Eye DiseasesPhase 1NCT05936489
Plasma Pharmacokinetics and Safety of LNZ101 and LNZ100 Ophthalmic Solutions in Healthy Adult Subjects With Presbyopia
A Phase 1 study testing Aceclidine + Brimonidine and Aceclidine in people with Eye Diseases and Presbyopia, run by LENZ Therapeutics, Inc at 1 site in United States.
Trial summary
This is a single-center, open-label, randomized study to assess the plasma pharmacokinetic profile of LNZ101 and LNZ100. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Eye Diseases, Presbyopia, Refractive Errors
- What is being tested?
- Aceclidine + Brimonidine and Aceclidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2023to 3 Oct 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Each subject must:
- Be able and willing to provide written informed consent and sign a Health Information Portability and Accountability Act (HIPAA) form prior to any study procedure being performed;
- Be able and willing to follow all instructions and attend all study visits;
- Be 45-75 years of age of either sex and any race or ethnicity;
- Be presbyopic in both eyes;
Who cannot join
- Each subject must not:
- Have known contraindications or sensitivity to the use of the investigational drug or its components, or any other medications required by the protocol;
- Have any active systemic or ocular disorder other than refractive disorder;
- Have prior, current or anticipated use of any contact lenses during study participation;
- Have presence of any abnormality of the lids, ocular surface, or lacrimal duct system that could affect ophthalmic drop absorption;
- Have anticipated inability to stay confined on required study days;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Single-Center, Open-Label, Study of the Plasma Pharmacokinetics and Safety Following Topical Administration of LNZ101 and LNZ100 Ophthalmic Solutions in Healthy Adult Subjects With Presbyopia
This is a single-center, open-label, randomized study to assess the plasma pharmacokinetic profile of LNZ101 and LNZ100.
Read the detailed description
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
- Conditions
- Eye Diseases, Presbyopia, Refractive Errors, Brimonidine Tartrate, Aceclidine, Ophthalmic Solutions
- Being tested
- Aceclidine + Brimonidine, Aceclidine
- Medical subject headings
- Eye Diseases, Presbyopia, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aceclidine + BrimonidineDrug
LNZ101 (Aceclidine/Brimonidine) non-preserved ophthalmic solution
AceclidineDrug
LNZ100 (Aceclidine) non-preserved ophthalmic solution
| Study group | Role | What they receive |
|---|---|---|
| LNZ101 | Other | Aceclidine 1.75% / Brimonidine combination (non-preserved) ophthalmic solution Receives: Drug: Aceclidine + Brimonidine |
| LNZ100 | Other | Aceclidine 1.75% (non-preserved) ophthalmic solution Receives: Drug: Aceclidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum plasma concentrations of LNZ100 and LNZ101
Measured: Day 1 and Day 8
Tmax
Time of maximum plasma concentrations of LNZ100 and LNZ101
Measured: Day 1 and Day 8
AUC0-t
Area under the concentration-time curve from time 0 to time t of LNZ100 and LNZ100
Measured: Day 1 and Day 8
AUC0-inf
Area under the concentration-time curve from time 0 to infinity of LNZ100 and LNZ101
Measured: Day 1 and Day 8
T1/2
Terminal half-life of LNZ100 and LNZ101
Measured: Day 1 and Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start6 Jul 2023
- Primary completion3 Oct 2023
- Study completion3 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Prospective, Single-Center, Open-Label, Study of the Plasma Pharmacokinetics
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- LENZ Therapeutics, Inc
- Sponsor type
- University, hospital or other
- Collaborators
- ORA, Inc.
- Responsible party
- Sponsor
- Investigators
- Kris Gameblin, Study director, LENZ Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05936489
- Sponsor's protocol ID
- 22-100-0007
- Status last verified
- Oct 2023
- First submitted
- 21 Jun 2023
- Last updated
- 16 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: there is no plan.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Center, Open-Label, Study of the Plasma Pharmacokinetics and Safety Following Topical Administration of LNZ101 and LNZ100 Ophthalmic Solutions in Healthy Adult Subjects With Presbyopia
- ClinicalTrials.gov ID
- NCT05936489
- Acronym / sponsor ID
- 22-100-0007
- Conditions
- Eye Diseases, Presbyopia, Refractive Errors, Brimonidine Tartrate, Aceclidine, Ophthalmic Solutions
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- LENZ Therapeutics, IncUniversity, hospital or other
- Collaborators
- ORA, Inc.
- Study start
- 6 Jul 2023 (actual)
- Primary completion
- 3 Oct 2023 (actual)
- Study completion
- 3 Oct 2023 (actual)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, open-label, randomized study to assess the plasma pharmacokinetic profile of LNZ101 and LNZ100.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A Prospective, Single-Center, Open-Label, Study of the Plasma Pharmacokinetics
| Arm | Type | Receives |
|---|---|---|
| LNZ101 | Other | Drug: Aceclidine + BrimonidineAceclidine 1.75% / Brimonidine combination (non-preserved) ophthalmic solution |
| LNZ100 | Other | Drug: AceclidineAceclidine 1.75% (non-preserved) ophthalmic solution |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Each subject must:
Key exclusion criteria (6 listed)
- Each subject must not:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aceclidine + BrimonidineLNZ101 (Aceclidine/Brimonidine) non-preserved ophthalmic solution | Drug | LNZ101 |
| AceclidineLNZ100 (Aceclidine) non-preserved ophthalmic solution | Drug | LNZ100 |
Primary outcome
Cmax
Time frame: Day 1 and Day 8
Maximum plasma concentrations of LNZ100 and LNZ101
Tmax
Time frame: Day 1 and Day 8
Time of maximum plasma concentrations of LNZ100 and LNZ101
AUC0-t
Time frame: Day 1 and Day 8
Area under the concentration-time curve from time 0 to time t of LNZ100 and LNZ100
AUC0-inf
Time frame: Day 1 and Day 8
Area under the concentration-time curve from time 0 to infinity of LNZ100 and LNZ101
T1/2
Time frame: Day 1 and Day 8
Terminal half-life of LNZ100 and LNZ101
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
- Individual participant dataSharing planned: No. there is no plan.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kris Gameblin study director
LENZ Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Aceclidine + Brimonidine and Aceclidine in people with Eye Diseases and Presbyopia, run by LENZ Therapeutics, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: Day 1 and Day 8). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2023.