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

Presbyopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06270030
• Other study ID #: JX07002
• Secondary ID: CTR20240460
• Status: Completed
• Phase: Phase 1
• Start date: March 4, 2024
• Est. completion date: April 10, 2024

Study information

• Verified date: April 2024
• Source: Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: April 10, 2024
• Est. primary completion date: April 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Presbyopia

Intervention

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
• 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 (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

Locations

Country	Name	City	State
China	Shanghai General Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.	LENZ Therapeutics, Inc

Country where clinical trial is conducted

China, 

Outcome

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