Dose-escalation Trial of Anti-C5aR Antibody in Healthy Subjects

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-10-31

Brief Summary

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This trial is conducted in Europe. The aim of this trial is to develop a complement system targeted monoclonal antibody (mAb) to be used in treatment of subjects with chronic autoimmune diseases.

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Detailed Description

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Conditions

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Inflammation Systemic Lupus Erythematosus Rheumatoid Arthritis Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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NNC 0151-0000-0000 i.v.

Dose escalation trial

Group Type EXPERIMENTAL

NNC 0151-0000-0000

Intervention Type DRUG

A single dose (SD), administrated i.v. (intravenous) at 8 dose levels.

NNC 0151-0000-0000 s.c.

Dose escalation trial

Group Type EXPERIMENTAL

NNC 0151-0000-0000

Intervention Type DRUG

A single dose (SD), administrated s.c. (subcutaneously) at 7 dose levels

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

A single dose (SD), administrated i.v. (intravenous) or s.c. (subcutaneously).

Interventions

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NNC 0151-0000-0000

A single dose (SD), administrated i.v. (intravenous) at 8 dose levels.

Intervention Type DRUG

NNC 0151-0000-0000

A single dose (SD), administrated s.c. (subcutaneously) at 7 dose levels

Intervention Type DRUG

placebo

A single dose (SD), administrated i.v. (intravenous) or s.c. (subcutaneously).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Informed consent obtained before any trial-related activities (Trial-related activities are any procedure that would not have been performed during normal management of the subject)
* Body weight (BW) below or equal to 110.0 kg
* Body Mass Index (BMI) 20.0 - 27.0 kg/m\^2, both inclusive
* Good state of health: evidenced by medical history, physical examination and results of laboratory examinations

Exclusion Criteria

* History of known or suspected cardiovascular diseases including: supine systolic blood pressure (BP) above or equal to 140 mmHg or below 90 mm Hg, diastolic BP above oe equal to 90 mm Hg or below 40 mm Hg, heart rate (HR) in supine position above 100 beats/minute or below 45 beats/minute
* Hepatic insufficiency: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above Upper Limit of Normal (ULN) (retesting is permitted within one week if first test is elevated but below 1.5 fold ULN)
* Renal insufficiency: Serum creatinine above ULN
* Positive for humane immunodeficiency virus (HIV) (by test)
* Positive for hepatitis B (HBV) or hepatitis C (HCV) (by test)

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes