A Study to Evaluate Safety and Tolerability of Single Ascending Doses of Rozanolixizumab Administered by Subcutaneous Infusion in Healthy Japanese, Chinese and Caucasian Study Participants

A Randomized, Participant-Blind, Investigator-Blind, Placebo-Controlled Study Comparing Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Subcutaneous Doses of Rozanolixizumab in Japanese, Chinese and Caucasian Healthy-Volunteer Study Participants

The purpose of the study is to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of rozanolixizumab in japanese, chinese and caucasian healthy-volunteer study participants.

Study Overview

• Status: Completed
• Conditions: Healthy-volunteers
• Intervention / Treatment: Drug: Rozanolixizumab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • UP0060 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Study participant must be 18 to 65 years of age, inclusive, at the time of signing the Informed Consent form (ICF)
• Study participants who are overtly healthy in the opinion of the investigator as determined by medical history and a general clinical examination, including physical examination, laboratory tests, and cardiac monitoring
• Study participant must be considered reliable and capable of adhering to the protocol, according to the judgment of the investigator, and is able to communicate satisfactorily with the investigator and comply with all clinical study requirements
• Japanese or Chinese study participant is of Japanese or Chinese descent, determined by verbal confirmation of familial heritage with all 4 grandparents of Japanese or Chinese descent
• Caucasian study participant is of Caucasian descent as evidenced in appearance and verbal confirmation of familial heritage with all 4 grandparents of Caucasian descent
• Study participant is of normal weight as determined by a body mass index (BMI) between 18 and 32 kg/m2, inclusive, with a body weight of at least 50 kg (male) or 45 kg (female) and no greater than 100 kg

Exclusion Criteria:

• Any medical (acute or chronic illness) or psychiatric condition that, in the opinion of the investigator, could harm the study participant or would compromise the study participant's ability to participate in this study.
• History of known inflammatory bowel disease, active diverticular disease, or a history of confirmed duodenal, gastric, or esophageal ulceration in the previous 6 months
• Significant allergies to humanized monoclonal antibodies
• Known hypersensitivity to any components of the investigational medicinal product (IMP)
• Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe posttreatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A [IgA] dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis)
• Current or chronic history of liver disease, or known hepatic or biliary abnormalities
• Study participant is splenectomized, or has a clinically relevant active infection (eg, sepsis, pneumonia, abscess) or has had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to study treatment
• Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing
• Received a vaccination within 8 weeks prior to Day -1; or intends to have a vaccination during the course of the study. Prior/Concurrent clinical study experience
• Exposure to more than 3 new chemical entities within 12 months prior to dosing
• Previously participated in this clinical study or has previously been assigned to treatment in a clinical study of IMP under investigation in this clinical study
• Participated in another study of an IMP (or a medical device) within the previous 90 days or 5 half-lives prior to Day -1 (whichever is longer) or is currently participating in another study of an IMP (or a medical device)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

