Healthy SubjectsPhase 1NCT06813807
A Comparative Study of the Pharmacokinetic Profiles of Timolol Maleate Ophthalmic Gel With Timolol Maleate Gel
A Phase 1 study testing 0.5% TM in people with Healthy Subjects, run by Auson Pharmaceuticals Inc. at 1 site in China.
Trial summary
The goal of this clinical trial is: 1)To evaluate the pharmacokinetic profiles and safety of 0.5% Timolol Maleate Ophthalmic Gel Forming Solution in healthy adult subjects after multiple dosing; 2)To compare the systemic exposure (Cmax,ss and AUCss) of 0.5% Timolol Maleate Gel in subjects with proliferating… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- 0.5% TM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2024to 5 Jul 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age and gender: Healthy male or female subjects aged 18 to 50 years old (inclusive);
- Weight: ≥ 50 kg for male, ≥ 45 kg for female; body mass index (BMI) between 19 and 26 kg/m2 (inclusive), where BMI = weight (kg) / height2 (m2);
- Ophthalmic examinations during screening include visual acuity, color vision, intraocular pressure, slit-lamp examination (of eyelids, lacrimal apparatus, anterior chamber, conjunctiva, etc.) and fundus examination must be normal or abnormal without clinical significance;
- Refractive myopia < 600 degrees, corrected visual acuity ≥ 0.8 in both eyes;
- Subjects with no abnormal or with abnormal but not clinically significant results in vital signs measurement, physical examination, clinical laboratory tests (hematology, urinalysis, blood biochemistry, infectious disease test and coagulation function), pregnancy test (women of childbearing age), and 12-lead ECG;
- Male subjects and their partners or female subjects must agree to take one or more non-drug contraceptive measures (such as complete abstinence, intrauterine ring and partner ligation) during the study and for 3 months after the end of the study, and have no plan of sperm or egg donation; Subjects have a full understanding of the study content, investigational drugs, study process, etc., and are able to communicate well with the investigator, willing to comply with the study regulations, and voluntarily sign the informed consent form.
Who cannot join
- (Screening period inquiry + check-in inquiry) Subjects with a history of respiratory system (especially bronchial asthma, bronchospasm, chronic obstructive pulmonary disease), cardiovascular system, digestive system, endocrine system, urinary system, nervous system, hematological, immunological, psychiatric disorders or a family history of genetic psychosis, cancer, etc., and are considered by the investigator to still have clinical significance;
- (Screening period inquiry) Subjects with a history of diabetes, thyrotoxicosis, cardiogenic shock, second- to third-degree atrioventricular block, heart failure, significant sinus bradycardia, hypotension, sick sinus syndrome, severe peripheral vascular disease with resting ischemia and whose condition is assessed by the study physician to be abnormal but clinically significant;
- (Screening period inquiry + check-in inquiry) Subjects who have undergone surgery within 6 months before the first dose that will affect drug absorption, distribution, metabolism and excretion as judged by the investigator; or who have undergone surgery within 4 weeks before the first dose; or who plan to undergo surgery during the study period;
- (Screening period inquiry) Subjects with a history of or currently suffering from any acute and chronic eye diseases, or with ocular mixed infections, inflammation, trauma or other ophthalmic conditions with clinical significance(e.g., keratoconus, severe dry eye) within 1 month before the first dose, active eye diseases, or acute or chronic allergic eye diseases or any abnormalities in the eyelids, ocular surface, and lacrimal passage system that may affect the absorption of eye drops in the opinion of the investigator;
- (Screening period inquiry) Subjects with a history of ocular trauma or eye surgery;
- Subjects whose elevated intraocular pressure exceeds the normal range (10 ~ 21 mmHg), with the pressure difference of greater than 5 mmHg between both eyes and considered clinically significant by the study doctor;
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- Subjects with keratopathy, corneal thickness greater than 600 um (normal central corneal thickness is 500 ~ 600 um) or corneal scarring, wearing contact lenses (including night wear orthokeratology lenses) or having to wear contact lenses during the study, which affect the intraocular pressure measurement and are considered clinically significant by the study physician;
- (Screening period inquiry) Those with evidence or a history of acute and chronic angle-closure glaucoma;
- (Screening period inquiry + check-in inquiry) Those who have used any drugs that inhibit or induce hepatic drug metabolizing enzymes or interact with the study drugs (adrenoceptor inhibitors, digitalis and calcium antagonists, catecholamine-depleting drugs, clonidine, quinidine, etc.) within 30 days prior to the first dose;
- (Screening period inquiry + check-in inquiry) Subjects who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, vaccines or health products for various reasons within 14 days prior to the first dose in the study;
- (Screening period inquiry) Subjects who are allergic to timolol maleate ophthalmic gel forming solution or its excipients; or those who are allergic to two or more items of other drugs, foods and environment; or those with allergic constitution who are prone to allergic symptoms such as rash (generalized rash, urticaria) and itching;
