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A First-In-Human Study With a Single Dose UCB7665 in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02220153
Recruitment Status : Completed
First Posted : August 19, 2014
Last Update Posted : October 5, 2015
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
UCB Pharma ( UCB Celltech )

Brief Summary:
This study is designed to evaluate the safety and tolerability of single ascending doses of UCB7665 administered by intravenous or subcutaneous infusion in healthy subjects.

Condition or disease Intervention/treatment Phase
Healthy Biological: UCB7665 Intravenous 1 Biological: UCB7665 Intravenous 2 Biological: UCB7665 Intravenous 3 Biological: UCB7665 Intravenous 4 Biological: UCB7665 Intravenous 5 Biological: UCB7665 Subcutaneous 1 Biological: UCB7665 Subcutaneous 2 Biological: Intravenous Placebo Biological: Subcutaneous Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Subject-Blind, Investigator-blind, Randomized, Placebo-controlled, First-in-human Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending Intravenous and Subcutaneous Doses of UCB7665 in Healthy Subjects
Study Start Date : July 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Arm Intervention/treatment
Experimental: UCB7665 Intravenous 1
Single dose calculated based on body weight for 60 minutes intravenous infusion.
Biological: UCB7665 Intravenous 1
  • Active substance: UCB7665
  • Pharmaceutical form: solution
  • Concentration: 140 mg/mL
  • Route of Administration: intravenous infusion
Experimental: UCB7665 Intravenous 2
Single dose calculated based on body weight for 60 minutes intravenous infusion.
Biological: UCB7665 Intravenous 2
  • Active substance: UCB7665
  • Pharmaceutical form: solution
  • Concentration: 140 mg/mL
  • Route of Administration: intravenous infusion
Experimental: UCB7665 Intravenous 3
Single dose calculated based on body weight for 60 minutes intravenous infusion.
Biological: UCB7665 Intravenous 3
  • Active substance: UCB7665
  • Pharmaceutical form: solution
  • Concentration: 140 mg/mL
  • Route of Administration: intravenous infusion
Experimental: UCB7665 Intravenous 4
Single dose calculated based on body weight for 60 minutes intravenous infusion.
Biological: UCB7665 Intravenous 4
  • Active substance: UCB7665
  • Pharmaceutical form: solution
  • Concentration: 140 mg/mL
  • Route of Administration: intravenous infusion
Experimental: UCB7665 Intravenous 5
Single dose calculated based on body weight for 60 minutes intravenous infusion.
Biological: UCB7665 Intravenous 5
  • Active substance: UCB7665
  • Pharmaceutical form: solution
  • Concentration: 140 mg/mL
  • Route of Administration: intravenous infusion
Experimental: UCB7665 Subcutaneous 1
Single dose calculated based on body weight for 60 minutes subcutaneous infusion.
Biological: UCB7665 Subcutaneous 1
  • Active substance: UCB7665
  • Pharmaceutical form: solution
  • Concentration: 140 mg/mL
  • Route of Administration: subcutaneous infusion
Experimental: UCB7665 Subcutaneous 2
Single dose calculated based on body weight for 60 minutes subcutaneous infusion.
Biological: UCB7665 Subcutaneous 2
  • Active substance: UCB7665
  • Pharmaceutical form: solution
  • Concentration: 140 mg/mL
  • Route of Administration: subcutaneous infusion
Placebo Comparator: Intravenous Placebo
Single dose placebo comparator for each active arm of intravenous infusion.
Biological: Intravenous Placebo
  • Active substance: Placebo
  • Pharmaceutical form: solution
  • Concentration: 0.9 % saline
  • Route of Administration: intravenous infusion
Placebo Comparator: Subcutaneous Placebo
Single dose placebo comparator for each active arm of subcutaneous infusion.
Biological: Subcutaneous Placebo
  • Active substance: Placebo
  • Pharmaceutical form: solution
  • Concentration: 0.9 % saline
  • Route of Administration: subcutaneous infusion



Primary Outcome Measures :
  1. Incidence of adverse events during the study [ Time Frame: Day -1 up to Day 85 ]

Secondary Outcome Measures :
  1. Maximum plasma concentration (Cmax) [ Time Frame: Predose (Day 1) up to Day 85 ]
    The value of the maximum plasma concentration will be directly obtained from the observed plasma concentration versus time curves. Pharmacokinetic samples will be taken predose, at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.

  2. Area under the curve from 0 to infinity (AUC) [ Time Frame: Predose (Day 1) up to Day 85 ]
    AUC will be calculated using plasma concentrations taken at predose, at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.

  3. Area under the curve from time 0 to time t, the time of last quantifiable concentration [AUC(0-t)] [ Time Frame: Predose (Day 1) up to Day 85 ]
    AUC(0-t) will be calculated using plasma concentrations taken at predose, at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.

