Clinical trials: sponsored by Biogen
Multiple Sclerosis
Validation of DigiCog and Konectom Tools to Support Digitalized Clinical Assessment in Multiple Sclerosis
The primary objective of this study is to establish scores of Cognitive impairment (CI) of the 3 DigiCog [Brief Computerized Cognitive Assessment for Multiple Sclerosis (BCCAMS) app] tests [Computerized Speed Cognitive Test…
- Trial name
- DigiToms (NCT04756700)
- Testing
- DigiCog (BCCAMS app), Konectom Application
- Where
- France
- Volunteers
- 158 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy Volunteer
A Study to See How BIIB122 Works in the Human Body, and to Evaluate it's Safety, and Tolerability in Healthy Adult Japanese, Chinese, and Caucasian Participants
The study will be looking at an investigational drug, BIIB122, in healthy adult Japanese, Chinese, and Caucasian participants. The main goal of the study is to compare the drug level achieved in the body, between the different…
- Trial name
- NCT05229562
- Testing
- BIIB122
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy Volunteer
A Study to Assess the Pharmacokinetic (PK) Comparability of 2 Fixed Subcutaneous (SC) Doses of Aducanumab (BIIB037) With a Single, Weight-Based Intravenous (IV) Dose in Healthy Volunteers
The primary objective of the study is to evaluate the pharmacokinetic (PK) comparability of 2 fixed subcutaneous (SC) doses of aducanumab with a single, weight-based intravenous (IV) dose of aducanumab in healthy volunteers.
- Trial name
- NCT05216887
- Testing
- Aducanumab
- Where
- 3 sites in United States
- Volunteers
- 123 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy Volunteers
Study of BIIB091 Formulations in Healthy Participants
The primary objectives of this study are: to evaluate the pharmacokinetic (PK) profiles of BIIB091 modified release (MR) formulations in healthy participants after single dose administration in the fasted state (Part 1); to…
- Trial name
- NCT04564612
- Testing
- BIIB091, Rabeprazole, Itraconazole
- Where
- United Kingdom
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy Volunteers
A Study to Evaluate the Relative Bioavailability of Two Formulations of BIIB104 and Assess the Effect of Food on the Pharmacokinetics of BIIB104 Following Administration of a Single, Fixed, Oral Dose of BIIB104 in Healthy Participants
The primary objectives of this study are to evaluate the relative bioavailability of the BIIB104 test formulation compared with the reference formulation in healthy Caucasian male adult participants in the fasted state and to…
- Trial name
- NCT05152485
- Testing
- BIIB104 Reference Formulation, BIIB104 Test Formulation
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy Volunteer
MS PATHS Normative Sub-Study
The primary objective of this study is to determine the normative range of brain volume and brain volume change in healthy control (HC) participants whose age, race, and gender distribution is approximately matched to the age…
- Trial name
- NCT02996084
- Where
- 6 sites in United States, Germany and 1 more
- Volunteers
- 246 people, healthy volunteers welcome
- Sponsor
- Biogen
Systemic Lupus Erythematosus, Healthy Volunteers
Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Single Doses and Multiple Doses of BIIB059 (Litifilimab) in Healthy Volunteers and Participants With Systemic Lupus Erythematosus
The primary objective of Parts 1 and 2 is to evaluate the safety and tolerability of either single-ascending intravenous (IV) doses or a single subcutaneous (SC) dose of BIIB059 (litifilimab) in healthy volunteers (HV), and a…
- Trial name
- NCT02106897
- Testing
- BIIB059 (litifilimab)
- Where
- 5 sites in United States
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy Volunteers
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Diroximel Fumarate (DRF) in Chinese and Caucasian Adult Healthy Participants
The primary objective is to evaluate the primary pharmacokinetic (PK) parameters of DRF active metabolite monomethyl fumarate (MMF) following multiple doses of DRF in Chinese and Caucasian adult healthy participants.
