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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00976729
• Other study ID #: SNOXE36C001
• Status: Completed
• Phase: Phase 1
• First received: September 11, 2009
• Last updated: February 12, 2013
• Start date: May 2009
• Est. completion date: December 2009

Study information

• Verified date: February 2013
• Source: NOXXON Pharma AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• NOX-E36
single ascending IV doses, ranging from 0.03 mg/kg to 2.0 mg/kg
• NOX-E36
single SC doses, at safe and tolerable dose level
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NOXXON Pharma AG

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Pharmacokinetic parameters in plasma and urine		throughout the entire study	No
Secondary	Pharmacodynamic profile		throughout the entire study	No