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

NCT ID: NCT03859219

Last Updated: 2021-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-18
• Study Completion Date: 2020-04-28

Brief Summary

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.

Conditions

Healthy-volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Rozanolixizumab

Intervention Type: DRUG

• Pharmaceutical form: solution for injection
• Route of administration: subcutaneous infusion

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.

Group Type: EXPERIMENTAL

Rozanolixizumab

Intervention Type: DRUG

• Pharmaceutical form: solution for injection
• Route of administration: subcutaneous infusion

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.

Group Type: EXPERIMENTAL

Rozanolixizumab

Intervention Type: DRUG

• Pharmaceutical form: solution for injection
• Route of administration: subcutaneous infusion

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.

Group Type: EXPERIMENTAL

Rozanolixizumab

Intervention Type: DRUG

• Pharmaceutical form: solution for injection
• Route of administration: subcutaneous infusion

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.

Group Type: EXPERIMENTAL

Rozanolixizumab

Intervention Type: DRUG

• Pharmaceutical form: solution for injection
• Route of administration: subcutaneous infusion

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.

Group Type: EXPERIMENTAL

Rozanolixizumab

Intervention Type: DRUG

• Pharmaceutical form: solution for injection
• Route of administration: subcutaneous infusion

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.

Group Type: EXPERIMENTAL

Rozanolixizumab

Intervention Type: DRUG

• Pharmaceutical form: solution for injection
• Route of administration: subcutaneous infusion

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.

Group Type: EXPERIMENTAL

Rozanolixizumab

Intervention Type: DRUG

• Pharmaceutical form: solution for injection
• Route of administration: subcutaneous infusion

Placebo in Japanese subjects

Japanese subjects will be randomized to receive a predefined dosage of placebo in order to maintain the blinding.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

• Pharmaceutical form: solution for injection
• Route of administration: subcutaneous infusion

Placebo in Chinese subjects

Chinese subjects will be randomized to receive a predefined dosage of placebo in order to maintain the blinding.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

• Pharmaceutical form: solution for injection
• Route of administration: subcutaneous infusion

Placebo in Caucasian subjects

Caucasian subjects will be randomized to receive a predefined dosage of placebo in order to maintain the blinding.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

• Pharmaceutical form: solution for injection
• Route of administration: subcutaneous infusion

Interventions

Rozanolixizumab

• Pharmaceutical form: solution for injection
• Route of administration: subcutaneous infusion

Intervention Type: DRUG

Placebo

• Pharmaceutical form: solution for injection
• Route of administration: subcutaneous infusion

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

UCB Biopharma S.P.R.L.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Cares

Role: STUDY_DIRECTOR

001 844 599 2273 (UCB)

Locations

UP0060 1

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

2018-004485-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

UP0060

Identifier Type: -

Identifier Source: org_study_id