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

April 22, 2024 updated by: Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200080
        • Shanghai General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria

  1. Be able and willing to provide written informed consent prior to any study procedure being performed.
  2. 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.
  3. Be Chinese healthy male or female subjects aged 45-75 years (inclusive) at screening.
  4. Be diagnosed and documented to have presbyopia by the investigator at the screening visit.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. 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.
  4. Have prior (within 14 days of the first dose), current or anticipated use of any contact lenses during study participation.
  5. Be ineligible for this trial in the opinion of the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: LNZ101 (Aceclidine /Brimonidine) ophthalmic solution
Drug: Aceclidine/Brimonidine ophthalmic solution Other Names: LNZ101
Drug: LNZ101 (Aceclidine /Brimonidine) ophthalmic solution
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
Experimental: LNZ100 (Aceclidine) ophthalmic solution
Drug: Aceclidine ophthalmic solution Other Names: LNZ100
Drug: LNZ100 (Aceclidine) ophthalmic solution
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 Comparator: Placebo (Vehicle) ophthalmic solution
Drug: Placebo (Vehicle) ophthalmic solution Other Names: NA
Drug: Placebo (Vehicle) ophthalmic solution
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: Day 1 and Day 8
Maximum plasma concentrations of LNZ100 and LNZ101
Day 1 and Day 8
Tmax
Time Frame: Day 1 and Day 8
Time of maximum plasma concentrations of LNZ100 and LNZ101
Day 1 and Day 8
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
Day 1 and Day 8
T1/2
Time Frame: Day 1 and Day 8
Terminal half-life of LNZ100 and LNZ101
Day 1 and Day 8
AUC0-∞
Time Frame: Day 1 and Day 8
Area under the concentration-time curve from time 0 to infinity of LNZ100 and LNZ101
Day 1 and Day 8
Safety: adverse event reporting
Time Frame: up to 23 days
The number of patients who experience one or more AE during the treatment period
up to 23 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
LENZ Therapeutics, Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Larry Li, Doctor, Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 4, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 10, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 10, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JX07002
  • CTR20240460 (Other Identifier: China Center for Drug Evaluation (CDE), NMPA)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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