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

Primary Purpose

Eye Diseases, Presbyopia, Refractive Errors

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Aceclidine + Brimonidine
Aceclidine
Sponsored by
LENZ Therapeutics, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eye Diseases

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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; Exclusion Criteria: 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;

Sites / Locations

  • Site #101

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

LNZ101

LNZ100

Arm Description

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

Aceclidine 1.75% (non-preserved) ophthalmic solution

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 21, 2023
Last Updated
October 12, 2023
Sponsor
LENZ Therapeutics, Inc
Collaborators
ORA, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05936489
Brief Title
Plasma Pharmacokinetics and Safety of LNZ101 and LNZ100 Ophthalmic Solutions in Healthy Adult Subjects With Presbyopia
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
July 6, 2023 (Actual)
Primary Completion Date
October 3, 2023 (Actual)
Study Completion Date
October 3, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LENZ Therapeutics, Inc
Collaborators
ORA, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eye Diseases, Presbyopia, Refractive Errors, Brimonidine Tartrate, Aceclidine, Ophthalmic Solutions

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
A Prospective, Single-Center, Open-Label, Study of the Plasma Pharmacokinetics
Masking
None (Open Label)
Masking Description
this is an open label study.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LNZ101
Arm Type
Other
Arm Description
Aceclidine 1.75% / Brimonidine combination (non-preserved) ophthalmic solution
Arm Title
LNZ100
Arm Type
Other
Arm Description
Aceclidine 1.75% (non-preserved) ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
Aceclidine + Brimonidine
Intervention Description
LNZ101 (Aceclidine/Brimonidine) non-preserved ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
Aceclidine
Intervention Description
LNZ100 (Aceclidine) non-preserved ophthalmic solution
Primary Outcome Measure Information:
Title
Cmax
Description
Maximum plasma concentrations of LNZ100 and LNZ101
Time Frame
Day 1 and Day 8
Title
Tmax
Description
Time of maximum plasma concentrations of LNZ100 and LNZ101
Time Frame
Day 1 and Day 8
Title
AUC0-t
Description
Area under the concentration-time curve from time 0 to time t of LNZ100 and LNZ100
Time Frame
Day 1 and Day 8
Title
AUC0-inf
Description
Area under the concentration-time curve from time 0 to infinity of LNZ100 and LNZ101
Time Frame
Day 1 and Day 8
Title
T1/2
Description
Terminal half-life of LNZ100 and LNZ101
Time Frame
Day 1 and Day 8
Other Pre-specified Outcome Measures:
Title
Safety: adverse event reporting
Description
The number of patients who experience one or more TEAE during the treatment period
Time Frame
up to 37 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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; Exclusion Criteria: 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kris Gameblin
Organizational Affiliation
LENZ Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Site #101
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
there is no plan.

Learn more about this trial

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

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