First-in-Human Study of LHA510 in Elderly Subjects and Patients With Age-Related Macular Degeneration

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this first-in-human study is to assess the local ocular and systemic safety and tolerability of LHA510 eye drops when administered at various concentrations and dosing frequencies.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alcon Research
• Treatments: Acrizanib

Criteria

Inclusion Criteria:

• Provide written informed consent.

• Vital signs within the following ranges:

• oral body temperature between 35.0-37.5 °C

• systolic blood pressure, 90-150 mm Hg

• diastolic blood pressure, 50-90 mm Hg

• pulse rate, 40 - 100 bpm.

• Weigh at least 50 kg.

• Able to communicate well with the investigator.

• Able to understand and comply with the requirements of the study.

Additional eligibility criteria for Part 2 (AMD subjects):

• Evidence of AMD in one or both eyes.

• Age 55-90.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Any currently active ocular condition that requires use of topical eye drops.

• Use of contact lens over the course of the study.

• Abnormal corneal examination results at screening or eligibility.

• History of any ocular surgery within the past 6 months prior to study participation.

• Use of other investigational drugs within 30 days of enrollment.

• History of hypersensitivity or allergy to any of the study drugs (including fluorescein) or to drugs of similar chemical classes.

• History of clinically significant ECG abnormalities, or any ECG abnormality at screening or eligibility.

• Known history or current clinically significant arrhythmias.

• History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years.

• Pregnant or nursing (lactating) women.

• Women of child-bearing potential.

• Use of any prohibited medication as specified in the protocol.

• Donation or loss of 400 ml or more of blood within eight (8) weeks prior to initial dosing.

• Low hemoglobin levels at screening or eligibility as specified in the protocol.

• Significant illness as specified in the protocol.

• History of drug or alcohol abuse within the 12 months prior to dosing.

Additional exclusion criteria for Part 1 (healthy subjects):

• Abnormal thickness of the central retinal subfield on OCT at screening.

• History of any chronic eye disease other than refractive error, incipient cataract, strabismic amblyopia, or anisometropic amblyopia.

Additional exclusion criteria for Part 2 (AMD subjects):

• Any of the following treatments to the study eye within 28 days prior to dosing:

ranibizumab (Lucentis®), aflibercept (Eylea®), bevacizumab (Avastin®), pegaptanib (Macugen®), or any other VEGF inhibitor.

• Patients who have required and received regular monthly injections of these drugs in the months preceding the study.