Study of ESBA105 Eye Drops in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00671619
Recruitment Status : Completed
First Posted : May 5, 2008
Last Update Posted : August 25, 2008
Information provided by:

Brief Summary:


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 or disease Intervention/treatment Phase
Healthy Drug: ESBA105 Phase 1

Detailed Description:
ESBA105 is an anti TNF single chain antibody fragment

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, 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
Study Start Date : April 2008
Actual Primary Completion Date : July 2008
Actual Study Completion Date : August 2008

Intervention Details:
  • Drug: ESBA105
    eye drops

Primary Outcome Measures :
  1. safety and tolerability [ Time Frame: several timepoints ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00671619

Swiss Pharma Contract
Basel, Switzerland
Sponsors and Collaborators

Responsible Party: Peter Lichtlen, Medical Director, ESBATech AG Identifier: NCT00671619     History of Changes
Other Study ID Numbers: ESBA105CRD01
First Posted: May 5, 2008    Key Record Dates
Last Update Posted: August 25, 2008
Last Verified: August 2008

Keywords provided by ESBATech AG:
antibody fragment
TNF alpha

Additional relevant MeSH terms:
Ophthalmic Solutions
Pharmaceutical Solutions