Dose-escalation Trial of Anti-C5aR Antibody in Healthy Su... | NCT02151409

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

NCT02151409

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Feb 9, 2017Estimated

Enrollment

60Actual

Phase

Phase 1

Conditions

Inflammation
Systemic Lupus Erythematosus
Rheumatoid Arthritis
Healthy

Interventions

NNC 0151-0000-0000
NNC 0151-0000-0000
placebo

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2008-000731-18	EudraCT Number

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Oct 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

May 28, 2014

First Submission Date that Met QC Criteria

May 28, 2014

First Posted Date

May 30, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 8, 2017

Last Update Posted Date

Feb 9, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NNC 0151-0000-0000 i.v.	Experimental	Dose escalation trial	Drug: NNC 0151-0000-0000
NNC 0151-0000-0000 s.c.	Experimental	Dose escalation trial	Drug: NNC 0151-0000-0000
Placebo	Placebo Comparator		Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NNC 0151-0000-0000	Drug	A single dose (SD), administrated i.v. (intravenous) at 8 dose levels.	NNC 0151-0000-0000 i.v.

Measure	Description	Time Frame
Adverse events (AEs)		Week 0-10

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Groningen		9728 NZ	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Result	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

ID	Term
D007249	Inflammation
D008180	Lupus Erythematosus, Systemic
D001172	Arthritis, Rheumatoid

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases