Dose-escalation Trial of Anti-C5aR Antibody in Healthy Subjects
A Randomised, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Trial of Anti-C5aR Antibody (NNC 0151-0000-0000) Administered by i.v. Infusion or s.c. Injection in Healthy Subjects.
2 other identifiers
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 28, 2014
CompletedFirst Posted
Study publicly available on registry
May 30, 2014
CompletedFebruary 9, 2017
February 1, 2017
1.3 years
May 28, 2014
February 8, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse events (AEs)
Week 0-10
Study Arms (3)
NNC 0151-0000-0000 i.v.
EXPERIMENTALDose escalation trial
NNC 0151-0000-0000 s.c.
EXPERIMENTALDose escalation trial
Placebo
PLACEBO COMPARATORInterventions
A single dose (SD), administrated i.v. (intravenous) at 8 dose levels.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Groningen, 9728 NZ, Netherlands
Related Publications (1)
The first-in-human trial of the humanised monoclonal antibody NNC 0151-0000-0000 blocking the C5a receptor (C5aR). EULAR (European League Against Rheumatism) 2009; Country: Denmark City: Copenhagen
RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2014
First Posted
May 30, 2014
Study Start
June 1, 2008
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
February 9, 2017
Record last verified: 2017-02