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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04571424
• Other study ID #: 253HV101
• Status: Completed
• Phase: Phase 1
• Start date: October 14, 2020
• Est. completion date: April 8, 2021

Study information

• Verified date: April 2023
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: April 8, 2021
• Est. primary completion date: April 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• BIIB133 (Dapirolizumab pegol)
Administered as specified in the treatment arm
• Placebo
Administered as specified in the treatment arm

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials	Anaheim	California

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Plasma BIIB133 Concentration		Up to Day 120
Secondary	Area under Concentration-Time Curve from Time 0 to Infinity (AUCinf) of BIIB133		Up to Day 120
Secondary	Area under Concentration-Time Curve from Time 0 to Time t (AUC0-t) of BIIB133		Up to Day 120
Secondary	Maximum Observed Concentration (Cmax) of BIIB133		Up to Day 120
Secondary	Time to Reach Maximum Observed Concentration (Tmax) of BIIB133		Up to Day 120
Secondary	Elimination Half-life (t½) of BIIB133		Up to Day 120
Secondary	Clearance (CL) of BIIB133		Up to Day 120
Secondary	Volume of Distribution (Vd) of BIIB133		Up to Day 120
Secondary	Percentage of AUCinf Obtained by Extrapolation (AUCextr%) of BIIB133		Up to Day 120
Secondary	Area under Concentration-Time Curve from Time 0 to Infinity Normalized by Dose (AUCinf/Dose) of BIIB133		Up to Day 120
Secondary	Area under Concentration-Time Curve from Time 0 to Time t Normalized by Dose (AUC0-t/Dose) of BIIB133		Up to Day 120
Secondary	Maximum Observed Concentration Normalized by Dose (Cmax/Dose) of BIIB133		Up to Day 120
Secondary	Plasma Polyethylene Glycol (PEG) Concentration		Up to Day 120
Secondary	AUCinf of PEG		Up to Day 120
Secondary	AUC0-t of PEG		Up to Day 120
Secondary	Cmax of PEG		Up to Day 120
Secondary	Tmax of PEG		Up to Day 120
Secondary	t½ of PEG		Up to Day 120
Secondary	AUCextr% of PEG		Up to Day 120
Secondary	AUCinf/Dose of PEG		Up to Day 120
Secondary	AUC0-t/Dose of PEG		Up to Day 120
Secondary	Cmax/Dose of PEG		Up to Day 120
Secondary	Urine PEG Concentration		Up to Day 120
Secondary	Ratio of AUCinf of BIIB133 between Japanese and Caucasian Participants		Up to Day 120
Secondary	Ratio of AUC0-t of BIIB133 between Japanese and Caucasian Participants		Up to Day 120
Secondary	Ratio of Cmax of BIIB133 between Japanese and Caucasian Participants		Up to Day 120
Secondary	Ratio of t½ of BIIB133 between Japanese and Caucasian Participants		Up to Day 120
Secondary	Ratio of CL of BIIB133 between Japanese and Caucasian Participants		Up to Day 120
Secondary	Ratio of Vd of BIIB133 between Japanese and Caucasian Participants		Up to Day 120
Secondary	Ratio of AUCinf/Dose of BIIB133 between Japanese and Caucasian Participants		Up to Day 120
Secondary	Ratio of AUC0-t/Dose of BIIB133 between Japanese and Caucasian Participants		Up to Day 120
Secondary	Ratio of Cmax/Dose of BIIB133 between Japanese and Caucasian Participants		Up to Day 120
Secondary	Number of Participants with Anti-BIIB133 Antibodies		Up to Day 120
Secondary	Plasma Concentration of Anti-BIIB133 Antibodies		Up to Day 120
Secondary	Number of Participants with Anti-PEG Antibodies		Up to Day 120
Secondary	Plasma Concentration of Anti-PEG Antibodies		Up to Day 120