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Completed

NCT Number: NCT02151409

Dose-escalation Trial of Anti-C5aR Antibody 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.

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Key information

Conditions

Inflammation Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Healthy Immune System Diseases Joint Diseases Lupus Erythematosus, Systemic Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases Systemic Lupus Erythematosus

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Groningen, 9728 NZ, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

NNC 0151-0000-0000

Drug

A single dose (SD), administrated i.v. (intravenous) at 8 dose levels.

Placebo

Drug

A single dose (SD), administrated i.v. (intravenous) or s.c. (subcutaneously).

Primary outcomes

  1. Adverse events (AEs)

    Time frame: Week 0-10

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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.

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 30, 2014
Registry last updated
Feb 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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