- Trial name
- NCT05127564
- Testing
- Diroximel fumarate
- Where
- 2 sites in Hong Kong, New Zealand
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy Volunteers
A Study of Mass Balance, Pharmacokinetics, Metabolite Profile, and Metabolite Identification of BIIB122/DNL151 in Healthy Male Subjects
This is a single-center, non-randomized, open-label Phase 1 study to determine the absorption, metabolism, and excretion (AME) of BIIB122 (DNL151) following administration of a single oral dose of [14C] BIIB122 ([14C] DNL151)…
- Trial name
- NCT05119790
- Testing
- [14C] BIIB122 ([14C] DNL151)
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy Volunteers
A Study to Determine the Absolute Bioavailability of BIIB122/DNL151 in Healthy Subjects
This is a single center, non-randomized, open label Phase 1 study to determine the PK and absolute bioavailability of BIIB122 (DNL151) in 2 conditions: following a single, oral dose of BIIB122 (DNL151) and following consecutive…
- Trial name
- NCT05005338
- Testing
- BIIB122 (DNL151), [14C] BIIB122 ([14C] DNL151)
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Biogen
Traumatic Brain Injury, Stroke
Safety Study of RP-1127 (Glyburide for Injection) in Healthy Volunteers
The primary objective of this study is to evaluate the safety and tolerability of different dose levels of glyburide for injection, administered as a bolus dose followed by a 3-day continuous infusion.
- Trial name
- NCT01132703
- Testing
- Glyburide for Injection
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy Volunteers
Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB104 in Healthy Japanese and Non-Japanese Participants
The primary objective is to evaluate the pharmacokinetics (PK) of BIIB104 in healthy Japanese and non-Japanese participants. The secondary objective is to evaluate the safety and tolerability of multiple, oral doses of BIIB104…
- Trial name
- NCT04079101
- Testing
- BIIB104
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy Volunteers, Diabetic Neuropathies
Pharmacodynamic Study of BIIB095 and BIIB074 in Healthy Participants and Participants With Painful Diabetic Polyneuropathy
Part A: Primary objective is to determine the effects of BIIB095 on nerve excitability in healthy participants. Secondary and exploratory objectives include determining the effects of BIIB095 on nerve excitability in diabetic…
- Trial name
- NCT04106050
- Testing
- BIIB095, BIIB074, Lidocaine
- Volunteers
- healthy volunteers welcome
- Sponsor
- Biogen
Healthy Volunteers
A Study to Explore Pharmacodynamic Effects of BIIB104 on Brain Circuitry in Healthy Participants
The primary objective of the study is to explore the pharmacodynamic (PD) effects of BIIB104 on brain circuitry associated with emotional processing in healthy participants.
- Trial name
- NCT04068532
- Testing
- BIIB104
- Where
- United Kingdom
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy Volunteer
A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of BIIB091, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Healthy Adult Participants
This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of BIIB091 in healthy participants.This study will also determine the effect of food on the single oral…
- Trial name
- NCT03943056
- Testing
- BIIB091
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy
Safety, Tolerability and Pharmacokinetics of BIIB118 (PF-05251749)
This is a First in human (FIH) single ascending dose study to evaluate the safety, tolerability and pharmacokinetics (PKs) of BIIB118 following single oral doses in healthy human subjects
- Trial name
- NCT02443740
- Testing
- BIIB118
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy Adult Subjects, Healthy Elderly Subjects
Multiple Dose Study Of BIIB118 (PF-05251749) In Healthy Volunteers
This is the first clinical trial to evaluate ascending multiple oral doses in healthy adult and healthy elderly subjects to characterize the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BIIB118
- Trial name
- NCT02691702
- Testing
- BIIB118, Melatonin
- Where
- 2 sites in United States
- Volunteers
- 97 people, healthy volunteers welcome
- Sponsor
- Biogen
Frontotemporal Dementia, Behavioral Variant Frontotemporal Dementia
Cognitive, Behavioral, and Functional Change in Behavioral Variant Frontotemporal Dementia (bvFTD)
The objectives of the study are to; (1) estimate the change in disease -related cognitive decline over 1 year on a battery of cognitive tests administered to participants with early-stage symptomatic Behavioral Variant…
- Trial name
- FORWARD (NCT03088956)
- Testing
- Assessments
- Where
- 12 sites in United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Biogen
Alzheimer's Disease, Healthy Volunteer
Single-Ascending-Dose Study of BIIB076 in Healthy Volunteers and Participants With Alzheimer's Disease
The primary objective of the study is to evaluate the safety and tolerability of single-ascending intravenous (IV) infusions of BIIB076 in healthy volunteers and participants with Alzheimer's disease (AD).
- Trial name
- NCT03056729
- Testing
- BIIB076
- Where
- 8 sites in United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy
A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of PF-04958242 in Healthy Subjects
The purpose of the current study is to characterize the pharmacokinetic (PK) profile of PF 04958242 when co administered with a strong cytochrome P450 3A4 (CYP3A4) inhibitor.
- Trial name
- NCT02341482
- Testing
- PF-04958242, Itraconazole
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Biogen