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

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: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Drug: LNZ101 (Aceclidine /Brimonidine) ophthalmic solution; Drug: LNZ100 (Aceclidine) ophthalmic solution; Drug: Placebo (Vehicle) ophthalmic solution

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: Interventional
• Enrollment (Actual): 21
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum plasma concentrations of LNZ100 and LNZ101	Day 1 and Day 8
Tmax	Time of maximum plasma concentrations of LNZ100 and LNZ101	Day 1 and Day 8
AUC0-t	Area under the concentration-time curve from time 0 to time t of LNZ100 and LNZ100	Day 1 and Day 8
T1/2	Terminal half-life of LNZ100 and LNZ101	Day 1 and Day 8
AUC0-∞	Area under the concentration-time curve from time 0 to infinity of LNZ100 and LNZ101	Day 1 and Day 8
Safety: adverse event reporting	The number of patients who experience one or more AE during the treatment period	up to 23 days

Collaborators and Investigators

• Sponsor: Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.
• Collaborators: LENZ Therapeutics, Inc
• Investigators: Study Director: Larry Li, Doctor, Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2024
• Primary Completion (Actual): April 10, 2024
• Study Completion (Actual): April 10, 2024

Study Registration Dates

• First Submitted: February 6, 2024
• First Submitted That Met QC Criteria: February 17, 2024
• First Posted (Actual): February 21, 2024

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Presbyopia; LNZ100; LNZ101
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Miotics; Parasympathomimetics; Brimonidine Tartrate; Ophthalmic Solutions; Pharmaceutical Solutions; Aceclidine
• Other Study ID 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