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

• Sponsor: LENZ Therapeutics, Inc (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05936489
• Collaborator: ORA, Inc. (Industry)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 4.8
• Patients Per Site Per Month: 6.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Eye Diseases; Presbyopia; Refractive Errors; Brimonidine Tartrate; Aceclidine; Ophthalmic Solutions	Drug: Aceclidine + Brimonidine; Drug: Aceclidine	Phase 1

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A Prospective, Single-Center, Open-Label, Study of the Plasma PharmacokineticsA Prospective, Single-Center, Open-Label, Study of the Plasma Pharmacokinetics
• Masking: None (Open Label)
• Masking Description: this is an open label study.
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jul 6, 2023
• Anticipated Primary Completion Date: Oct 2, 2023
• Anticipated Study Completion Date: Nov 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Cmax [Day 1 and Day 8]

   Maximum plasma concentrations of LNZ100 and LNZ101

2. Tmax [Day 1 and Day 8]

   Time of maximum plasma concentrations of LNZ100 and LNZ101

3. AUC0-t [Day 1 and Day 8]

   Area under the concentration-time curve from time 0 to time t of LNZ100 and LNZ100

4. AUC0-inf [Day 1 and Day 8]

   Area under the concentration-time curve from time 0 to infinity of LNZ100 and LNZ101

5. T1/2 [Day 1 and Day 8]

   Terminal half-life of LNZ100 and LNZ101

Other Outcome Measures

1. Safety: adverse event reporting [up to 37 days]

   The number of patients who experience one or more TEAE during the treatment period

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site #101	Newport Beach	California	United States	92663

Sponsors and Collaborators

• LENZ Therapeutics, Inc
• ORA, Inc.

Investigators

• Study Director: Kris Gameblin, LENZ Therapeutics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: LENZ Therapeutics, Inc
• ClinicalTrials.gov Identifier: NCT05936489
• Other Study ID Numbers: 22-100-0007
• First Posted: Jul 7, 2023
• Last Update Posted: Jul 10, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Eye Diseases; Presbyopia; Refractive Errors; Brimonidine Tartrate; Aceclidine

Study Results

No Results Posted as of Jul 10, 2023