A Study to Test the Safety and Tolerability and Pharmacokinetics of Single Doses of UCB0107 in Healthy Japanese Subjects

NCT ID: NCT03605082

Last Updated: 2019-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-25
• Study Completion Date: 2019-03-11

Brief Summary

The purpose of the study is to evaluate the safety and tolerability and serum Pharmacokinetics (PK) of single doses of UCB0107 administered in healthy Japanese subjects.

Conditions

Healthy Japanese Volunteers

Study Design

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

Study Groups

UCB0107

Subjects will be randomized to receive a predefined dosage of UCB0107 in order to maintain the blinding.

Group Type: EXPERIMENTAL

UCB0107

Intervention Type: DRUG

• Pharmaceutical form: solution for infusion
• Route of administration: intravenous use

Placebo

Subjects will be randomized and receive a placebo in order to maintain the blinding.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

• Pharmaceutical form: solution for infusion
• Route of administration: intravenous use

Interventions

UCB0107

• Pharmaceutical form: solution for infusion
• Route of administration: intravenous use

Intervention Type: DRUG

Placebo

• Pharmaceutical form: solution for infusion
• Route of administration: intravenous use

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Subject is male or female, >=20 and <=75 years of age
• Subject is of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage (a subject has all 4 Japanese grandparents born in Japan)
• Subject has a body mass index (BMI) >=18.0 and <=30.0 kg/m^2, with a body weight of at least 50 kilogram (kg) for males and 45 kg for females, and maximum 100 kg
• Subject is in good physical and mental health, in particular is not affected by any neurological disorder, in the opinion of the Investigator, as determined on the basis of medical history and a general clinical examination at Screening
• Subject has clinical laboratory test results within the reference ranges of the laboratory
• Subject has Blood pressure and pulse rate within normal range in supine position after 5 minutes rest
• Subject's electrocardiogram (ECG) is considered "normal," or "abnormal" but clinically nonsignificant (as interpreted by the Investigator)

Exclusion Criteria

• Subject has any clinically relevant abnormal findings in physical examination, laboratory tests, vital signs, or electrocardiogram, which, in the opinion of the Investigator, may place the subject at risk because of participation in the study
• Subject has a history of recurrent headaches, including migraine
• Subject has a history of alcohol and/or drug abuse up to 6 months before Screening
• Subject smokes on average >5 cigarettes/day (or equivalent) during the last 3 months and is not able to stop smoking during the In-Clinic Period
• Subject has any clinically relevant brain magnetic resonance imaging (MRI) abnormality at Screening
• Subject has >upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or total bilirubin (≥1.5xULN total bilirubin if known Gilbert's syndrome). If subject has elevations only in total bilirubin that are >ULN and <1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert's syndrome (ie, direct bilirubin <35%)
• Subject has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 2 years
• Subject has a positive serology test for hepatitis B surface antigen, hepatitis B core antibodies, hepatitis C virus antibodies or antibodies to human immunodeficiency virus (HIV) type 1 and/or type 2 at Screening
• Subject has a known hypersensitivity to any components of the investigational medicinal product (IMP), comparative drugs, any biologic or small molecule, or concomitant medication as stated in this protocol
• Female subject who is breastfeeding, pregnant, or plans to become pregnant during the study or within 6 months following the final dose of the IMP

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 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

Up0065 001

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

2018-000475-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

UP0065

Identifier Type: -

Identifier Source: org_study_id