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The primary objective of the study is to assess the safety and tolerability of a single intravenous (IV) dose of dapirolizumab pegol (DZP) in Japanese healthy study participants compared with those of Caucasian healthy study participants.
The secondary objectives of the study are to assess the pharmacokinetic(s) (PK) of a single IV dose of DZP in Japanese and Caucasian healthy study participants, to evaluate ethnic sensitivity on the PK of DZP between body weight- and gender-matched Japanese and Caucasian healthy study participants and to evaluate the immunogenicity of a single IV dose of DZP in Japanese and Caucasian healthy study participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: BIIB133 Dose 1 | Experimental | Participants will receive single IV infusion of BIIB133 Dose 1. |
|
| Cohort 2: BIIB133 Dose 2 | Experimental | Participants will receive single IV infusion of BIIB133 Dose 2. |
|
| Cohort 1-2: Placebo | Placebo Comparator | Participants will receive single IV infusion of matching placebo to BIIB133. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB133 (Dapirolizumab pegol) | Drug | Administered as specified in the treatment arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a 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, 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 birth defect. | Up to Day 120 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma BIIB133 Concentration | Up to Day 120 | |
| Area under Concentration-Time Curve from Time 0 to Infinity (AUCinf) of BIIB133 | Up to Day 120 | |
| Area under Concentration-Time Curve from Time 0 to Time t (AUC0-t) of BIIB133 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Amina Haggag, M.D | Anaheim Clinical Trials | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials | Anaheim | California | 92801 | United States |
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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| Placebo | Drug | Administered as specified in the treatment arm |
|
| Up to Day 120 |
| Maximum Observed Concentration (Cmax) of BIIB133 | Up to Day 120 |
| Time to Reach Maximum Observed Concentration (Tmax) of BIIB133 | Up to Day 120 |
| Elimination Half-life (t½) of BIIB133 | Up to Day 120 |
| Clearance (CL) of BIIB133 | Up to Day 120 |
| Volume of Distribution (Vd) of BIIB133 | Up to Day 120 |
| Percentage of AUCinf Obtained by Extrapolation (AUCextr%) of BIIB133 | Up to Day 120 |
| Area under Concentration-Time Curve from Time 0 to Infinity Normalized by Dose (AUCinf/Dose) of BIIB133 | Up to Day 120 |
| Area under Concentration-Time Curve from Time 0 to Time t Normalized by Dose (AUC0-t/Dose) of BIIB133 | Up to Day 120 |
| Maximum Observed Concentration Normalized by Dose (Cmax/Dose) of BIIB133 | Up to Day 120 |
| Plasma Polyethylene Glycol (PEG) Concentration | Up to Day 120 |
| AUCinf of PEG | Up to Day 120 |
| AUC0-t of PEG | Up to Day 120 |
| Cmax of PEG | Up to Day 120 |
| Tmax of PEG | Up to Day 120 |
| t½ of PEG | Up to Day 120 |
| AUCextr% of PEG | Up to Day 120 |
| AUCinf/Dose of PEG | Up to Day 120 |
| AUC0-t/Dose of PEG | Up to Day 120 |
| Cmax/Dose of PEG | Up to Day 120 |
| Urine PEG Concentration | Up to Day 120 |
| Ratio of AUCinf of BIIB133 between Japanese and Caucasian Participants | Up to Day 120 |
| Ratio of AUC0-t of BIIB133 between Japanese and Caucasian Participants | Up to Day 120 |
| Ratio of Cmax of BIIB133 between Japanese and Caucasian Participants | Up to Day 120 |
| Ratio of t½ of BIIB133 between Japanese and Caucasian Participants | Up to Day 120 |
| Ratio of CL of BIIB133 between Japanese and Caucasian Participants | Up to Day 120 |
| Ratio of Vd of BIIB133 between Japanese and Caucasian Participants | Up to Day 120 |
| Ratio of AUCinf/Dose of BIIB133 between Japanese and Caucasian Participants | Up to Day 120 |
| Ratio of AUC0-t/Dose of BIIB133 between Japanese and Caucasian Participants | Up to Day 120 |
| Ratio of Cmax/Dose of BIIB133 between Japanese and Caucasian Participants | Up to Day 120 |
| Number of Participants with Anti-BIIB133 Antibodies | Up to Day 120 |
| Plasma Concentration of Anti-BIIB133 Antibodies | Up to Day 120 |
| Number of Participants with Anti-PEG Antibodies | Up to Day 120 |
| Plasma Concentration of Anti-PEG Antibodies | Up to Day 120 |
| ID | Term |
|---|---|
| C000607972 | dapirolizumab pegol |
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