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

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



Sponsors


Source

UCB Pharma

Oversight Info

Has Dmc

Yes

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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.

Overall Status

Recruiting

Start Date

2018-02-16

Completion Date

2018-11-15

Primary Completion Date

2018-11-15

Phase

Phase 1

Study Type

Interventional

Primary Outcome

Measure

Time Frame

The incidence of Adverse Events (AEs) during the study
During the study from Visit 1 up to the Safety Follow-Up Visit (Week 20)

Secondary Outcome

Measure

Time Frame

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)
The total Clearance (CL) for UCB0107 in serum
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
Pharmacokinetic samples will be taken at pre-defined time points throughout study completion (up to Week 20)
CSF/serum ratio of antibody concentrations
Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20)

Enrollment

52

Condition


Intervention

Intervention Type

Drug

Intervention Name


Description

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

Arm Group Label

UCB0107


Intervention Type

Other

Intervention Name


Description

Pharmaceutical form: intravenous infusion
Route of administration: intravenous use

Arm Group Label

Placebo



Eligibility

Criteria

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

Gender

Male

Minimum Age

18 Years

Maximum Age

75 Years

Healthy Volunteers

Accepts Healthy Volunteers


Overall Official

Last Name

Role

Affiliation

UCB Cares
Study Director
001 844 599 2273 (UCB)

Overall Contact

Last Name

UCB Cares

Phone

+1844599

Phone Ext

2273

Email

UCBCares@ucb.com


Location

Facility

Status

Up0047 001
Berlin Germany
Recruiting

Location Countries

Country

Germany


Verification Date

2018-06-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Sponsor


Keywords


Has Expanded Access

No

Secondary Id

2017-003315-19

Number Of Arms

2

Arm Group

Arm Group Label

UCB0107

Arm Group Type

Experimental

Description

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.


Arm Group Label

Placebo

Arm Group Type

Placebo Comparator

Description

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



Firstreceived Results Date

N/A

Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Basic Science

Masking

Double (Participant, Investigator)


Study First Submitted

February 22, 2018

Study First Submitted Qc

March 12, 2018

Study First Posted

March 13, 2018

Last Update Submitted

June 12, 2018

Last Update Submitted Qc

June 12, 2018

Last Update Posted

June 14, 2018


ClinicalTrials.gov processed this data on August 23, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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