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

A Prospective, Single-Center, Open-Label, Study of the Plasma Pharmacokinetics and Safety Following Topical Administration of LNZ101 and LNZ100 Ophthalmic Solutions in Healthy Adult Subjects With Presbyopia

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

Study Overview

• Status: Completed
• Conditions: Eye Diseases; Refractive Errors; Presbyopia; Ophthalmic Solutions; Brimonidine Tartrate; Aceclidine
• Intervention / Treatment: Drug: Aceclidine + Brimonidine; Drug: Aceclidine

Detailed Description

To characterize the plasma pharmacokinetics and safety profile of LNZ101 and LNZ100 ophthalmic solutions in both eyes once a day for 8 days in healthy volunteers with presbyopia

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Newport Beach, California, United States, 92663
      • Site #101

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: LNZ101; Aceclidine 1.75% / Brimonidine combination (non-preserved) ophthalmic solution	Drug: Aceclidine + Brimonidine; LNZ101 (Aceclidine/Brimonidine) non-preserved ophthalmic solution
Other: LNZ100; Aceclidine 1.75% (non-preserved) ophthalmic solution	Drug: Aceclidine; LNZ100 (Aceclidine) non-preserved ophthalmic solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum plasma concentrations of LNZ100 and LNZ101	Day 1 and Day 8
Tmax	Time of maximum plasma concentrations of LNZ100 and LNZ101	Day 1 and Day 8
AUC0-t	Area under the concentration-time curve from time 0 to time t of LNZ100 and LNZ100	Day 1 and Day 8
AUC0-inf	Area under the concentration-time curve from time 0 to infinity of LNZ100 and LNZ101	Day 1 and Day 8
T1/2	Terminal half-life of LNZ100 and LNZ101	Day 1 and Day 8

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: adverse event reporting	The number of patients who experience one or more TEAE during the treatment period	up to 37 days

Collaborators and Investigators

• Sponsor: LENZ Therapeutics, Inc
• Collaborators: ORA, Inc.
• Investigators: Study Director: Kris Gameblin, LENZ Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2023
• Primary Completion (Actual): October 3, 2023
• Study Completion (Actual): October 3, 2023

Study Registration Dates

• First Submitted: June 21, 2023
• First Submitted That Met QC Criteria: June 30, 2023
• First Posted (Actual): July 7, 2023

Study Record Updates

• Last Update Posted (Actual): October 16, 2023
• Last Update Submitted That Met QC Criteria: October 12, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Refractive Errors; Eye Diseases; Presbyopia; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Miotics; Parasympathomimetics; Brimonidine Tartrate; Aceclidine
• Other Study ID Numbers: 22-100-0007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: there is no plan.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No