  4. Time to reach Cmax (Tmax) [ Time Frame: Predose (Day 1) up to Day 85 ]
    Tmax will be directly obtained from the observed plasma concentration versus time curves, using plasma concentrations taken at predose, at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.

  5. Total Immunoglobulin G (IgG ) concentrations [ Time Frame: Predose (Day 1) up to Day 85 ]
    Total Immunoglobulin G will be measured at predose, 24, 48, 72, and 96 hours postdose; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.

  6. Immunoglobulin G1 subclass concentrations [ Time Frame: Predose (Day 1) up to Day 85 ]
    Immunoglobulin subclass will be measured at predose, 24, 48, 72, and 96 hours postdose; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.

  7. Immunoglobulin G2 subclass concentrations [ Time Frame: Predose (Day 1) up to Day 85 ]
    Immunoglobulin subclass will be measured at predose, 24, 48, 72, and 96 hours postdose; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.

  8. Immunoglobulin G3 subclass concentrations [ Time Frame: Predose (Day 1) up to Day 85 ]
    Immunoglobulin subclass will be measured at predose, 24, 48, 72, and 96 hours postdose; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.

  9. Immunoglobulin G4 subclass concentrations [ Time Frame: Predose (Day 1) up to Day 85 ]
    Immunoglobulin subclass will be measured at predose, 24, 48, 72, and 96 hours postdose; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and female volunteers of non-childbearing potential who gave their consent to the written informed consent form
  • Healthy volunteers in the age between 18 and 64 years old with normal weight as determined by a body mass index (BMI) between 18 and 30 kg/m^2, with a body weight of at least 50 kg for male subjects or 45 kg for female subjects
  • Subjects has blood pressure (BP) and pulse within normal range in a supine position after 5 minutes rest
  • Subject has clinical laboratory test results within the reference ranges of the testing laboratory or test results that are outside the specified ranges and that are deemed as clinically non-significant
  • Subject's electrocardiogram (ECG) is considered "normal" or "abnormal" but clinically non-significant

Exclusion Criteria:

  • Subject has had significant blood loss, or has donated blood in excess of 400 mL of blood or blood products within 90 days before Day -2, or plans to donate blood during the clinical study
  • Subject has a total Immuneglobulin G <7 g/L or >16 g/L at the Screening Visit
  • Subject has absolute neutrophil count <1.5x10^9/L and/or lymphocyte count <1.0x10^9/L
  • Subject has known viral hepatitis, has a positive test for Hepatitis B surface antigen or is Hepatitis C virus antibody positive
  • Subject tests positive to Human Immunodeficiency Virus (HIV) 1/2 antibodies
  • Subject has a past medical history or family history of primary immunodeficiency
  • Subject is splenectomized
  • Subject has a positive TIGRA (T cell interferon γ release assay) at the Screening Visit. If TIGRA is not available, purified protein derivative (PPD) skin test can be substituted and/or chest x-ray performed within 6 months before the Screening Visit showing no evidence of latent/active Tuberculosis (TB)
  • Subject has past (in the last 12 months ) or present substance abuse/dependence or concurrent medical conditions that in the opinion of the investigator could confound clinical study interpretation or affect the subject's ability to fully participate in the clinical study
  • Subject has a known hypersensitivity to any components of the Investigational Medicinal Product (IMP)
  • Subject has an active infection or has had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks before the first dose of IMP
  • Subject has 12-lead electrocardiogram (ECG) with changes considered to be clinically significant upon medical review
  • Subject has renal impairment
  • Subject has hepatic impairment
  • Subject has corrected serum calcium of >11.5 mg/dL (>2.9 mmol/L) or <8.0 mg/dL (<2.0 mmol/L) at the Screening Visit
  • Subject has active neoplastic disease or history of neoplastic disease within 5 years of entry in the clinical study
  • Subject has any other acute or chronic illness which, in the opinion of the investigator or study physician, could pose a threat or harm to the subjects
  • Subject has received a vaccination within 6 weeks before the Screening Visit or intends to have a vaccination before Day 43 of the Safety Follow-up Period
  • Subject has received any IMP or experimental procedure within 90 days before the first dose of IMP
  • Subject requires a treatment other than Paracetamol during the clinical study
  • Subject is a vulnerable subject (e.g. subject kept in detention) (Declaration of Helsinki, 1996)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220153


Locations
United Kingdom
001
Harrow, Middlesex, United Kingdom
Sponsors and Collaborators
UCB Celltech
Parexel
Investigators
Study Director: UCB Clinical Trial Call Center UCB Pharma

Responsible Party: UCB Celltech
ClinicalTrials.gov Identifier: NCT02220153     History of Changes
Other Study ID Numbers: UP0018
2013-005469-38 ( EudraCT Number )
First Posted: August 19, 2014    Key Record Dates
Last Update Posted: October 5, 2015
Last Verified: October 2015

Keywords provided by UCB Pharma ( UCB Celltech ):
Monoclonal antibody
subjects
First in human