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Pharmacokinetic (PK)/Pharmacodynamic (PD), Study of Single-dose Subcutaneous CDP6038 in Healthy Japanese Male Subjects

NCT ID: NCT01262794

Last Updated: 2011-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-09-30

Brief Summary

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To evaluate the safety and tolerability of CDP6038 following single dose subcutaneous (sc) administration of CDP6038 to Japanese subjects.

To evaluate the Pharmacokinetics of CDP6038 following single dose sc administration of CDP6038 to Japanese subjects

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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CDP6038 0.3 mg/kg

Group Type EXPERIMENTAL

CDP6038

Intervention Type BIOLOGICAL

100 mg/mL solution for injection, single dose

CDP6038 1 mg/kg

Group Type EXPERIMENTAL

CDP6038

Intervention Type BIOLOGICAL

100 mg/mL solution for injection, single dose

CDP6038 3 mg/kg

Group Type EXPERIMENTAL

CDP6038

Intervention Type BIOLOGICAL

100 mg/mL solution for injection, single dose

CDP6038 6 mg/kg

Group Type EXPERIMENTAL

CDP6038

Intervention Type BIOLOGICAL

100 mg/mL solution for injection, single dose

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

0.9% sodium chloride for injection Single-dose

Interventions

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CDP6038

100 mg/mL solution for injection, single dose

Intervention Type BIOLOGICAL

Placebo

0.9% sodium chloride for injection Single-dose

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy Japanese volunteers

Exclusion Criteria

* Subject has participated in any other clinical drug study (including a biologic product or a medical device) within 5 PK half-lives or 3 months (whichever is longer) prior to Screening, or the subject is currently participating in another clinical study.
* Subject is not healthy (eg, taking any drug treatments, any psychological or emotional problems, a drug/alcohol abuse or a having a history of drug/alcohol abuse, having abnormal safety parameters)
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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UCB Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

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Guildford, Surrey, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2010-022543-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

RA0074

Identifier Type: -

Identifier Source: org_study_id