Dose-escalation Trial of Anti-C5aR Antibody in Healthy Subjects
NCT02151409 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2017-02-09
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
-
A single dose (SD), administrated i.v. (intravenous) or s.c. (subcutaneously).
Sponsors & Collaborators
- lead INDUSTRY
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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