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

Ji Xing Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Presbyopia

Treatments: Drug: LNZ100 (Aceclidine) ophthalmic solution; Drug: LNZ101 (Aceclidine /Brimonidine) ophthalmic solution; Drug: Placebo (Vehicle) ophthalmic solution

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06270030

CTR20240460 (Other Identifier)

JX07002

Details and patient eligibility

About

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

Full 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

Enrollment: 21 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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21 participants in 3 patient groups, including a placebo group

LNZ101 (Aceclidine /Brimonidine) ophthalmic solution

Experimental group

Description:

Drug: Aceclidine/Brimonidine ophthalmic solution Other Names: LNZ101

Treatment:

Drug: LNZ101 (Aceclidine /Brimonidine) ophthalmic solution

LNZ100 (Aceclidine) ophthalmic solution

Experimental group

Description:

Drug: Aceclidine ophthalmic solution Other Names: LNZ100

Treatment:

Drug: LNZ100 (Aceclidine) ophthalmic solution

Placebo (Vehicle) ophthalmic solution

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo (Vehicle) ophthalmic solution