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

February 8, 2017 updated by: Novo Nordisk A/S

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9728 NZ
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events (AEs)
Time Frame: Week 0-10
Week 0-10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

May 28, 2014

First Submitted That Met QC Criteria

May 28, 2014

First Posted (Estimate)

May 30, 2014

Study Record Updates

Last Update Posted (Estimate)

February 9, 2017

Last Update Submitted That Met QC Criteria

February 8, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN8209-1940
  • 2008-000731-18 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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