NOX-A12 First-in-human (FIH) Study

NCT00976378 | Completed Phase 1

• 1 other identifier: SNOXA12C001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This is the first time NOX-A12 will be administered to man. The principal aim of this study is to obtain safety and tolerability data when NOX-A12 is administered by single intravenous (IV) doses to healthy male and female subjects. This information, together with the pharmacokinetic and pharmacodynamic data, will help establish the doses and dosage regimen of administration suitable for subsequent studies in the patient population.

Conditions

Autologous Stem Cell Transplantation

Keywords

stromal cell-derived factor-1 (SDF-1); L-oligonucleotide aptamer; Spiegelmer

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of NOX-A12 by means of adverse events, vital signs, laboratory parameters, 12-lead ECG and immunogenicity assessment

  1 month

Secondary Outcomes (2)

• Pharmacokinetic parameters in plasma and urine

  1 month

• Pharmacodynamic profile

  1 month

Study Arms (8)

0.05 mg/kg NOX-A12

EXPERIMENTAL

Drug: NOX-A12

0.15 mg/kg NOX-A12

EXPERIMENTAL

Drug: NOX-A12

0.45 mg/kg NOX-A12

EXPERIMENTAL

Drug: NOX-A12

1.35 mg/kg NOX-A12

EXPERIMENTAL

Drug: NOX-A12

2.7 mg/kg NOX-A12

EXPERIMENTAL

Drug: NOX-A12

5.4 mg/kg NOX-A12

EXPERIMENTAL

Drug: NOX-A12

10.8 mg/kg NOX-A12

EXPERIMENTAL

Drug: NOX-A12

5.4 mg/kg NOX-A12 plus apheresis

EXPERIMENTAL

Drug: NOX-A12

Interventions

NOX-A12 DRUG

single ascending IV doses, ranging from 0.05 mg/kg to 10.8 mg/kg

Also known as: olaptesed pegol

0.05 mg/kg NOX-A12; 0.15 mg/kg NOX-A12; 0.45 mg/kg NOX-A12; 1.35 mg/kg NOX-A12; 10.8 mg/kg NOX-A12; 2.7 mg/kg NOX-A12; 5.4 mg/kg NOX-A12

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Informed consent signed by the subject.
• Healthy subjects aged 18 to 60 years of any ethnic origin.
• Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, laboratory tests and electrocardiogram. Values out of reference range have to be assessed as not clinically significant (NCS) or clinically significant (CS) by an investigator. Individuals presenting deviating values assessed as NCS may be included.
• Subjects willing to use contraceptive methods from the time of dosing until 3 months after the final examination (such as condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository), females must be of non-child bearing potential. Non-child bearing potential is defined as follows: Female subjects 50 years of age or less must be surgically sterile or post-menopausal (defined as at least two years post cessation of menses and follicular stimulating hormone ≥35 mIU/mL and serum estradiol ≤25 pg/mL), non-lactating and have a negative pregnancy test. Female subjects 51 years of age or older must be surgically sterile or post-menopausal (defined by a value of follicular stimulating hormone ≥35 mIU/mL, serum estradiol ≤25 pg/mL or no spontaneous menstruation for at least one year before the first dose), non-lactating and have a negative pregnancy test.
• Body weight in defined relation to height. Body mass index 19 - 29 kg/m2 (extremes included).
• Calculated creatinine clearance ≥80 mL/min.
• Normal lung function (FVC and FEV1 at least 80% of predicted values) at screening.
• O2 saturation between 96% and 100% (extremes included) at screening.
• Body weight between 50 and 100 kg (extremes included).
• The subject is co-operative and available for the entire study.

You may not qualify if:

• Evidence in the subject's medical history or in the medical examination of any clinically significant hepatic, renal, gastrointestinal, cardiovascular, pulmonary, hematological or other significant acute or chronic abnormalities which might influence either the safety of the subject or the absorption, distribution, metabolism or excretion of the active agent under investigation.
• History of general malignant diseases.
• History of renal calculus.
• Hypersensitivity to drugs, atopic eczema, allergic bronchial asthma or any clinically significant allergic disease (excluding non-active hayfever).
• Intake of vitamin A derivatives or retinoids within 30 days prior to the start of the study as stated by the subject at screening.
• Subjects who have a significant history of sensitivity to natural sunlight or artificial light such as ultraviolet (UV) light from sunbeds.
• History of thrombosis.
• Laboratory test results outside the reference values as laid down by the study center, which may be an evidence of disease. Positive result of HIV1/2, HCV antibody or HBs antigen testing.
• Subjects who have an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risk of participating in the study, such as QTcB interval \>450 msec (females) and \>430 msec (males), 2nd or 3rd degree atrioventricular block, complete left bundle branch block, complete right bundle branch block or Wolff-Parkinson-White Syndrome, defined as PR\<110 msec, confirmed by a repeat ECG.
• Subjects who have had a clinically significant illness within 4 weeks of the start of dose administration as determined by the Investigator.
• History of relevant heart disorders or evidence of hyper- or hypotension (supine blood pressure systolic \>140 mmHg or \<95 mmHg or diastolic \>90 mmHg or \<65 mmHg at screening).
• Bradycardia or Bradyarrhythmia (pulse rate after 3 minutes supine rest \<45/min at screening).
• Tachycardia or Tachyarrhythmia (pulse rate after 3 minutes supine rest \>90/min at screening).
• Acute infection or fever within the last 4 weeks as stated by the subject at screening.
• Subjects who have received any prescribed systemic or topical medication within 14 days prior to dose administration as stated by the subject at screening, unless the medication will not interfere with the study procedures or compromise safety as assessed by an investigator.

Sponsors & Collaborators

• TME Pharma AG: lead
• German Federal Ministry of Education and Research: collaborator

Study Sites (1)

Scope Life Sciences GmbH

Hamburg, Germany

Location

Related Publications (1)

• Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.

  PMID: 30957581 DERIVED

MeSH Terms

Interventions

NOX-A12

Study Officials

• Stefan Zeitler, MD

  TME Pharma AG

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2009
• First Posted: September 14, 2009
• Study Start: October 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: June 26, 2014

Record last verified: 2013-05

Locations

DE (1)