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

NCT06270030 | Completed Phase 1

• 2 other identifiers: JX07002CTR20240460
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Conditions

Presbyopia

Keywords

Presbyopia; LNZ100; LNZ101

Outcome Measures

Primary Outcomes (6)

• 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

• AUC0-∞

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

  Day 1 and Day 8

• T1/2

  Terminal half-life 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

Study Arms (3)

LNZ101 (Aceclidine /Brimonidine) ophthalmic solution

EXPERIMENTAL

Drug: Aceclidine/Brimonidine ophthalmic solution Other Names: LNZ101

Drug: LNZ101 (Aceclidine /Brimonidine) ophthalmic solution

LNZ100 (Aceclidine) ophthalmic solution

EXPERIMENTAL

Drug: Aceclidine ophthalmic solution Other Names: LNZ100

Drug: LNZ100 (Aceclidine) ophthalmic solution

Placebo (Vehicle) ophthalmic solution

PLACEBO COMPARATOR

Drug: Placebo (Vehicle) ophthalmic solution Other Names: NA

Drug: Placebo (Vehicle) ophthalmic solution

Interventions

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

LNZ101 (Aceclidine /Brimonidine) ophthalmic solution

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

LNZ100 (Aceclidine) ophthalmic solution

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

Placebo (Vehicle) ophthalmic solution

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corxel Pharmaceuticals: lead
• LENZ Therapeutics, Inc: collaborator

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

MeSH Terms

Conditions

Presbyopia

Interventions

aceclidine; Brimonidine Tartrate; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Larry Li, Doctor

  Corxel Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 21, 2024
• Study Start: March 4, 2024
• Primary Completion: April 10, 2024
• Study Completion: April 10, 2024
• Last Updated: April 23, 2024

Record last verified: 2024-04

Locations

CN (1)