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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02151409
Recruitment Status : Completed
First Posted : May 30, 2014
Last Update Posted : February 9, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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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.

Condition or disease Intervention/treatment Phase
Inflammation Systemic Lupus Erythematosus Rheumatoid Arthritis Healthy Drug: NNC 0151-0000-0000 Drug: placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : June 2008
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: NNC 0151-0000-0000 i.v.
Dose escalation trial
 Drug: NNC 0151-0000-0000
A single dose (SD), administrated i.v. (intravenous) at 8 dose levels.
Experimental: NNC 0151-0000-0000 s.c.
Dose escalation trial
 Drug: NNC 0151-0000-0000
A single dose (SD), administrated s.c. (subcutaneously) at 7 dose levels
Placebo Comparator: Placebo Drug: placebo
A single dose (SD), administrated i.v. (intravenous) or s.c. (subcutaneously).


Outcome Measures
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Primary Outcome Measures :
  1. Adverse events (AEs) [ Time Frame: Week 0-10 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02151409


Locations
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Netherlands
Novo Nordisk Investigational Site
Groningen, Netherlands, 9728 NZ
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

Publications of Results:
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

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02151409    
Other Study ID Numbers: NN8209-1940
2008-000731-18 ( EudraCT Number )
First Posted: May 30, 2014    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Inflammation
Pathologic Processes
 Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases