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Completed

NCT Number: NCT02873767

A First-In-Human Study With a Single Dose UCB4019 in Healthy Volunteers

This study is designed to evaluate the safety and tolerability of single ascending doses of UCB4019 administered by subcutaneous injection in healthy subjects.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Up0028 001

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Good physical and mental health
  • At least 18 and less than 65 years of age
  • Female subjects of childbearing potential must agree to use a highly effective method of birth control, during the study and for a period of 3 months after their last dose of study drug

Exclusion criteria

  • Total Immunoglobulin G <7 g/L or >16 g/L at the Screening Visit
  • Absolute neutrophil count <1.5x10^9/L and/or lymphocyte count <1.0x10^9/L
  • Known viral hepatitis, has a positive test for Hepatitis B surface antigen or is Hepatitis C virus antibody positive
  • Positive test to Human Immunodeficiency Virus (HIV) 1/2 antibodies
  • Past medical history or family history of primary immunodeficiency
  • Evidence of latent/active Tuberculosis (TB)
  • Active infection or a serious infection within 6 weeks before the first dose of IMP
  • Renal impairment
  • Hepatic impairment
  • Vaccination within 6 weeks before the Screening Visit or intent to have a vaccination before Day 43 of the Safety Follow-up Period
  • Subject is splenectomized
  • received any IMP or experimental procedure within 90 days before the first dose of IMP
  • received UCB7665 in a clinical study

Treatment and study plan

PR1

Drug
  • Active substance: UCB4019
  • Route of Administration: subcutaneously

PL1

Other
  • Active substance: Placebo
  • Concentration: 0.9 % saline
  • Route of Administration: subcutaneously

Primary outcomes

  1. Incidence of treatment emergent adverse events during the study

    Time frame: Day 1 up to Day 57

    An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.

Secondary outcomes

  1. Maximum plasma concentration (Cmax)

    Time frame: Pharmacokinetic samples will be taken predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours postdose and Days 7, 10, 13, 16, 19

  2. Area under the curve from 0 to time t, the time of last quantifiable concentration [(AUC0-t)]

    Time frame: Pharmacokinetic samples will be taken predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours postdose and Days 7, 10, 13, 16, 19

  3. Time to reach Cmax (Tmax)

    Time frame: Pharmacokinetic samples will be taken predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours postdose and Days 7, 10, 13, 16, 19

  4. Change from Baseline in total Immunoglobulin G (IgG) concentration at day 7

    Time frame: Predose (Day 1), Day 7

  5. Change from Baseline in total Immunoglobulin G (IgG) concentration at day 10

    Time frame: Predose (Day 1), Day 10

  6. Change from Baseline in total Immunoglobulin G (IgG) concentration at day 13

    Time frame: Predose (Day 1), Day 13

Sponsors and collaborators

Lead sponsor

UCB Biopharma S.P.R.L.

Industry

Registry information

Official study title

A Subject-Blind, Investigator-Blind, Randomized, Placebo-Controlled, First-In-Human Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending Subcutaneous Doses of UCB4019 in Healthy Subjects

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 19, 2016
Registry last updated
Feb 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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