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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: PL1; Drug: PR1

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Up0028 001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo; Single dose placebo comparator for each active arm	Other: PL1; Active substance: Placebo; Concentration: 0.9 % saline; Route of Administration: subcutaneously
EXPERIMENTAL: UCB4019 Dose 1; Dose 1 calculated based on body weight	Drug: PR1; Active substance: UCB4019; Route of Administration: subcutaneously
EXPERIMENTAL: UCB4019 Dose 2; Dose 2 calculated based on body weight	Drug: PR1; Active substance: UCB4019; Route of Administration: subcutaneously
EXPERIMENTAL: UCB4019 Dose 3; Dose 3 calculated based on body weight	Drug: PR1; Active substance: UCB4019; Route of Administration: subcutaneously
EXPERIMENTAL: UCB4019 Dose 4; Dose 4 calculated based on body weight	Drug: PR1; Active substance: UCB4019; Route of Administration: subcutaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment emergent adverse events during the study	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.	Day 1 up to Day 57

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum plasma concentration (Cmax)	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
Area under the curve from 0 to time t, the time of last quantifiable concentration [(AUC0-t)]	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
Time to reach Cmax (Tmax)	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
Change from Baseline in total Immunoglobulin G (IgG) concentration at day 7	Predose (Day 1), Day 7
Change from Baseline in total Immunoglobulin G (IgG) concentration at day 10	Predose (Day 1), Day 10
Change from Baseline in total Immunoglobulin G (IgG) concentration at day 13	Predose (Day 1), Day 13

Collaborators and Investigators

• Sponsor: UCB Biopharma S.P.R.L.
• Investigators: Study Director: UCB Cares, UCB (+1 887 822 9493)

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (ACTUAL): February 1, 2017
• Study Completion (ACTUAL): February 1, 2017

Study Registration Dates

• First Submitted: August 16, 2016
• First Submitted That Met QC Criteria: August 16, 2016
• First Posted (ESTIMATE): August 19, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2017
• Last Update Submitted That Met QC Criteria: February 8, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Healthy volunteers; First in human
• Other Study ID Numbers: UP0028; 2016-000772-26 (EUDRACT_NUMBER)