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NCT02151409 Clinical Trial

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

Healthy Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02151409
Other study ID # NN8209-1940
Secondary ID 2008-000731-18
Status Completed
Phase Phase 1
First received May 28, 2014
Last updated February 8, 2017
Start date June 2008
Est. completion date October 2009

Study information
Verified date February 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date October 2009
Est. primary completion date October 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 55 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• NNC 0151-0000-0000
A single dose (SD), administrated i.v. (intravenous) at 8 dose levels.
• NNC 0151-0000-0000
A single dose (SD), administrated s.c. (subcutaneously) at 7 dose levels
• placebo
A single dose (SD), administrated i.v. (intravenous) or s.c. (subcutaneously).

Locations
Country Name City State
Netherlands Novo Nordisk Investigational Site Groningen

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse events (AEs) Week 0-10
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