Clinical trial NCT03605082: A Study to Test the Safety and Tolerability and Pharmacokinetics of Single Doses of UCB0107 in Healthy Japanese Subjects
Official title: A Single-center, Investigator-blind, Subject Blind, Randomized, Placebo-controlled Study to Evaluate Safety and Tolerability and Pharmacokinetics of Single Doses of UCB0107 in Healthy Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Japanese Volunteers
Keywords: UCB0107
Phase 1
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2018-07-30
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: The incidence of treatment-emergent adverse events during the study from first dose of UCB0107 to safety follow-up/withdraw
timeFrame: From first dose of UCB0107 to safety follow-up/withdraw on day 140 +/-4 days
measure: Maximum observed serum concentration of UCB0107 during the study
timeFrame: The blood sampling time points for serum Pharmacokinetics will be as follows: predose (<=60 minutes before dosing); end of infusion, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose; and on Day 7, 14, 28, 42, 56, 84 and 140
measure: Area under the concentration-time curve from time 0 to infinity of UCB0107 during the study
timeFrame: The blood samples for serum Pharmacokinetics will be taken from predose to Day 140
measure: Area under the concentration-time curve from time 0 to time t of UCB0107 during the study
timeFrame: The blood sampling time points for serum Pharmacokinetics will be as follows: predose (<=60 minutes before dosing); end of infusion, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose; and on Day 7, 14, 28, 42, 56, 84 and 140
measure: Terminal half-life of UCB0107 during the study
timeFrame: The blood sampling time points for serum Pharmacokinetics will be as follows: predose (<=60 minutes before dosing); end of infusion, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose; and on Day 7, 14, 28, 42, 56, 84 and 140
measure: Volume of distribution of UCB0107 during the study
timeFrame: The blood sampling time points for serum Pharmacokinetics will be as follows: predose (<=60 minutes before dosing); end of infusion, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose; and on Day 7, 14, 28, 42, 56, 84 and 140
measure: The clearance of UCB0107 during the study
timeFrame: The blood sampling time points for serum Pharmacokinetics will be as follows: predose (<=60 minutes before dosing); end of infusion, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose; and on Day 7, 14, 28, 42, 56, 84 and 140
measure: The time to maximum observed serum concentration of UCB0107 during the study
timeFrame: The blood sampling time points for serum Pharmacokinetics will be as follows: predose (<=60 minutes before dosing); end of infusion, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose; and on Day 7, 14, 28, 42, 56, 84 and 140
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Up0065 001
Study officials:
affiliation: 001 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References: