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

NCT03605082 | Completed Phase 1

• 2 other identifiers: UP00652018-000475-32
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

UCB0107; Phase 1

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

UCB0107

EXPERIMENTAL

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

Drug: UCB0107

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

UCB0107 DRUG

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

UCB0107

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Biopharma S.P.R.L.: lead

Study Sites (1)

Up0065 001

London, United Kingdom

Location

Study Officials

• UCB Cares

  001 844 599 2273 (UCB)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2018
• First Posted: July 30, 2018
• Study Start: July 25, 2018
• Primary Completion: March 11, 2019
• Study Completion: March 11, 2019
• Last Updated: March 14, 2019

Record last verified: 2019-03

Locations

GB (1)