BIIB107
DrugAdministered as specified in the treatment arm.
NCT Number: NCT04593121
The primary objective is to determine the safety and tolerability of single and multiple ascending subcutaneous (SC) doses and a single intravenous (IV) dose of BIIB107 in healthy adult participants. The secondary objectives are to characterize the single-dose pharmacokinetic (PK) of SC and IV BIIB107 in healthy adult participants and to characterize the multiple-dose PK of SC BIIB107 in healthy adult participants.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
CenExel Anaheim Clinical Trials, Anaheim, California, United States
BIIB107 is a monoclonal antibody (mAb) that targets alpha-4 integrins and is currently in development for people with multiple sclerosis.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Administered as specified in the treatment arm.
Administered as specified in the treatment arm.
Time frame: Day -1 up to Day 84
An AE is any untoward medical occurrence in a patient 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, places the participant at immediate risk of death, 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.
Time frame: Day -1 up to Day 169
An AE is any untoward medical occurrence in a patient 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, places the participant at immediate risk of death, 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.
Time frame: Day 1 pre-dose and multiple time-points up to Day 84
Time frame: Day 1 pre-dose and multiple time-points up to Day 84
Time frame: Day 1 pre-dose and multiple time-points up to Day 84
Time frame: Day 1 pre-dose and multiple time-points up to Day 84
Time frame: Day 1 pre-dose and multiple time-points up to Day 84
Time frame: Day 1 pre-dose and multiple time-points up to Day 84
Time frame: Day 1 pre-dose and multiple time-points up to Day 84
Time frame: Day 1 pre-dose and multiple time-points up to Day 84
Time frame: Day 1 pre-dose and multiple time-points up to Day 84
Time frame: Day 1 pre-dose and multiple time-points up to Day 84
Time frame: Day 1 pre-dose and multiple time-points up to Day 169
Time frame: Day 1 pre-dose and multiple time-points up to Day 169
Time frame: Day 1 pre-dose and multiple time-points up to Day 169
Time frame: Day 1 pre-dose and multiple time-points up to Day 169
Time frame: Day 1 pre-dose and multiple time-points up to Day 169
Time frame: Day 1 pre-dose and multiple time-points up to Day 169
Time frame: Day 1 pre-dose and multiple time-points up to Day 169
Time frame: Day 1 pre-dose and multiple time-points up to Day 169
Biogen
Industry
A Phase 1, Randomized, Blinded, Placebo-Controlled, Single- and Multiple-Ascending-Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB107 in Healthy Adult Participants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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