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

Phase 1

Completed

• Conditions: Ophthalmic Solutions; Presbyopia; Refractive Errors; Eye Diseases; Brimonidine Tartrate; Aceclidine
• Interventions: Drug: Aceclidine + Brimonidine; Drug: Aceclidine

• Registration Number: NCT05936489
• Lead Sponsor: LENZ Therapeutics, Inc

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-06-21
• Study First Submitted QC: 2023-06-30
• Study Start: 2023-07-06
• Study First Posted: 2023-07-07
• Status Verified: 2023-10
• Primary Completion: 2023-10-03
• Study Completion: 2023-10-03
• Last Update Submitted: 2023-10-12
• Last Update Posted: 2023-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LNZ101	Aceclidine + Brimonidine	Aceclidine 1.75% / Brimonidine combination (non-preserved) ophthalmic solution
LNZ100	Aceclidine	Aceclidine 1.75% (non-preserved) ophthalmic solution

Primary Outcome Measures

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

Trial Locations

Locations (1)

Site #101; 🇺🇸 Newport Beach, California, United States