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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02151409
• Date of registration: 28/05/2014
• Prospective Registration: No
• Primary sponsor: Novo Nordisk A/S
• Public title: Dose-escalation Trial of Anti-C5aR Antibody in Healthy Subjects
• Scientific 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.
• Date of first enrolment: June 2008
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02151409
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

Netherlands

Contacts

• Name: Global Clinical Registry (GCR, 1452)
• Affiliation: Novo Nordisk A/S

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Inflammation

Healthy

Systemic Lupus Erythematosus

Intervention(s)

Drug: placebo

Drug: NNC 0151-0000-0000

Primary Outcome(s)

Adverse events (AEs) [Time Frame: Week 0-10]

Secondary ID(s)

2008-000731-18

NN8209-1940

Source(s) of Monetary Support

Please refer to primary and secondary sponsors