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

• Status: Completed
• Trial end date: 2023-10-03
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: LENZ Therapeutics, Inc
• Collaborator: ORA, Inc.
• Treatments: Aceclidine; Brimonidine Tartrate

Criteria

Inclusion Criteria:

• Each subject must:

1. 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;

2. Be able and willing to follow all instructions and attend all study visits;

3. Be 45-75 years of age of either sex and any race or ethnicity;

4. Be presbyopic in both eyes;

Exclusion Criteria:

• Each subject must not:

1. Have known contraindications or sensitivity to the use of the investigational drug or its components, or any other medications required by the protocol;

2. Have any active systemic or ocular disorder other than refractive disorder;

3. Have prior, current or anticipated use of any contact lenses during study participation;

4. Have presence of any abnormality of the lids, ocular surface, or lacrimal duct system that could affect ophthalmic drop absorption;

5. Have anticipated inability to stay confined on required study days;