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| Name | Class |
|---|---|
| ORA, Inc. | INDUSTRY |
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This is a single-center, open-label, randomized study to assess the plasma pharmacokinetic profile of LNZ101 and LNZ100.
To characterize the plasma pharmacokinetics and safety profile of LNZ101 and LNZ100 ophthalmic solutions in both eyes once a day for 8 days in healthy volunteers with presbyopia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LNZ101 | Other | Aceclidine 1.75% / Brimonidine combination (non-preserved) ophthalmic solution |
|
| LNZ100 | Other | Aceclidine 1.75% (non-preserved) ophthalmic solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aceclidine + Brimonidine | Drug | LNZ101 (Aceclidine/Brimonidine) non-preserved ophthalmic solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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-inf | 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety: adverse event reporting | The number of patients who experience one or more TEAE during the treatment period | up to 37 days |
Inclusion Criteria:
Each subject must:
Exclusion Criteria:
Each subject must not:
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| Name | Affiliation | Role |
|---|---|---|
| Kris Gameblin | LENZ Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site #101 | Newport Beach | California | 92663 | United States |
there is no plan.
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A Prospective, Single-Center, Open-Label, Study of the Plasma Pharmacokinetics
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this is an open label study.
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| Aceclidine |
| Drug |
LNZ100 (Aceclidine) non-preserved ophthalmic solution |
|
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D011305 | Presbyopia |
| D012030 | Refractive Errors |
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| ID | Term |
|---|---|
| C084650 | aceclidine |
| D000068438 | Brimonidine Tartrate |
| ID | Term |
|---|---|
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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