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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00976729

Enrollment

Registered

2009-09-14

Start date

2009-05-31

Completion date

2009-12-31

Last updated

2013-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

monocyte chemoattractant protein-1 (MCP-1), L-oligonucleotide aptamer, Spiegelmer

Brief 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.

Interventions

DRUGNOX-E36

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

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Measure	Time frame
Pharmacokinetic parameters in plasma and urine	throughout the entire study
Pharmacodynamic profile	throughout the entire study

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026