Presbyopia
Conditions
Keywords
Presbyopia, LNZ100, LNZ101
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
Interventions
DRUGLNZ101 (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
DRUGLNZ100 (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
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
Sponsors
LENZ Therapeutics, Inc
Corxel Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | Day 1 and Day 8 | Maximum plasma concentrations of LNZ100 and LNZ101 |
| Tmax | Day 1 and Day 8 | Time of maximum plasma concentrations of LNZ100 and LNZ101 |
| AUC0-t | Day 1 and Day 8 | Area under the concentration-time curve from time 0 to time t of LNZ100 and LNZ100 |
| AUC0-∞ | Day 1 and Day 8 | Area under the concentration-time curve from time 0 to infinity of LNZ100 and LNZ101 |
| T1/2 | Day 1 and Day 8 | Terminal half-life of LNZ100 and LNZ101 |
| Safety: adverse event reporting | up to 23 days | The number of patients who experience one or more AE during the treatment period |
Countries
China
Outcome results
None listed