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

NCT02151409 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-02-09

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

NNC 0151-0000-0000

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

DRUG

NNC 0151-0000-0000

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

DRUG

placebo

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

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • Netherlands

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02151409 on ClinicalTrials.gov