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

• ClinicalTrials.gov Identifier: NCT02151409
• Recruitment Status: Completed
• First Posted: May 30, 2014
• Last Update Posted: February 9, 2017
• Sponsor: Novo Nordisk A/S
• Information provided by (Responsible Party): Novo Nordisk A/S

Tracking Information

• First Submitted Date: May 28, 2014
• First Posted Date: May 30, 2014
• Last Update Posted Date: February 9, 2017
• Study Start Date: June 2008
• Actual Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 28, 2014): Adverse events (AEs) [ Time Frame: Week 0-10 ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Dose-escalation Trial of Anti-C5aR Antibody in Healthy Subjects
• 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.
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

• Inflammation
• Systemic Lupus Erythematosus
• Rheumatoid Arthritis
• Healthy

Intervention

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

Study Arms

• Experimental: NNC 0151-0000-0000 i.v.
  Dose escalation trial
  Intervention: Drug: NNC 0151-0000-0000
• Experimental: NNC 0151-0000-0000 s.c.
  Dose escalation trial
  Intervention: Drug: NNC 0151-0000-0000
• Placebo Comparator: Placebo
  Intervention: Drug: placebo

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 28, 2014): 60
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: October 2009
• Actual Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

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)

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT02151409
• Other Study ID Numbers: NN8209-1940; 2008-000731-18 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Novo Nordisk A/S
• Original Responsible Party: Same as current
• Current Study Sponsor: Novo Nordisk A/S
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Novo Nordisk A/S
• Verification Date: February 2017