11

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Dose 1 of rozanolixizumab in Japanese subjects; Japanese subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding.	Drug: Rozanolixizumab; Pharmaceutical form: solution for injection; Route of administration: subcutaneous infusion
EXPERIMENTAL: Dose 2 of rozanolixizumab in Japanese subjects; Japanese subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding.	Drug: Rozanolixizumab; Pharmaceutical form: solution for injection; Route of administration: subcutaneous infusion
EXPERIMENTAL: Dose 3 of rozanolixizumab in Japanese subjects; Japanese subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding.	Drug: Rozanolixizumab; Pharmaceutical form: solution for injection; Route of administration: subcutaneous infusion
EXPERIMENTAL: Dose 1 of rozanolixizumab in Caucasian subjects; Caucasian subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding.	Drug: Rozanolixizumab; Pharmaceutical form: solution for injection; Route of administration: subcutaneous infusion
EXPERIMENTAL: Dose 2 of rozanolixizumab in Caucasian subjects; Caucasian subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding.	Drug: Rozanolixizumab; Pharmaceutical form: solution for injection; Route of administration: subcutaneous infusion
EXPERIMENTAL: Dose 3 of rozanolixizumab in Caucasian subjects; Caucasian subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding.	Drug: Rozanolixizumab; Pharmaceutical form: solution for injection; Route of administration: subcutaneous infusion
EXPERIMENTAL: Dose 2 of rozanolixizumab in Chinese subjects; Chinese subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding.	Drug: Rozanolixizumab; Pharmaceutical form: solution for injection; Route of administration: subcutaneous infusion
EXPERIMENTAL: Dose 3 of rozanolixizumab in Chinese subjects; Chinese subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding.	Drug: Rozanolixizumab; Pharmaceutical form: solution for injection; Route of administration: subcutaneous infusion
PLACEBO_COMPARATOR: Placebo in Japanese subjects; Japanese subjects will be randomized to receive a predefined dosage of placebo in order to maintain the blinding.	Drug: Placebo; Pharmaceutical form: solution for injection; Route of administration: subcutaneous infusion
PLACEBO_COMPARATOR: Placebo in Chinese subjects; Chinese subjects will be randomized to receive a predefined dosage of placebo in order to maintain the blinding.	Drug: Placebo; Pharmaceutical form: solution for injection; Route of administration: subcutaneous infusion
PLACEBO_COMPARATOR: Placebo in Caucasian subjects; Caucasian subjects will be randomized to receive a predefined dosage of placebo in order to maintain the blinding.	Drug: Placebo; Pharmaceutical form: solution for injection; Route of administration: subcutaneous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment-emergent adverse events (TEAEs) from Baseline to Safety Follow-up (SFU) in healthy Japanese study participants	An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could 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.	From Baseline until Safety Follow-up (up to Week 8)
Treatment-emergent adverse events (TEAEs) from Baseline to Safety Follow-up (SFU) in healthy Chinese study participants	An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could 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.	From Baseline until Safety Follow-up (up to Week 8)
Maximum observed plasma concentration (Cmax) of rozanolixizumab in healthy Japanese study participants	Maximum observed plasma concentration (Cmax)	Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours
Maximum observed plasma concentration (Cmax) of rozanolixizumab in healthy Chinese study participants	Maximum observed plasma concentration (Cmax)	Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours
Time to maximum observed plasma concentration (tmax) of rozanolixizumab in healthy Japanese study participants	Time of observed Cmax (tmax)	Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours
Time to maximum observed plasma concentration (tmax) of rozanolixizumab in healthy Chinese study participants	Time of observed Cmax (tmax)	Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours
Area under the concentration-time curve from time 0 to time t (AUC(0-t)) of rozanolixizumab in healthy Japanese study participants	AUC(0-t): Area under the curve from time 0 to time t, the time of last quantifiable concentration	Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours
Area under the concentration-time curve from time 0 to time t (AUC(0-t)) of rozanolixizumab in healthy Chinese study participants	AUC(0-t): Area under the curve from time 0 to time t, the time of last quantifiable concentration	Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment-emergent adverse events (TEAEs) from Baseline to Safety Follow-up (SFU) in healthy Caucasian	An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could 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.	From Baseline until Safety Follow-up (up to Week 8)
AUC(0-t)/BW: Body weight normalized AUC(0-t) of rozanolixizumab	AUC(0-t)/BW: Body weight normalized AUC(0-t) of rozanolixizumab in healthy Japanese, Chinese and Caucasian study participants	Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours
AUC(0-t)/D: Dose normalized AUC(0-t)	AUC(0-t)/D: Dose normalized AUC(0-t) of rozanolixizumab in healthy Japanese, Chinese and Caucasian study participants	Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours
AUC(0-t)/D/BW: Dose and body weight normalized AUC(0-t)	AUC(0-t)/D/BW: Dose and body weight normalized AUC(0-t) of rozanolixizumab in healthy Japanese, Chinese and Caucasian study participants	Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours
Cmax/BW: Body weight normalized Cmax of rozanolixizumab	Cmax/BW: Body weight normalized Cmax of rozanolixizumab in healthy Japanese, Chinese and Caucasian study participants	Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours
Cmax/D: Dose normalized Cmax	Cmax/D: Dose normalized Cmax of rozanolixizumab in healthy Japanese, Chinese and Caucasian study participants	Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours
Cmax/D/BW: Dose and body weight normalized Cmax	Cmax/D/BW: Dose and body weight normalized Cmax of rozanolixizumab in healthy Japanese, Chinese and Caucasian study participants	Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours

Collaborators and Investigators

• Sponsor: UCB Biopharma S.P.R.L.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 18, 2019
• Primary Completion (ACTUAL): April 28, 2020
• Study Completion (ACTUAL): April 28, 2020

Study Registration Dates

• First Submitted: February 28, 2019
• First Submitted That Met QC Criteria: February 28, 2019
• First Posted (ACTUAL): March 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 15, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Phase 1; Rozanolixizumab; UCB7665; Caucasian healthy-volunteers; Japanese healthy-volunteers; Chinese healthy-volunteers
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Rozanolixizumab
• Other Study ID Numbers: UP0060; 2018-004485-34 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No