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

Phase 1

Completed

• Conditions: Systemic Lupus Erythematosus; Inflammation; Rheumatoid Arthritis; Healthy
• Interventions: Drug: placebo; Drug: NNC 0151-0000-0000

• Registration Number: NCT02151409
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Study First Submitted: 2014-05-28
• Study First Submitted QC: 2014-05-28
• Study First Posted: 2014-05-30
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-08
• Last Update Posted: 2017-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	-
NNC 0151-0000-0000 i.v.	NNC 0151-0000-0000	Dose escalation trial
NNC 0151-0000-0000 s.c.	NNC 0151-0000-0000	Dose escalation trial

Primary Outcome Measures

Name	Time	Method
Adverse events (AEs)	Week 0-10

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇳🇱 Groningen, Netherlands