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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Inflammation; Systemic Lupus Erythematosus; Rheumatoid Arthritis

Treatments: Drug: NNC 0151-0000-0000; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02151409

NN8209-1940

2008-000731-18 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups, including a placebo group

NNC 0151-0000-0000 i.v.

Experimental group

Description:

Dose escalation trial

Treatment:

Drug: NNC 0151-0000-0000

Drug: NNC 0151-0000-0000

NNC 0151-0000-0000 s.c.

Experimental group

Description:

Dose escalation trial

Treatment:

Drug: NNC 0151-0000-0000

Drug: NNC 0151-0000-0000

Placebo

Placebo Comparator group

Treatment:

Drug: placebo