A Study to Test the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending Intravenous Doses of UCB0107 in Healthy Male Subjects

A Subject-Blind, Investigator-Blind, Randomized, Placebo-Controlled, First-in-Human Study to Evaluate Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Intravenous Doses of UCB0107 in Healthy Male Subjects

The purpose of the study is to evaluate the safety and tolerability of single ascending doses of UCB0107 administered by intravenous (iv) infusion in healthy male subjects.

Study Overview

• Status: Completed
• Conditions: Healthy Male Volunteers
• Intervention / Treatment: Drug: UCB0107; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Up0047 001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Subject is male, >= 18 and <= 75 years of age
• Subject has a body mass index (BMI) >= 18.0 and < 30.0 kg/m^2, with a body weight of at least 50 kg and maximum 100 kg
• Subject is in good physical and mental health
• Subject has clinical laboratory test results within the reference ranges of the laboratory
• Subject's electrocardiogram (ECG) is considered "normal," or "abnormal" but clinically non-significant (as interpreted by the investigator)
• Male subject confirms that, during the study period and for a period of 6 months or 5 half-lives of the investigational medicinal product (IMP) (whichever is longer), when having sexual intercourse with a woman of childbearing potential, a method of efficient contraception will be used, including a barrier AND an additional highly effective contraceptive method by the female partner

Exclusion Criteria:

• Subject is an employee or direct relative of an employee of the contract research organization (CRO) or UCB
• Subject has previously been assigned to treatment in this study or in another study of the medication under investigation in this study
• Subject is considered to be a vulnerable participant
• Subject has had major surgery (including joint surgery) within 6 months prior to Screening, or has planned surgery within 6 months after study treatment
• Subject has an active infection (eg, sepsis, pneumonia, abscess) or has had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 4 weeks before the first dose of IMP

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UCB0107; Subjects randomized to this arm will receive UCB0107. This arm will consist of a maximum of 7 cohorts. The dose for cohort 1 will be fixed, proposed doses for cohorts 2,3,4,5,6 and 7 may be adapted based upon recommendation by the Safety Review Group.	Drug: UCB0107; Pharmaceutical form: solution for infusion; Route of administration: intravenous use
Placebo Comparator: Placebo; Subjects randomized to this arm will receive matching Placebo to UCB0107. This arm will consist of a maximum of 7 cohorts.	Other: Placebo; Pharmaceutical form: intravenous infusion; Route of administration: intravenous use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of Adverse Events (AEs) during the study	An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	During the study from Visit 1 up to the Safety Follow-Up Visit (Week 20)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Maximum concentration (Cmax) for UCB0107 in serum and cerebrospinal fluid	Cmax: maximum observed serum concentration	Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20)
The area under the concentration-time curve from time 0 to infinity (AUC) in serum and cerebrospinal fluid	AUC: area under the concentration-time curve from time 0 to infinity	Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20)
The area under the concentration-time curve from time 0 to time t, the time of the last quantifiable concentration (AUC(0-t)) in serum and cerebrospinal fluid	AUC(0-t): area under the concentration-time curve from time 0 to time t, the time of the last quantifiable concentration	Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20)
The time to maximum concentration (tmax) for UCB0107 in serum and cerebrospinal fluid	tmax: time to maximum observed serum concentration	Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20)
The terminal half-life (t½) of UCB0107 in serum	t1/2: terminal half-life	Pharmacokinetic samples will be taken at pre-defined time points throughout study completion (up to Week 20)
The total Clearance (CL) for UCB0107 in serum	CL: clearance	Pharmacokinetic samples will be taken at pre-defined time points throughout study completion (up to Week 20)
The volume of distribution (Vz) for UCB0107 in serum	Vz: volume of distribution.	Pharmacokinetic samples will be taken at pre-defined time points throughout study completion (up to Week 20)
CSF/serum ratio of antibody concentrations	Ratio of the antibody concentrations in cerebrospinal fluid and serum	Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20)

Collaborators and Investigators

• Sponsor: UCB Biopharma S.P.R.L.

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2018
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: February 22, 2018
• First Submitted That Met QC Criteria: March 12, 2018
• First Posted (Actual): March 13, 2018

Study Record Updates

• Last Update Posted (Actual): December 12, 2018
• Last Update Submitted That Met QC Criteria: December 11, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Phase 1; UCB0107
• Other Study ID Numbers: UP0047; 2017-003315-19 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No