- (Screening period inquiry + check-in inquiry) Individuals with a history of drug abuse, drug dependence or positive results of drug abuse screening (morphine, methylamphetamine, ketamine, methylenedioxymethamphetamine, tetrahydrocannabinolic acid, cocaine);
- (Screening period inquiry + check-in inquiry) Those who are former smokers or have smoked more than 5 cigarettes per day on average within 3 months before screening, or are unable to stop using any tobacco products during the study;
- (Screening period inquiry + check-in inquiry) Subjects with a history of alcoholism/alcohol abuse or who are regular drinkers within 6 months prior to screening (ie, consuming more than 14 standard units of alcohol per week, where 1 standard unit equals to 17.5 mL or 14 g of pure alcohol. Alcohol content of different types of alcoholic beverages is indicated by volume ratio, 1 standard unit approximately equals to 35 mL of 50° liquor or 350 mL of 5° beer), or those who are unwilling to stop drinking or consuming any alcohol-containing products during the study, or with alcohol breath test results > 0.0 mg/100 mL;
- (Screening period inquiry + check-in inquiry) Subjects who have previously consumed excessive amounts of tea, coffee and/or caffeine-rich, grapefruit, xanthine-rich beverages (including tea, caffeine, cocoa) for a long period of time (more than 8 cups per day on average, 1 cup = 200 mL), or who have consumed any caffeine-rich, grapefruit-rich beverages or foods within 7 days before the first dose, or who do not agree to stop eating the above diet during the study;
- (Screening period inquiry) Subjects who have special requirements for diet and cannot follow the standardized diet of the site;
- (Screening period inquiry + check-in inquiry) Those who have donated or lost a large amount (≥ 400 mL) of blood within 3 months prior to enrollment or plan to donate blood or blood components within 3 months after the end of the study;
- (Screening period inquiry + online screening) Subjects who have participated in any clinical study and used the investigational drug within 90 days before screening;
- (Screening period inquiry) Subjects with a history of fainting due to needles or blood, difficulty in venous blood sampling and/or intolerance to venipuncture/indwelling needle;
- Subjects who have skin damage or scars or skin diseases at the application site (around the eyes) and cannot be enrolled at the investigator's discretion; Other factors that, in the opinion of the investigator, make the subject unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study of the Pharmacokinetic Profiles of Timolol Maleate Ophthalmic Gel Forming Solution After Multiple Dosing in Healthy Subjects With That of Timolol Maleate Gel in Subjects With Proliferating Superficial Infantile Hemangioma Who Have Completed the Study
The goal of this clinical trial is:
1)To evaluate the pharmacokinetic profiles and safety of 0.5% Timolol Maleate Ophthalmic Gel Forming Solution in healthy adult subjects after multiple dosing; 2)To compare the systemic exposure (Cmax,ss and AUCss) of 0.5% Timolol Maleate Gel in subjects with proliferating superficial infantile hemangioma (completed) with that of 0.5% Timolol Maleate Ophthalmic Gel Forming Solution in healthy adult subjects.
Read more
The main questions aim to answer are:
- Pharmacokinetic (PK) profiles of healthy adult subjects
- Safety Evaluation
- To compare the systemic exposure (Cmax,ss and AUCss) of 0.5% timolol maleate gel in subjects with proliferating superficial infantile hemangioma (completed) with that of 0.5% timolol maleate ophthalmic gel forming solution in healthy adult subjects.
- Conditions
- Healthy Subjects
- Being tested
- 0.5% TM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5% TMDrug
From D1 to D10, each subject will receive one drop of 0.5% timolol maleate ophthalmic gel forming solution each in the left and right eyes once daily at the same time every day under fasted condition.
| Study group | Role | What they receive |
|---|---|---|
| 0.5%TM | Experimental | 18 subjects will receive one drop of 0.5% timolol maleate ophthalmic gel forming solution each in the left and right eyes once daily. Receives: Drug: 0.5% TM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax,ss
maximum plasma concentration at steady state
Measured: 24 hours after administration
AUC0-t,ss
area under the plasma concentration-time curve from the last dose to the collection time t of the last measurable concentration
Measured: 24 hours after administration
AUC0-24,ss
area under the plasma concentration-time curve over a 24-h dosing interval at steady state
Measured: 24 hours after administration
AUC0-∞,ss
area under the plasma concentration-time curve extrapolated from the last dose to infinity at steady state
Measured: 24 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start15 Jun 2024
- Primary completion5 Jul 2024
- Study completion5 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Auson Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813807
- Sponsor's protocol ID
- ASN001C003-CN
- Status last verified
- Feb 2025
- First submitted
- 23 Jan 2025
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of the Pharmacokinetic Profiles of Timolol Maleate Ophthalmic Gel Forming Solution After Multiple Dosing in Healthy Subjects With That of Timolol Maleate Gel in Subjects With Proliferating Superficial Infantile Hemangioma Who Have Completed the Study
- ClinicalTrials.gov ID
- NCT06813807
- Acronym / sponsor ID
- ASN001C003-CN
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Auson Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 5 Jul 2024 (actual)
- Study completion
- 5 Jul 2024 (actual)
- First posted
- 7 Feb 2025 (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.
