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

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT02151409
Collaborator
(none)
60
Enrollment
1
Location
3
Arms
16
Duration (Months)
3.8
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: NNC 0151-0000-0000
  • Drug: NNC 0151-0000-0000
  • Drug: placebo
 Phase 1

Study Design

Study Type:
Interventional
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 :
Jun 1, 2008
Actual Primary Completion Date :
Oct 1, 2009
Actual Study Completion Date :
Oct 1, 2009

Arms and Interventions

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

Primary Outcome Measures

  1. Adverse events (AEs) [Week 0-10]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Novo Nordisk Investigational Site Groningen Netherlands 9728 NZ

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

  • Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT02151409
Other Study ID Numbers:
  • NN8209-1940
  • 2008-000731-18
First Posted:
May 30, 2014
Last Update Posted:
Feb 9, 2017
Last Verified:
Feb 1, 2017
Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Inflammation

Study Results

No Results Posted as of Feb 9, 2017