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

TME Pharma

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus; Chronic Inflammatory Diseases; Systemic Lupus Erythematosus

Treatments: Drug: NOX-E36; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00976729

SNOXE36C001

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 10 patient groups, including a placebo group

Placebo i.v.

Placebo Comparator group

Treatment:

Drug: Placebo

0.03 mg/kg i.v.

Experimental group

Treatment:

Drug: NOX-E36

Drug: NOX-E36

0.09 mg/kg i.v.

Experimental group

Treatment:

Drug: NOX-E36

Drug: NOX-E36

0.25 mg/kg i.v.

Experimental group

Treatment:

Drug: NOX-E36

Drug: NOX-E36

0.5 mg/kg i.v.

Experimental group

Treatment:

Drug: NOX-E36

Drug: NOX-E36

1.0 mg/kg i.v.

Experimental group

Treatment:

Drug: NOX-E36

Drug: NOX-E36

2.0 mg/kg i.v.

Experimental group

Treatment:

Drug: NOX-E36

Drug: NOX-E36

Placebo s.c.

Placebo Comparator group

Treatment:

Drug: Placebo

0.25 mg/kg s.c.

Experimental group

Treatment:

Drug: NOX-E36

Drug: NOX-E36

0.5 mg/kg s.c.

Experimental group

Treatment:

Drug: NOX-E36

Drug: NOX-E36