Trial | NCT00976729  Report issue

Title

NOX-E36 First-in-Human (FIH) Study
NOX-E36 - A Phase I, Double-Blind, Placebo Controlled, Single Intravenous and Subcutaneous Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Subjects

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    nox-e36 ...

  • Study Participants

    72
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.
Study Started
May 31
2009
Primary Completion
Dec 31
2009
Study Completion
Dec 31
2009
Last Update
Feb 13
2013
Estimate

Drug NOX-E36

single ascending IV doses, ranging from 0.03 mg/kg to 2.0 mg/kg

Drug NOX-E36

single SC doses, at safe and tolerable dose level

Drug Placebo

Placebo i.v. Placebo Comparator

0.03 mg/kg i.v. Experimental

0.09 mg/kg i.v. Experimental

0.25 mg/kg i.v. Experimental

0.5 mg/kg i.v. Experimental

1.0 mg/kg i.v. Experimental

2.0 mg/kg i.v. Experimental

Placebo s.c. Placebo Comparator

0.25 mg/kg s.c. Experimental

0.5 mg/kg s.c. Experimental

Criteria 

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
No Results Posted