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

NCT05936489 | Completed Phase 1 FDA Drug

• 1 other identifier: 22-100-0007
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Eye Diseases; Presbyopia; Refractive Errors; Brimonidine Tartrate; Aceclidine; Ophthalmic Solutions

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Safety: adverse event reporting

  up to 37 days

Study Arms (2)

LNZ101

OTHER

Aceclidine 1.75% / Brimonidine combination (non-preserved) ophthalmic solution

Drug: Aceclidine + Brimonidine

LNZ100

OTHER

Aceclidine 1.75% (non-preserved) ophthalmic solution

Drug: Aceclidine

Interventions

Aceclidine + Brimonidine DRUG

LNZ101 (Aceclidine/Brimonidine) non-preserved ophthalmic solution

LNZ101

Aceclidine DRUG

LNZ100 (Aceclidine) non-preserved ophthalmic solution

LNZ100

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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;

Sponsors & Collaborators

• LENZ Therapeutics, Inc: lead
• ORA, Inc.: collaborator

Study Sites (1)

Site #101

Newport Beach, California, 92663, United States

Location

MeSH Terms

Conditions

Eye Diseases; Presbyopia; Refractive Errors

Interventions

aceclidine; Brimonidine Tartrate

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Kris Gameblin

  LENZ Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: this is an open label study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A Prospective, Single-Center, Open-Label, Study of the Plasma Pharmacokinetics

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: July 7, 2023
• Study Start: July 6, 2023
• Primary Completion: October 3, 2023
• Study Completion: October 3, 2023
• Last Updated: October 16, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)