET SAD): BIIB113 | Experimental | Drug: BIIB113, Drug: 11^C]BIO-1819578Participants aged 20 to 64 will receive single dose of BIIB113, orally, QD, on Day 1 of Part C of the study, followed by a radiotracer specific to OGA ([11^C]BIO-1819578), on Days 1 to 4 of Part C of the study. |
| Part C (OGA-PET MAD): BIIB113 | Experimental | Drug: BIIB113, Drug: 11^C]BIO-1819578Participants aged 20 to 64 years will receive multiple doses of BIIB113, orally, QD, on Days 1 to 14 of Part C of the study, followed by a radiotracer specific to OGA ([11^C]BIO-1819578) on Day 1 and either of Day 15, Day 16 or Day 17 of Part C of the study. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female or infertile/vasectomized males aged 18 to 64 years (Parts A and B), 20 to 64 years (Part C), or 65 to 75 years (Part B Dose 7Cohort 9 only), inclusive, at the time of informed consent
- 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) within 5 days of Day -1 prior to randomization
Key exclusion criteria (10 listed)
- History or positive test result at Screening for Human Immunodeficiency Virus (HIV)
- Chronic, recurrent, or serious infection (e.g., pneumonia, septicemia), as determined by the investigator, within 90 days prior to screening or between screening and Day -1
- 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 systemic hypersensitivity reaction to BIIB113 or the excipients contained in the formulation, and if appropriate, any diagnostic agents to be administered during the study
- Has suicidal ideation with some intent to act within 6 months prior to the start of screening, per the investigator's clinical judgment or based on the C-SSRS, corresponding to a response of "Yes" on Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) for suicidal ideation on the C-SSRS, or a history of suicidal behaviour within one year prior to the start of screening.
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 |
|---|---|---|
| BIIB113Administered as specified in the treatment arm. | Drug | Part A (SAD): BIIB113 Cohort 2, Part A (SAD): BIIB113 Cohort 3, Part A (SAD): BIIB113 Cohort 4, Part A (SAD): BIIB113 Cohort 5, Part A [Single Ascending Dose (SAD)]: BIIB113 Cohort 1, Part B (MAD): BIIB113 Cohort 7, Part B (MAD): BIIB113 Cohort 8, Part B (MAD): BIIB113 Cohort 9, Part B [Multiple Ascending Dose (MAD)]: BIIB113 Cohort 6, Part C (OGA-PET MAD): BIIB113, Part C (OGA-PET SAD): BIIB113 |
| BIIB113-Matching PlaceboAdministered as specified in the treatment arm. | Drug | Part A (SAD): BIIB113-Matching Placebo (Cohorts 1-5), Part B (MAD): BIIB113-Matching Placebo (Cohorts 6 to 9) |
| 11^C]BIO-1819578Administered as specified in the treatment arm. | Drug | Part C (OGA-PET MAD): BIIB113, Part C (OGA-PET SAD): BIIB113 |
Primary outcome
Parts A, B and C: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Part A: Up to 54 days; Part B: Up to 53 days; Part C: Up to 71 days (SAD); Up to 85 days (MAD)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death; in the view of the investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect or is a medically important event.
Parts A, B and C: Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Parameters, Vital Signs, and 12-Lead Electrocardiogram (ECG)
Time frame: Part A: Baseline up to 54 days; Part B: Baseline up to 53 days; Part C: Baseline up to 71 days (SAD), Baseline up to 85 days (MAD)
Parts A, B and C: Number of Participants With Change in Columbia Suicide Severity Rating Scale (C-SSRS) Score
Time frame: Part A: Up to 54 days; Part B: Up to 53 days; Part C: Up to 71 days (SAD); Up to 85 days (MAD)
C-SSRS is used to assess the suicidality of participants during the study. The assessment includes "yes" or "no" responses for 5 questions each, related to suicidal ideation (wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods, active suicidal ideation with some intent, active suicidal ideation with specific plan) and suicidal behavior (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, suicide). Numeric ratings are provided for severity of ideation, from 1 to 5, with 5 being the most severe.
Part C: Percent O-GlcNAcase-Positron Emission Tomography (OGA PET) Target Engagement/Occupancy (TO) as a Function of Dose and Time
Time frame: Up to Day 4 (SAD); Up to Day 17 (MAD)
12 secondary outcomes
Parts A and B: Area Under the Concentration-Time Curve From Time Zero to Time of the Last Measurable Concentration (AUClast) of BIIB113
Time frame: Part A: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part B: Pre-dose and at multiple timepoints post-dose on Days 1 to 15
Parts A and B: Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC∞) of BIIB113
Time frame: Part A: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part B: Pre-dose and at multiple timepoints post-dose on Days 1 to 15
Parts A and B: Area Under the Plasma Concentration-Time Curve Within a Dosing Interval (AUCtau) of BIIB113
Time frame: Part A: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part B: Pre-dose and at multiple timepoints post-dose on Days 1 to 15
Parts A and B: Maximum Observed Concentration (Cmax) for BIIB113
Time frame: Part A: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part B: Pre-dose and at multiple timepoints post-dose on Days 1 to 15
Parts A and B: Trough Concentration (Ctrough) of BIIB113
Time frame: Part A: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part B: Pre-dose and at multiple timepoints post-dose on Days 1 to 15
Parts A and B: Time to Maximum Observed Concentration (Tmax) of BIIB113
Time frame: Part A: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part B: Pre-dose and at multiple timepoints post-dose on Days 1 to 15
Parts A and B: Terminal Elimination Half-Life (t½) of BIIB113
Time frame: Part A: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part B: Pre-dose and at multiple timepoints post-dose on Days 1 to 15
Parts A and B: Apparent Total Body Clearance (CL/F) of BIIB113
Time frame: Part A: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part B: Pre-dose and at multiple timepoints post-dose on Days 1 to 15
Parts A and B: Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of BIIB113
Time frame: Part A: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part B: Pre-dose and at multiple timepoints post-dose on Days 1 to 15
Parts A and B: Accumulation Ratio (AR) of BIIB113
Time frame: Part A: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part B: Pre-dose and at multiple timepoints post-dose on Days 1 to 15
Parts A and B: Amount of BIIB113 Excreted in Urine (Aeu)
Time frame: Part A: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part B: Pre-dose and at multiple timepoints post-dose on Days 1 to 15
Parts A and B: Percentage of BIIB113 Excreted in Urine (%fe)
Time frame: Part A: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part B: Pre-dose and at multiple timepoints post-dose on Days 1 to 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Related trials for Healthy Volunteer
Not yet recruitingPhase 1
Comparison of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of GZR101-80 Injection With Separately Injected, Simultaneous Doses of GZR33 Injection and Insulin Aspart
Healthy Participants
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
Active, not recruitingPhase 1
A Comparative Study to Investigate the Difference in Blood Levels of Two Different Formulations of GSK5784283
Asthma
RecruitingPhase 4
Testing Healthy Participants for Drowsiness After Single Dosing of Two Different Doses of Muscle Relaxer
Healthy Participants
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. This study is not recruiting at the moment.
Medical Director study director
Biogen
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BIIB113 and 11^C]BIO-1819578 in people with Healthy Volunteer, run by Biogen at 3 sites in 2 countries.
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 10 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: finished, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom, Sweden. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parts A, B and C: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Part A: Up to 54 days; Part B: Up to 53 days; Part C: Up to 71 days (SAD); Up to 85 days (MAD)). The study lists 4 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 5 Feb 2024.