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Completed

NCT Number: NCT04571424

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

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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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BIIB133 (Dapirolizumab pegol)

Drug

Administered as specified in the treatment arm

Other names: DZP

Placebo

Drug

Administered as specified in the treatment arm

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 1, 2020
Registry last updated
Apr 18, 2023

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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