NOX-E36 First-in-Human (FIH) Study

Phase 1

Completed

• Conditions: Chronic Inflammatory Diseases; Type 2 Diabetes Mellitus; Systemic Lupus Erythematosus
• Interventions: Drug: Placebo; Drug: NOX-E36

• Registration Number: NCT00976729
• Lead Sponsor: TME Pharma AG

Brief Summary

This is the first time NOX-E36 will be administered to man. The principal aim of this study is to obtain safety and tolerability data when NOX-E36 is administered by single intravenous (IV) and subcutaneous (SC) doses to healthy male and female subjects. This information, together with the pharmacokinetic and pharmacodynamic data, will help establish the doses, dosage regimen and route of administration suitable for multiple dose administration to healthy volunteers, followed by the studies in the patient population.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-09-11
• Study First Submitted QC: 2009-09-11
• Study First Posted: 2009-09-14
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-12
• Last Update Posted: 2013-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Healthy male and female subjects
• Body mass index (BMI) between 19.0 and 29.0 kg/m2 inclusive
• Body weight between 50 and 100 kg inclusive
• Creatinine clearance of greater than 80 mL/min

Exclusion Criteria

• Male and female subjects who are not or whose partners are not willing to use appropriate contraception methods
• Intake of any prescribed systemic or topical medication within 14 days prior to dosing
• Intake of any non-prescribed systemic or topical medication (including herbal remedies) within 7 days prior to dosing (with the exception of vitamin/mineral supplements)
• Supine blood pressure and supine pulse rate higher than 140/90 mmHg and 100 beats per minute (bpm), respectively, or lower than 90/50 mmHg and 40 bpm, respectively, as confirmed by a repeat assessment
• History of any clinically significant neurological, dermatological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological or other major disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo i.v.	Placebo	-
0.03 mg/kg i.v.	NOX-E36	-
0.09 mg/kg i.v.	NOX-E36	-
0.25 mg/kg i.v.	NOX-E36	-
0.5 mg/kg i.v.	NOX-E36	-
1.0 mg/kg i.v.	NOX-E36	-
2.0 mg/kg i.v.	NOX-E36	-
Placebo s.c.	Placebo	-
0.25 mg/kg s.c.	NOX-E36	-
0.5 mg/kg s.c.	NOX-E36	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of NOX-E36 by means of adverse events, vital signs, laboratory parameters, 12-lead ECG and immunogenicity assessment	throughout the entire study

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters in plasma and urine	throughout the entire study
Pharmacodynamic profile	throughout the entire study