Anaheim Clinical Trials
Anaheim, California, 92801, United States
NCT Number: NCT04571424
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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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Anaheim, California, 92801, United States
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
Other names: DZP
Administered as specified in the treatment arm
Time frame: Up to Day 120
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.
Time frame: Up to Day 120
Time frame: Up to Day 120
Time frame: Up to Day 120
Time frame: Up to Day 120
Time frame: Up to Day 120
Time frame: Up to Day 120
Time frame: Up to Day 120
Time frame: Up to Day 120
Time frame: Up to Day 120
Time frame: Up to Day 120
Time frame: Up to Day 120
Time frame: Up to Day 120
Time frame: Up to Day 120
Time frame: Up to Day 120
Time frame: Up to Day 120
Time frame: Up to Day 120
Time frame: Up to Day 120
Time frame: Up to Day 120
Time frame: Up to Day 120
Time frame: Up to Day 120
Time frame: Up to Day 120
Time frame: Up to Day 120
Time frame: Up to Day 120
Time frame: Up to Day 120
Time frame: Up to Day 120
Time frame: Up to Day 120
Time frame: Up to Day 120
Time frame: Up to Day 120
Time frame: Up to Day 120
Time frame: Up to Day 120
Time frame: Up to Day 120
Time frame: Up to Day 120
Time frame: Up to Day 120
Time frame: Up to Day 120
Time frame: Up to Day 120
Time frame: Up to Day 120
Biogen
Industry
Phase 1, Randomized, Blinded, Placebo-Controlled, Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Dapirolizumab Pegol (BIIB133) in Healthy Japanese and Caucasian Study 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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