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OpenTrials
Completed

NCT Number: NCT05936489

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

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

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Key information

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site #101

Newport Beach, California, 92663, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Aceclidine + Brimonidine

Drug

LNZ101 (Aceclidine/Brimonidine) non-preserved ophthalmic solution

Aceclidine

Drug

LNZ100 (Aceclidine) non-preserved ophthalmic solution

Primary outcomes

  1. Cmax

    Time frame: Day 1 and Day 8

    Maximum plasma concentrations of LNZ100 and LNZ101

  2. Tmax

    Time frame: Day 1 and Day 8

    Time of maximum plasma concentrations of LNZ100 and LNZ101

  3. AUC0-t

    Time frame: Day 1 and Day 8

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

  4. AUC0-inf

    Time frame: Day 1 and Day 8

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

  5. T1/2

    Time frame: Day 1 and Day 8

    Terminal half-life of LNZ100 and LNZ101

Other outcomes

  1. Safety: adverse event reporting

    Time frame: up to 37 days

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

Sponsors and collaborators

Lead sponsor

LENZ Therapeutics, Inc

Other

Collaborators

  • ORA, Inc.

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 7, 2023
Registry last updated
Oct 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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