Safety and Tolerability of MRZ-99030 Eye Drops in Healthy Volunteers and Glaucoma Patients

Merz Pharmaceuticals GmbH70 enrolled

Overview

* To assess the safety and tolerability of repeat dose topical administration of MRZ-99030 Ophthalmic Solution with ascending doses in healthy subjects (stage 1) and glaucoma subjects (stage 2). * To assess plasma pharmacokinetics and urine concentration of MRZ- 99030 and its metabolite MRZ-9499 after single and repeat dose topical administration of MRZ-99030 Ophthalmic Solution.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Healthy Volunteers and Glaucoma Patients

Interventions

MRZ-99030 eye drops 5mg/mLDRUG

MRZ-99030 eye drops 20mg/mLDRUG

Placebo to MRZ-99030 eye dropsDRUG

Eligibility

Sex: ALLMin age: 35 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: For stage 1: \- Healthy volunteers For stage 2: \- Glaucoma patients Exclusion Criteria: For stage 2: \- Any relevant eye disease other than glaucoma

Locations (1)

Parexel International GmbH, Early Phase Clinical Unit

Berlin, Germany

Outcomes

Primary Outcomes

Incidence of adverse events

Time frame: Day 1 up to day 23

Secondary Outcomes

Area under the curve (AUC)

Time frame: Day 1 to day 17

Maximal plasma concentration (Cmax)

Time frame: Day 1 to day 17

Data from ClinicalTrials.gov

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