NCT01372137

Brief Summary

This is the first clinical trial with NOX-H94. The purpose of this clinical trial is to identify a safe and efficacious treatment regimen for the clinical development of NOX-H94 in patients with anemia of chronic disease (inflammation).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 13, 2011

Completed
18 days until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

January 25, 2016

Status Verified

June 1, 2014

Enrollment Period

8 months

First QC Date

June 8, 2011

Last Update Submit

January 22, 2016

Conditions

AnemiaChronic DiseasesInflammation

Keywords

NOX-H94HepcidinAnemiaInflammation

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events

    0 to 90 days

Secondary Outcomes (1)

  • drug plasma concentrations

    0 to 29 days

Study Arms (2)

NOX-H94

EXPERIMENTAL

Group A: single 15 minutes IV infusion of 0.3 mg/kg NOX-H94 Group B: single 15 minutes IV infusion of 0.6 mg/kg NOX-H94 Group C: single 15 minutes IV infusion of 1.2 mg/kg NOX-H94 Group D: single 15 minutes IV infusion of 2.4 mg/kg NOX-H94 Group E: single 15 minutes IV infusion of 4.8 mg/kg NOX-H94 Group F: single / repeated SC injection of NOX-H94 over a treatment period of 2 weeks Group G: multiple doses of NOX-H94 as a 15 minutes IV infusion over a treatment period of 2 weeks Group H: multiple doses of NOX-H94 as a 15 minutes IV infusion over a treatment period of 2 weeks

Drug: NOX-H94

Glucose 5%

PLACEBO COMPARATOR

Group A to Group H get NOX-H94 or Placebo

Other: Glucose 5%

Interventions

NOX-H94DRUG

Dosage form: NOX-H94 25 mg (oligonucleotide basis) Solution for Injection Strength: 14.6 mg NOX-H94 / mL Dose: 0.3 - 4.8 mg/kg single dose Route: IV infusion over 15 minutes / SC administration

Also known as: lexaptepid pegol
NOX-H94
Glucose 5%OTHER

Placebo

Glucose 5%

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male subjects or female subjects of non-childbearing potential (Groups A to E), male subjects (groups F to H)
  • Age 18-65 years
  • Healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram, and clinical laboratory parameters
  • Males willing to use 2 means of contraceptive methods for at least 2 months after the final examination

You may not qualify if:

  • Anemia predominantly caused by other factors than chronic disease.
  • Iron overload or disturbances in utilization of iron.
  • Intravenous iron treatment or blood transfusion within 4 weeks prior to screening visit.
  • Erythropoietin treatment within 4 weeks prior to screening visit.
  • Intake of Intravenous iron, Blood transfusions, Erythropoietin during their trial participation.
  • Resting supine pulse rate \< 40 or \> 100 beats / min.
  • Resting supine blood pressure:
  • Systolic blood pressure \< 90 or \> 160 mmHg Diastolic blood pressure \< 40 or \> 100 mmHg.
  • History or presence of confirmed orthostatic hypotension defined.
  • Positive test of HIV type 1/2 antibodies, HBs antigen, HBc antibodies, HCV antibodies.
  • Participation in another clinical trial during the last 3 months before starting this trial.
  • Positive test for drugs of abuse.
  • Diseases or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
  • Marked repolarization abnormality.
  • Current bronchial asthma, childhood asthma which has been resolved is allowed.
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HMR

London, NW10 7EW, United Kingdom

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: 30957581DERIVED

MeSH Terms

Conditions

AnemiaChronic DiseaseInflammation

Interventions

NOX-H94

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Riecke Kai, MD

    TME Pharma AG

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2011

First Posted

June 13, 2011

Study Start

July 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

January 25, 2016

Record last verified: 2014-06

Locations

GB(1)