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

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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02151409

Enrollment

Registered

2014-05-30

Start date

2008-06-30

Completion date

2009-10-31

Last updated

2017-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Inflammation, Rheumatoid Arthritis, Systemic Lupus Erythematosus

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.

Interventions

DRUGNNC 0151-0000-0000

A single dose (SD), administrated i.v. (intravenous) at 8 dose levels.

DRUGplacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

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)

Design outcomes

Primary

Measure	Time frame
Adverse events (AEs)	Week 0-10

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026