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Study of ESBA105 Eye Drops in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
ESBATech AG
ClinicalTrials.gov Identifier:
NCT00671619
First received: April 28, 2008
Last updated: August 22, 2008
Last verified: August 2008
History of Changes
  Purpose

Objectives:

To evaluate the safety, tolerability and pharmacokinetics of ESBA105 administered topically to the eye for up to 28 days in healthy volunteers.

To determine the systemic exposure to ESBA105 upon single and repeated-dose topical application to the eye in healthy volunteers.


Condition Intervention Phase
Healthy
 Drug: ESBA105
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase I, Randomized, Vehicle-Controlled, Double-Blind, Mono-Centric, Single and Repeated Dose, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ESBA105 Eye Drops in Healthy Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by ESBATech AG:

Primary Outcome Measures:
  • safety and tolerability [ Time Frame: several timepoints ] [ Designated as safety issue: Yes ]

Enrollment: 27
Study Start Date: April 2008
Study Completion Date: August 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: ESBA105
    eye drops
Detailed Description:

ESBA105 is an anti TNF single chain antibody fragment

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female Caucasian subjects.
  • Written informed consent prior to any study procedures including screening tests for eligibility.
  • Subjects should be in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
  • Normal sitting blood pressure and pulse rate, i.e.: BP: 100-160 mm Hg systolic, 50-90 mm Hg diastolic and pulse rate: 45-100 bpm. Blood pressure and pulse will be measured after 3 minutes resting in a sitting position.
  • Bilateral corrected visual acuity of at least 0.9
  • No need for regular concomitant medication.
  • Ability to communicate well with the investigator and comply with the requirements of the entire study.
  • Use of qualified contraception

Exclusion Criteria:

  • Any evidence of infectious disease as evidenced by medical history, clinical examination, positive serology results which indicate the presence of hepatitis B and/ or C or HIV infection or positive results of the QuantiFERON TB Gold test based latent tuberculosis testing.
  • History of serious adverse reactions or hypersensitivity to any drug.
  • Presence or history of any allergy including allergic conjunctivitis requiring acute or chronic treatment (seasonal allergic rhinitis not associated to conjunctivitis which requires no treatment may be tolerated).
  • Abnormal physical findings of clinical significance at the screening examination or baseline which would interfere with the objectives of the study.
  • Existence of any surgical or medical condition which might interfere with the evaluation of the general drug safety and tolerability including clinically relevant ophthalmological diseases, impaired renal or hepatic function, diabetes mellitus, cardiovascular abnormalities, haematological abnormalities, psychiatric diseases, chronic symptoms of pronounced constipation or diarrhoea or conditions associated with total or partial obstruction of the urinary tract.
  • Shallow anterior chamber, closed angle glaucoma or any other contraindication to eye dilation for ophthalmological examination.
  • History or presence of any other clinically relevant (in the opinion of the Investigator) ocular disease.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00671619

Locations
Switzerland
Swiss Pharma Contract
Basel, Switzerland
Sponsors and Collaborators
ESBATech AG
  More Information

No publications provided

Responsible Party: Peter Lichtlen, Medical Director, ESBATech AG
ClinicalTrials.gov Identifier: NCT00671619     History of Changes
Other Study ID Numbers: ESBA105CRD01
Study First Received: April 28, 2008
Last Updated: August 22, 2008
Health Authority: Switzerland: Swissmedic

Keywords provided by ESBATech AG:
opthalmology
antibody fragment
TNF alpha

Additional relevant MeSH terms:
Tetrahydrozoline
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
 Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013