Back to resultsDose-escalation Trial of Anti-C5aR Antibody in Healthy Subjects
Primary Purpose
Inflammation, Systemic Lupus Erythematosus, Rheumatoid Arthritis
Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
NNC 0151-0000-0000
NNC 0151-0000-0000
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Inflammation
Eligibility Criteria
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)
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
NNC 0151-0000-0000 i.v.
NNC 0151-0000-0000 s.c.
Placebo
Arm Description
Dose escalation trial
Dose escalation trial
Outcomes
Primary Outcome Measures
Adverse events (AEs)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02151409
Brief Title
Dose-escalation Trial of Anti-C5aR Antibody in Healthy Subjects
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Systemic Lupus Erythematosus, Rheumatoid Arthritis, Healthy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NNC 0151-0000-0000 i.v.
Arm Type
Experimental
Arm Description
Dose escalation trial
Arm Title
NNC 0151-0000-0000 s.c.
Arm Type
Experimental
Arm Description
Dose escalation trial
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
NNC 0151-0000-0000
Intervention Description
A single dose (SD), administrated i.v. (intravenous) at 8 dose levels.
Intervention Type
Drug
Intervention Name(s)
NNC 0151-0000-0000
Intervention Description
A single dose (SD), administrated s.c. (subcutaneously) at 7 dose levels
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
A single dose (SD), administrated i.v. (intravenous) or s.c. (subcutaneously).
Primary Outcome Measure Information:
Title
Adverse events (AEs)
Time Frame
Week 0-10
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Groningen
ZIP/Postal Code
9728 NZ
Country
Netherlands
12. IPD Sharing Statement
Citations:
Citation
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
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Dose-escalation Trial of Anti-C5aR Antibody in Healthy Subjects
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