The goal of this clinical trial is:
1)To evaluate the pharmacokinetic profiles and safety of 0.5% Timolol Maleate Ophthalmic Gel Forming Solution in healthy adult subjects after multiple dosing; 2)To compare the systemic exposure (Cmax,ss and AUCss) of 0.5% Timolol Maleate Gel in subjects with proliferating superficial infantile hemangioma (completed) with that of 0.5% Timolol Maleate Ophthalmic Gel Forming Solution in healthy adult subjects.
The main questions aim to answer are:
- Pharmacokinetic (PK) profiles of healthy adult subjects
- Safety Evaluation
- To compare the systemic exposure (Cmax,ss and AUCss) of 0.5% timolol maleate gel in subjects with proliferating superficial infantile hemangioma (completed) with that of 0.5% timolol maleate ophthalmic gel forming solution in healthy adult subjects.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 0.5%TM | Experimental | Drug: 0.5% TM18 subjects will receive one drop of 0.5% timolol maleate ophthalmic gel forming solution each in the left and right eyes once daily. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age and gender: Healthy male or female subjects aged 18 to 50 years old (inclusive);
- Weight: ≥ 50 kg for male, ≥ 45 kg for female; body mass index (BMI) between 19 and 26 kg/m2 (inclusive), where BMI = weight (kg) / height2 (m2);
- Ophthalmic examinations during screening include visual acuity, color vision, intraocular pressure, slit-lamp examination (of eyelids, lacrimal apparatus, anterior chamber, conjunctiva, etc.) and fundus examination must be normal or abnormal without clinical significance;
- Refractive myopia < 600 degrees, corrected visual acuity ≥ 0.8 in both eyes;
- Subjects with no abnormal or with abnormal but not clinically significant results in vital signs measurement, physical examination, clinical laboratory tests (hematology, urinalysis, blood biochemistry, infectious disease test and coagulation function), pregnancy test (women of childbearing age), and 12-lead ECG;
Key exclusion criteria (20 listed)
- (Screening period inquiry + check-in inquiry) Subjects with a history of respiratory system (especially bronchial asthma, bronchospasm, chronic obstructive pulmonary disease), cardiovascular system, digestive system, endocrine system, urinary system, nervous system, hematological, immunological, psychiatric disorders or a family history of genetic psychosis, cancer, etc., and are considered by the investigator to still have clinical significance;
- (Screening period inquiry) Subjects with a history of diabetes, thyrotoxicosis, cardiogenic shock, second- to third-degree atrioventricular block, heart failure, significant sinus bradycardia, hypotension, sick sinus syndrome, severe peripheral vascular disease with resting ischemia and whose condition is assessed by the study physician to be abnormal but clinically significant;
- (Screening period inquiry + check-in inquiry) Subjects who have undergone surgery within 6 months before the first dose that will affect drug absorption, distribution, metabolism and excretion as judged by the investigator; or who have undergone surgery within 4 weeks before the first dose; or who plan to undergo surgery during the study period;
- (Screening period inquiry) Subjects with a history of or currently suffering from any acute and chronic eye diseases, or with ocular mixed infections, inflammation, trauma or other ophthalmic conditions with clinical significance(e.g., keratoconus, severe dry eye) within 1 month before the first dose, active eye diseases, or acute or chronic allergic eye diseases or any abnormalities in the eyelids, ocular surface, and lacrimal passage system that may affect the absorption of eye drops in the opinion of the investigator;
- (Screening period inquiry) Subjects with a history of ocular trauma or eye surgery;
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 |
|---|---|---|
| 0.5% TMFrom D1 to D10, each subject will receive one drop of 0.5% timolol maleate ophthalmic gel forming solution each in the left and right eyes once daily at the same time every day under fasted condition. | Drug | 0.5%TM |
Primary outcome
Cmax,ss
Time frame: 24 hours after administration
maximum plasma concentration at steady state
AUC0-t,ss
Time frame: 24 hours after administration
area under the plasma concentration-time curve from the last dose to the collection time t of the last measurable concentration
AUC0-24,ss
Time frame: 24 hours after administration
area under the plasma concentration-time curve over a 24-h dosing interval at steady state
AUC0-∞,ss
Time frame: 24 hours after administration
area under the plasma concentration-time curve extrapolated from the last dose to infinity at steady state
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 7 Feb 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 0.5% TM in people with Healthy Subjects, run by Auson Pharmaceuticals Inc. 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 6 inclusion and 20 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 7 Feb 2025. 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. 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,ss (time frame: 24 hours after administration). The study lists 4 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 7 Feb 2025.