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

NCT ID: NCT06270030

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-04
• Study Completion Date: 2024-04-10

Brief Summary

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

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

Conditions

Presbyopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

LNZ101 (Aceclidine /Brimonidine) ophthalmic solution

Drug: Aceclidine/Brimonidine ophthalmic solution Other Names: LNZ101

Group Type: EXPERIMENTAL

LNZ101 (Aceclidine /Brimonidine) ophthalmic solution

Intervention Type: 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: Aceclidine ophthalmic solution Other Names: LNZ100

Group Type: EXPERIMENTAL

LNZ100 (Aceclidine) ophthalmic solution

Intervention Type: 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: Placebo (Vehicle) ophthalmic solution Other Names: NA

Group Type: PLACEBO_COMPARATOR

Placebo (Vehicle) ophthalmic solution

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

LENZ Therapeutics, Inc

OTHER

Sponsor Role: collaborator

Corxel Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Larry Li, Doctor

Role: STUDY_DIRECTOR

Corxel Pharmaceuticals

Locations

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

CTR20240460

Identifier Type: OTHER

Identifier Source: secondary_id

JX07002

Identifier Type: -

Identifier Source: org_study_id