Plasma Pharmacokinetics and Safety of LNZ101 and LNZ100 Ophthalmic Solutions in Healthy Adult Subjects With Presbyopia

Completed · Phase 1

Conditions studied: Eye Diseases, Presbyopia, Refractive Errors, Brimonidine Tartrate, Aceclidine, Ophthalmic Solutions

In brief

This is a single-center, open-label, randomized study to assess the plasma pharmacokinetic profile of LNZ101 and LNZ100.

Key facts

Study ID

NCT05936489

Run by

LENZ Therapeutics, Inc

People needed

30

Starts

2023-07-06

Expected to finish

2023-10-03

Last updated by the study team

2023-10-16

Who can join

Age: 45 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Each subject must:
• Be able and willing to provide written informed consent and sign a Health Information Portability and Accountability Act (HIPAA) form prior to any study procedure being performed;
• Be able and willing to follow all instructions and attend all study visits;
• Be 45-75 years of age of either sex and any race or ethnicity;
• Be presbyopic in both eyes;

You may not qualify if…

• Each subject must not:
• Have known contraindications or sensitivity to the use of the investigational drug or its components, or any other medications required by the protocol;
• Have any active systemic or ocular disorder other than refractive disorder;
• Have prior, current or anticipated use of any contact lenses during study participation;
• Have presence of any abnormality of the lids, ocular surface, or lacrimal duct system that could affect ophthalmic drop absorption;
• Have anticipated inability to stay confined on required study days;

Where it is running

• Site #101 — Newport Beach, California, United States

Full record on ClinicalTrials.gov

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