Skip to main content
OpenTrials
Completed

NCT Number: NCT06270030

Safety, Tolerability and Pharmacokinetics of LNZ101 and LNZ100 Ophthalmic Solutions in Healthy Adult Chinese With Presbyopia

Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LNZ101 and LNZ100 Ophthalmic Solutions in Chinese Healthy Adult Subjects with Presbyopia

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Presbyopia Eye Diseases Refractive Errors

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

About this study

A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LNZ101 and LNZ100 Ophthalmic Solutions in Chinese Healthy Adult Subjects with Presbyopia

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Be able and willing to provide written informed consent prior to any study procedure being performed.
  • Be able to and willing to use investigational products per study requirements and attend all study assessments, including admission to and stay in the CRU on required study days.
  • Be Chinese healthy male or female subjects aged 45-75 years (inclusive) at screening.
  • Be diagnosed and documented to have presbyopia by the investigator at the screening visit.

Exclusion criteria

  • Have known contraindications or sensitivity to the use of any of the investigational products or its components, or any other medications required by the protocol.
  • Have any active systemic or ocular disorder that has a potential risk to or impact on subject safety, study process or study results other than refractive disorder.
  • Have presence of any abnormality of the lids, ocular surface, or lacrimal duct system that in the investigator's opinion could affect ophthalmic solution absorption in either eye.
  • Have prior (within 14 days of the first dose), current or anticipated use of any contact lenses during study participation.
  • Be ineligible for this trial in the opinion of the investigator.

Treatment and study plan

LNZ101 (Aceclidine /Brimonidine) ophthalmic solution

Drug

Once daily from day 1 to day 8; Everyday, subject will be administered with 1 drop in each eye followed by another drop in each eye 2 minutes later

LNZ100 (Aceclidine) ophthalmic solution

Drug

Once daily from day 1 to day 8; Everyday, subject will be administered with 1 drop in each eye followed by another drop in each eye 2 minutes later

Placebo (Vehicle) ophthalmic solution

Drug

Once daily from day 1 to day 8; Everyday, subject will be administered with 1 drop in each eye followed by another drop in each eye 2 minutes later

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-∞

    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

  6. Safety: adverse event reporting

    Time frame: up to 23 days

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

Sponsors and collaborators

Lead sponsor

Corxel Pharmaceuticals

Industry

Collaborators

  • LENZ Therapeutics, Inc

Registry information

Official study title

A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LNZ101 and LNZ100 Ophthalmic Solutions in Chinese Healthy Adult Subjects With Presbyopia

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 21, 2024
Registry last updated
Apr 23, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.