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Healthy VolunteersPhase 1NCT04571424

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

A Phase 1 study testing BIIB133 (Dapirolizumab pegol) in people with Healthy Volunteers, run by Biogen at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
BIIB133 (Dapirolizumab pegol)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
33 participants
Where
1 siteUnited States
Study dates
14 Oct 2020to 8 Apr 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Anaheim Clinical Trials

    Anaheim, California, 92801

Other trials in United States

About this study

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

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.

Being tested
BIIB133 (Dapirolizumab pegol), Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BIIB133 (Dapirolizumab pegol)Drug

    Also called DZP

    Administered as specified in the treatment arm

  • PlaceboDrug

    Administered as specified in the treatment arm

Study groups in NCT04571424
Study groupRoleWhat they receive
Cohort 1: BIIB133 Dose 1ExperimentalParticipants will receive single IV infusion of BIIB133 Dose 1.
Receives: Drug: BIIB133 (Dapirolizumab pegol)
Cohort 2: BIIB133 Dose 2ExperimentalParticipants will receive single IV infusion of BIIB133 Dose 2.
Receives: Drug: BIIB133 (Dapirolizumab pegol)
Cohort 1-2: PlaceboPlacebo comparatorParticipants will receive single IV infusion of matching placebo to BIIB133.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to Day 120

Secondary outcomes (36)

  1. Plasma BIIB133 Concentration

    Measured: Up to Day 120

  2. Area under Concentration-Time Curve from Time 0 to Infinity (AUCinf) of BIIB133

    Measured: Up to Day 120

  3. Area under Concentration-Time Curve from Time 0 to Time t (AUC0-t) of BIIB133

    Measured: Up to Day 120

  4. Maximum Observed Concentration (Cmax) of BIIB133

    Measured: Up to Day 120

  5. Time to Reach Maximum Observed Concentration (Tmax) of BIIB133

    Measured: Up to Day 120

  6. Elimination Half-life (t½) of BIIB133

    Measured: Up to Day 120

  7. Clearance (CL) of BIIB133

    Measured: Up to Day 120

  8. Volume of Distribution (Vd) of BIIB133

    Measured: Up to Day 120

  9. Percentage of AUCinf Obtained by Extrapolation (AUCextr%) of BIIB133

    Measured: Up to Day 120

  10. Area under Concentration-Time Curve from Time 0 to Infinity Normalized by Dose (AUCinf/Dose) of BIIB133

    Measured: Up to Day 120

  11. Area under Concentration-Time Curve from Time 0 to Time t Normalized by Dose (AUC0-t/Dose) of BIIB133

    Measured: Up to Day 120

  12. Maximum Observed Concentration Normalized by Dose (Cmax/Dose) of BIIB133

    Measured: Up to Day 120

  13. Plasma Polyethylene Glycol (PEG) Concentration

    Measured: Up to Day 120

  14. AUCinf of PEG

    Measured: Up to Day 120

  15. AUC0-t of PEG

    Measured: Up to Day 120

  16. Cmax of PEG

    Measured: Up to Day 120

  17. Tmax of PEG

    Measured: Up to Day 120

  18. t½ of PEG

    Measured: Up to Day 120

  19. AUCextr% of PEG

    Measured: Up to Day 120

  20. AUCinf/Dose of PEG

    Measured: Up to Day 120

  21. AUC0-t/Dose of PEG

    Measured: Up to Day 120

  22. Cmax/Dose of PEG

    Measured: Up to Day 120

  23. Urine PEG Concentration

    Measured: Up to Day 120

  24. Ratio of AUCinf of BIIB133 between Japanese and Caucasian Participants

    Measured: Up to Day 120

  25. Ratio of AUC0-t of BIIB133 between Japanese and Caucasian Participants

    Measured: Up to Day 120

  26. Ratio of Cmax of BIIB133 between Japanese and Caucasian Participants

    Measured: Up to Day 120

  27. Ratio of t½ of BIIB133 between Japanese and Caucasian Participants

    Measured: Up to Day 120

  28. Ratio of CL of BIIB133 between Japanese and Caucasian Participants

    Measured: Up to Day 120

  29. Ratio of Vd of BIIB133 between Japanese and Caucasian Participants

    Measured: Up to Day 120

  30. Ratio of AUCinf/Dose of BIIB133 between Japanese and Caucasian Participants

    Measured: Up to Day 120

  31. Ratio of AUC0-t/Dose of BIIB133 between Japanese and Caucasian Participants

    Measured: Up to Day 120

  32. Ratio of Cmax/Dose of BIIB133 between Japanese and Caucasian Participants

    Measured: Up to Day 120

  33. Number of Participants with Anti-BIIB133 Antibodies

    Measured: Up to Day 120

  34. Plasma Concentration of Anti-BIIB133 Antibodies

    Measured: Up to Day 120

  35. Number of Participants with Anti-PEG Antibodies

    Measured: Up to Day 120

  36. Plasma Concentration of Anti-PEG Antibodies

    Measured: Up to Day 120

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2020
  2. Study start14 Oct 2020
  3. Primary completion8 Apr 2021
  4. Study completion8 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04571424
Sponsor's protocol ID
253HV101
Status last verified
Apr 2023
First submitted
25 Sep 2020
Last updated
18 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BIIB133 (Dapirolizumab pegol) in people with Healthy Volunteers, run by Biogen at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Up to Day 120). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04571424.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.

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