PresbyopiaPhase 1NCT06270030
Safety, Tolerability and Pharmacokinetics of LNZ101 and LNZ100 Ophthalmic Solutions in Healthy Adult Chinese With Presbyopia
A Phase 1 study testing LNZ101 (Aceclidine /Brimonidine) ophthalmic solution and LNZ100 (Aceclidine) ophthalmic solution in people with Presbyopia, run by Corxel Pharmaceuticals at 1 site in China.
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 Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Presbyopia
- What is being tested?
- LNZ101 (Aceclidine /Brimonidine) ophthalmic solution and LNZ100 (Aceclidine) ophthalmic solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 4 Mar 2024to 10 Apr 2024
- 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
- Be able and willing to provide written informed consent prior to any study procedure being performed.
- 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.
- Be Chinese healthy male or female subjects aged 45-75 years (inclusive) at screening.
- Be diagnosed and documented to have presbyopia by the investigator at the screening visit.
Who cannot join
- 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.
- 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.
- 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.
- Have prior (within 14 days of the first dose), current or anticipated use of any contact lenses during study participation.
- Be ineligible for this trial in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
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
Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LNZ101 and LNZ100 Ophthalmic Solutions in Chinese Healthy Adult Subjects with Presbyopia
Read the 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
- Conditions
- Presbyopia
- Being tested
- LNZ101 (Aceclidine /Brimonidine) ophthalmic solution, LNZ100 (Aceclidine) ophthalmic solution, Placebo (Vehicle) ophthalmic solution
- Keywords
- Presbyopia, LNZ100, LNZ101
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LNZ101 (Aceclidine /Brimonidine) ophthalmic solutionDrug
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 solutionDrug
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 solutionDrug
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
| Study group | Role | What they receive |
|---|---|---|
| LNZ101 (Aceclidine /Brimonidine) ophthalmic solution | Experimental | Drug: Aceclidine/Brimonidine ophthalmic solution Other Names: LNZ101 Receives: Drug: LNZ101 (Aceclidine /Brimonidine) ophthalmic solution |
| LNZ100 (Aceclidine) ophthalmic solution | Experimental | Drug: Aceclidine ophthalmic solution Other Names: LNZ100 Receives: Drug: LNZ100 (Aceclidine) ophthalmic solution |
| Placebo (Vehicle) ophthalmic solution | Placebo comparator | Drug: Placebo (Vehicle) ophthalmic solution Other Names: NA Receives: Drug: Placebo (Vehicle) ophthalmic solution |
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-∞
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
Safety: adverse event reporting
The number of patients who experience one or more AE during the treatment period
Measured: up to 23 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start4 Mar 2024
- Primary completion10 Apr 2024
- Study completion10 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PresbyopiaStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corxel Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- LENZ Therapeutics, Inc
- Responsible party
- Sponsor
- Investigators
- Larry Li, Doctor, Study director, Corxel Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270030
- Sponsor's protocol ID
- JX07002
- Other IDs
- CTR20240460
- Status last verified
- Apr 2024
- First submitted
- 6 Feb 2024
- Last updated
- 23 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06270030
- Acronym / sponsor ID
- JX07002
- Conditions
- Presbyopia
- Keywords
- Presbyopia, LNZ100, LNZ101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Corxel PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- LENZ Therapeutics, Inc
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 10 Apr 2024 (actual)
- Study completion
- 10 Apr 2024 (actual)
- First posted
- 21 Feb 2024 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LNZ101 (Aceclidine /Brimonidine) ophthalmic solution | Experimental | Drug: LNZ101 (Aceclidine /Brimonidine) ophthalmic solutionDrug: Aceclidine/Brimonidine ophthalmic solution Other Names: LNZ101 |
| LNZ100 (Aceclidine) ophthalmic solution | Experimental | Drug: LNZ100 (Aceclidine) ophthalmic solutionDrug: Aceclidine ophthalmic solution Other Names: LNZ100 |
| Placebo (Vehicle) ophthalmic solution | Placebo comparator | Drug: Placebo (Vehicle) ophthalmic solutionDrug: Placebo (Vehicle) ophthalmic solution Other Names: NA |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be able and willing to provide written informed consent prior to any study procedure being performed.
- 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.
- Be Chinese healthy male or female subjects aged 45-75 years (inclusive) at screening.
- Be diagnosed and documented to have presbyopia by the investigator at the screening visit.
Key exclusion criteria (5 listed)
- 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.
- 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.
- 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.
- Have prior (within 14 days of the first dose), current or anticipated use of any contact lenses during study participation.
- Be ineligible for this trial in the opinion of the investigator.
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 |
|---|---|---|
| LNZ101 (Aceclidine /Brimonidine) ophthalmic solutionOnce 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 | Drug | LNZ101 (Aceclidine /Brimonidine) ophthalmic solution |
| LNZ100 (Aceclidine) ophthalmic solutionOnce 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 | Drug | LNZ100 (Aceclidine) ophthalmic solution |
| Placebo (Vehicle) ophthalmic solutionOnce 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 | Drug | Placebo (Vehicle) ophthalmic solution |
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-∞
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
Safety: adverse event reporting
Time frame: up to 23 days
The number of patients who experience one or more AE during the treatment period
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 23 Apr 2024.
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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.
Larry Li, Doctor study director
Corxel Pharmaceuticals
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 LNZ101 (Aceclidine /Brimonidine) ophthalmic solution and LNZ100 (Aceclidine) ophthalmic solution in people with Presbyopia, run by Corxel Pharmaceuticals at 1 site in China.
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 4 inclusion and 5 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 23 Apr 2024. 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 China. 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. Some participants in this study may receive a placebo. 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 6 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 23 Apr 2024.