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Trial record 3 of 3 for:    Dapirolizumab Pegol

A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB133 (Dapirolizumab Pegol) in Healthy Japanese and Caucasian Participants

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ClinicalTrials.gov Identifier: NCT04571424
Recruitment Status : Completed
First Posted : October 1, 2020
Last Update Posted : April 30, 2021
Sponsor:
Information provided by (Responsible Party):
Biogen

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: BIIB133 (Dapirolizumab pegol) Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 14, 2020
Actual Primary Completion Date : April 8, 2021
Actual Study Completion Date : April 8, 2021

Arm Intervention/treatment
Experimental: Cohort 1: BIIB133 Dose 1
Participants will receive single IV infusion of BIIB133 Dose 1.
Drug: BIIB133 (Dapirolizumab pegol)
Administered as specified in the treatment arm
Other Name: DZP

Experimental: Cohort 2: BIIB133 Dose 2
Participants will receive single IV infusion of BIIB133 Dose 2.
Drug: BIIB133 (Dapirolizumab pegol)
Administered as specified in the treatment arm
Other Name: DZP

Placebo Comparator: Cohort 1-2: Placebo
Participants will receive single IV infusion of matching placebo to BIIB133.
Drug: Placebo
Administered as specified in the treatment arm




Primary Outcome Measures :
  1. Number of Participants with Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ 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.


Secondary Outcome Measures :
  1. Plasma BIIB133 Concentration [ Time Frame: Up to Day 120 ]
  2. Area under Concentration-Time Curve from Time 0 to Infinity (AUCinf) of BIIB133 [ Time Frame: Up to Day 120 ]
  3. Area under Concentration-Time Curve from Time 0 to Time t (AUC0-t) of BIIB133 [ Time Frame: Up to Day 120 ]
  4. Maximum Observed Concentration (Cmax) of BIIB133 [ Time Frame: Up to Day 120 ]
  5. Time to Reach Maximum Observed Concentration (Tmax) of BIIB133 [ Time Frame: Up to Day 120 ]
  6. Elimination Half-life (t½) of BIIB133 [ Time Frame: Up to Day 120 ]
  7. Clearance (CL) of BIIB133 [ Time Frame: Up to Day 120 ]
  8. Volume of Distribution (Vd) of BIIB133 [ Time Frame: Up to Day 120 ]
  9. Percentage of AUCinf Obtained by Extrapolation (AUCextr%) of BIIB133 [ Time Frame: Up to Day 120 ]
  10. Area under Concentration-Time Curve from Time 0 to Infinity Normalized by Dose (AUCinf/Dose) of BIIB133 [ Time Frame: Up to Day 120 ]
  11. Area under Concentration-Time Curve from Time 0 to Time t Normalized by Dose (AUC0-t/Dose) of BIIB133 [ Time Frame: Up to Day 120 ]
  12. Maximum Observed Concentration Normalized by Dose (Cmax/Dose) of BIIB133 [ Time Frame: Up to Day 120 ]
  13. Plasma Polyethylene Glycol (PEG) Concentration [ Time Frame: Up to Day 120 ]
  14. AUCinf of PEG [ Time Frame: Up to Day 120 ]
  15. AUC0-t of PEG [ Time Frame: Up to Day 120 ]
  16. Cmax of PEG [ Time Frame: Up to Day 120 ]
  17. Tmax of PEG [ Time Frame: Up to Day 120 ]
  18. t½ of PEG [ Time Frame: Up to Day 120 ]
  19. AUCextr% of PEG [ Time Frame: Up to Day 120 ]
  20. AUCinf/Dose of PEG [ Time Frame: Up to Day 120 ]
  21. AUC0-t/Dose of PEG [ Time Frame: Up to Day 120 ]
  22. Cmax/Dose of PEG [ Time Frame: Up to Day 120 ]
  23. Urine PEG Concentration [ Time Frame: Up to Day 120 ]
  24. Ratio of AUCinf of BIIB133 between Japanese and Caucasian Participants [ Time Frame: Up to Day 120 ]
  25. Ratio of AUC0-t of BIIB133 between Japanese and Caucasian Participants [ Time Frame: Up to Day 120 ]
  26. Ratio of Cmax of BIIB133 between Japanese and Caucasian Participants [ Time Frame: Up to Day 120 ]
  27. Ratio of t½ of BIIB133 between Japanese and Caucasian Participants [ Time Frame: Up to Day 120 ]
  28. Ratio of CL of BIIB133 between Japanese and Caucasian Participants [ Time Frame: Up to Day 120 ]
  29. Ratio of Vd of BIIB133 between Japanese and Caucasian Participants [ Time Frame: Up to Day 120 ]
  30. Ratio of AUCinf/Dose of BIIB133 between Japanese and Caucasian Participants [ Time Frame: Up to Day 120 ]
  31. Ratio of AUC0-t/Dose of BIIB133 between Japanese and Caucasian Participants [ Time Frame: Up to Day 120 ]
  32. Ratio of Cmax/Dose of BIIB133 between Japanese and Caucasian Participants [ Time Frame: Up to Day 120 ]
  33. Number of Participants with Anti-BIIB133 Antibodies [ Time Frame: Up to Day 120 ]
  34. Plasma Concentration of Anti-BIIB133 Antibodies [ Time Frame: Up to Day 120 ]
  35. Number of Participants with Anti-PEG Antibodies [ Time Frame: Up to Day 120 ]
  36. Plasma Concentration of Anti-PEG Antibodies [ Time Frame: Up to Day 120 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  • Negative polymerase chain reaction (PCR) test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) within 14 days of Day -1 (inclusive).
  • Japanese study participant has both biological parents and all 4 grandparents of Japanese descent and, if living outside of Japan for more than 5 years, must maintain a Japanese diet.
  • Caucasian study participant has both biological parents and all 4 grandparents of Caucasian descent.
  • Have a body weight between 50 and 90 kilograms (kg) (inclusive) and body mass index (BMI) between 18.0 and 26.0 kilograms per meter square (kg/m^2) (inclusive) at the Screening Visit.

