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

Presbyopia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05936489
• Other study ID #: 22-100-0007
• Status: Completed
• Phase: Phase 1
• Start date: July 6, 2023
• Est. completion date: October 3, 2023

Study information

• Verified date: October 2023
• Source: LENZ Therapeutics, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 3, 2023
• Est. primary completion date: October 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Brimonidine Tartrate
• Eye Diseases
• Ophthalmic Solutions
• Presbyopia
• Refractive Errors

Intervention

Drug:
• Aceclidine + Brimonidine
LNZ101 (Aceclidine/Brimonidine) non-preserved ophthalmic solution
• Aceclidine
LNZ100 (Aceclidine) non-preserved ophthalmic solution

Locations

Country	Name	City	State
United States	Site #101	Newport Beach	California

Sponsors (2)

Lead Sponsor	Collaborator
LENZ Therapeutics, Inc	ORA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety: adverse event reporting	The number of patients who experience one or more TEAE during the treatment period	up to 37 days
Primary	Cmax	Maximum plasma concentrations of LNZ100 and LNZ101	Day 1 and Day 8
Primary	Tmax	Time of maximum plasma concentrations of LNZ100 and LNZ101	Day 1 and Day 8
Primary	AUC0-t	Area under the concentration-time curve from time 0 to time t of LNZ100 and LNZ100	Day 1 and Day 8
Primary	AUC0-inf	Area under the concentration-time curve from time 0 to infinity of LNZ100 and LNZ101	Day 1 and Day 8
Primary	T1/2	Terminal half-life of LNZ100 and LNZ101	Day 1 and Day 8