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

NCT03464227 | Completed Phase 1 DMC

• 2 other identifiers: UP00472017-003315-19
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Male Volunteers

Keywords

Phase 1; UCB0107

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• The Maximum concentration (Cmax) for UCB0107 in serum and cerebrospinal fluid

  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

  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

  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

  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

  Pharmacokinetic samples will be taken at pre-defined time points throughout study completion (up to Week 20)

Study Arms (2)

UCB0107

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Subjects randomized to this arm will receive matching Placebo to UCB0107. This arm will consist of a maximum of 7 cohorts.

Other: Placebo

Interventions

UCB0107 DRUG

* Pharmaceutical form: solution for infusion * Route of administration: intravenous use

UCB0107

Placebo OTHER

* Pharmaceutical form: intravenous infusion * Route of administration: intravenous use

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Biopharma S.P.R.L.: lead

Study Sites (1)

Up0047 001

Berlin, Germany

Location

Study Officials

• UCB Cares

  001 844 599 2273 (UCB)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: March 13, 2018
• Study Start: February 16, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 12, 2018

Record last verified: 2018-12

Locations

DE (1)