Key Exclusion Criteria:

  • History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
  • Have undergone major surgery in the last 6 months or plans to undergo elective major surgery during the study period.
  • Have a known hypersensitivity to any components or excipients of DZP including polyethylene glycol (PEG).
  • Have received any prescription or nonprescription medicines including over-the-counter remedies and herbal and dietary supplements within 14 days or 5 half-lives of the respective drug, whichever is longer, other than acetaminophen and antihistamines.
  • Current enrollment in any other drug, biological, device, or clinical study, or treatment with an investigational drug or approved therapy for investigational use within 30 days prior to Day -1, or 5 half-lives, whichever is longer.
  • History of chronic, recurrent, or recent (within 6 months prior to Screening) severe infection and/or at risk for severe infection, as determined by the Investigator.
  • Have symptoms consistent with SARS-CoV-2 infection, per the judgement of the Investigator, within 14 days prior to Day -1, including but not limited to fever (temperature > 37.5 degree Celsius [°C]), sore throat, new and persistent cough, breathlessness, or loss of taste or smell.
  • Have close contact within 14 days prior to Day -1 with a SARS-CoV-2 (+) individual. Close contact is defined as (1) being within 6 feet of an infected individual (as confirmed via laboratory assessment) for at least 15 minutes within 2 days of symptom onset or (2) being within 6 feet of an asymptomatic infected individual for at least 15 minutes within 2 days of that asymptomatic individual undergoing specimen collection for SARS-CoV-2 testing.
  • Clinically significant abnormal laboratory test result values, as determined by the Investigator, at Screening or Day -1.
  • Have received any live/attenuated vaccination within 6 weeks prior to Visit 2 (Day 1) or plans to receive any live/attenuated vaccination within 120 days after the dose of study treatment.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04571424


Locations
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United States, California
Anaheim Clinical Trials
Anaheim, California, United States, 92801
Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen
Principal Investigator: Amina Haggag, M.D Anaheim Clinical Trials
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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT04571424    
Other Study ID Numbers: 253HV101
First Posted: October 1, 2020    Key Record Dates
Last Update Posted: April 30, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No