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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00976729
• Date of registration: 11/09/2009
• Prospective Registration: No
• Primary sponsor: NOXXON Pharma AG
• Public title: NOX-E36 First-in-Human (FIH) Study
• Scientific title: NOX-E36 - A Phase I, Double-Blind, Placebo Controlled, Single Intravenous and Subcutaneous Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Subjects
• Date of first enrolment: May 2009
• Target sample size: 72
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00976729
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United Kingdom

Contacts

• Name: Grit Landgraf, PhD
• Affiliation: Noxxon AG

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus

Systemic Lupus Erythematosus

Chronic Inflammatory Diseases

Intervention(s)

Drug: NOX-E36

Drug: Placebo

Primary Outcome(s)

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

Secondary Outcome(s)

Pharmacodynamic profile [Time Frame: throughout the entire study]

Pharmacokinetic parameters in plasma and urine [Time Frame: throughout the entire study]

Secondary ID(s)

SNOXE36C001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors