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

Study Overview
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Brief Summary
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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.

Official Title
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NOX-E36 - A Phase I, Double-Blind, Placebo Controlled, Single Intravenous and Subcutaneous Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Subjects

Conditions
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Chronic Inflammatory Diseases, Type 2 Diabetes Mellitus, Systemic Lupus Erythematosus

Intervention / Treatment
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* Drug: NOX-E36
* Drug: NOX-E36
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo i.v.<br> | Drug: Placebo<br> <br> |
| Experimental: 0.03 mg/kg i.v.<br> | Drug: NOX-E36<br>* single ascending IV doses, ranging from 0.03 mg/kg to 2.0 mg/kg<br>|
| Experimental: 0.09 mg/kg i.v.<br> | Drug: NOX-E36<br>* single ascending IV doses, ranging from 0.03 mg/kg to 2.0 mg/kg<br>|
| Experimental: 0.25 mg/kg i.v.<br> | Drug: NOX-E36<br>* single ascending IV doses, ranging from 0.03 mg/kg to 2.0 mg/kg<br>|
| Experimental: 0.5 mg/kg i.v.<br> | Drug: NOX-E36<br>* single ascending IV doses, ranging from 0.03 mg/kg to 2.0 mg/kg<br>|
| Experimental: 1.0 mg/kg i.v.<br> | Drug: NOX-E36<br>* single ascending IV doses, ranging from 0.03 mg/kg to 2.0 mg/kg<br>|
| Experimental: 2.0 mg/kg i.v.<br> | Drug: NOX-E36<br>* single ascending IV doses, ranging from 0.03 mg/kg to 2.0 mg/kg<br>|
| Placebo Comparator: Placebo s.c.<br> | Drug: Placebo<br> <br> |
| Experimental: 0.25 mg/kg s.c.<br> | Drug: NOX-E36<br>* single SC doses, at safe and tolerable dose level<br>|
| Experimental: 0.5 mg/kg s.c.<br> | Drug: NOX-E36<br>* single SC doses, at safe and tolerable dose level<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters in plasma and urine |  | throughout the entire study | 
| Pharmacodynamic profile |  | throughout the entire study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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monocyte chemoattractant protein-1 (MCP-1), L-oligonucleotide aptamer, Spiegelmer