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

Healthy Japanese Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03605082
• Other study ID #: UP0065
• Secondary ID: 2018-000475-32
• Status: Completed
• Phase: Phase 1
• Start date: July 25, 2018
• Est. completion date: March 11, 2019

Study information

• Verified date: March 2019
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 11, 2019
• Est. primary completion date: March 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Japanese Volunteers

Intervention

Drug:
• UCB0107
Pharmaceutical form: solution for infusion Route of administration: intravenous use

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

Locations

Country	Name	City	State
United Kingdom	Up0065 001	London

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma S.P.R.L.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of treatment-emergent adverse events during the study from first dose of UCB0107 to safety follow-up/withdraw	An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.	From first dose of UCB0107 to safety follow-up/withdraw on day 140 +/-4 days
Primary	Maximum observed serum concentration of UCB0107 during the study	Pharmacokinetic variable: Cmax: maximum observed serum concentration	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
Primary	Area under the concentration-time curve from time 0 to infinity of UCB0107 during the study	Pharmacokinetic variable: AUC: area under the concentration-time curve from time 0 to infinity	The blood samples for serum Pharmacokinetics will be taken from predose to Day 140
Primary	Area under the concentration-time curve from time 0 to time t of UCB0107 during the study	Pharmacokinetic variable: AUC(0-t): area under the concentration-time curve from time 0 to time t, the time of the last quantifiable concentration	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
Primary	Terminal half-life of UCB0107 during the study	Pharmacokinetic variable: t1/2: terminal half-life	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
Primary	Volume of distribution of UCB0107 during the study	Pharmacokinetic variable: Vz: volume of distribution	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
Primary	The clearance of UCB0107 during the study	Pharmacokinetic variable: CL: clearance	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
Primary	The time to maximum observed serum concentration of UCB0107 during the study	Pharmacokinetic variable: tmax: time to maximum observed serum concentration	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