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

Healthy Male Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03464227
• Other study ID #: UP0047
• Secondary ID: 2017-003315-19
• Status: Completed
• Phase: Phase 1
• Start date: February 16, 2018
• Est. completion date: December 1, 2018

Study information

• Verified date: December 2018
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Male Volunteers

Intervention

Drug:
• UCB0107
Pharmaceutical form: solution for infusion Route of administration: intravenous use

Other:
• Placebo
Pharmaceutical form: intravenous infusion Route of administration: intravenous use

Locations

Country	Name	City	State
Germany	Up0047 001	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma S.P.R.L.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)