Healthy SubjectsPhase 1NCT06824948

Evaluate the Safety, Tolerance, and Pharmacokinetic Profiles of Timolol Maleate Gel

A Phase 1 study testing Timolol Maleate Gel in people with Healthy Subjects, run by Auson Pharmaceuticals Inc. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goal of this clinical trial is to to evaluate the safety, tolerance, and pharmacokinetic profiles of Timolol Maleate Gel in healthy Chinese adult subjects. The main questions aim to answer are: The pharmacokinetic endpoints: Single dose:Tmax, Cmax, etc. Multiple doses:AUC0-t, AUC0-inf, λz, t1/2, etc. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Subjects
What is being tested?: Timolol Maleate Gel
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 28 participants
Where: 1 siteChina
Study dates: 12 Oct 2018to 12 Dec 2018
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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy adult male or female subjects aged 18-55 years (including the cut point, subject to the time of signing the ICF);
Subjects with the body mass index (BMI) of 19-26 kg/m2 (including the cut point), where the body weight should be ≥ 50 kg for male subjects and ≥ 45 kg for female subjects;
Subjects who have no pregnancy plan, voluntarily adopt effective birth controls, and have no sperm donation or egg donation plan during the study until 3 months after the last dose. For specific birth controls, see Appendix 1: Birth Control, Definition of Female Subjects of Childbearing Age, and Contraception Requirements;
Subjects fully understand the study objective, nature, methods and possible adverse reactions, voluntarily become subjects, and sign the ICFs;
Subjects who have no skin damage or scar or skin disease at the administration site; Subjects who can complete the trial as required in the protocol.

Who cannot join

Subjects who are allergic to timolol maleate and similar drugs;
Subjects who have any difficulty in venous blood collection;
Subjects who have cardiogenic shock, Grade I or Grade III atrioventricular block, cardiac failure, sinus bradycardia, hypotension, and CS as assessed by the study physician;
Subjects who have bronchial asthma, airway sensitive disease, ventilation difficult or other pulmonary disorders;
Subjects who have had a history of drug abuse in the past five years or used drugs within the 3 months before the study; or subjects who are positive in the drug abuse screening test in the screening phase;
Subjects who have smoked more than 5 cigarettes a day within the 3 months before screening;

Show all 18Show fewer

Subjects who have consumed more than 14 units of alcohol (1 unit of alcohol = 360 mL beer or 45 mL 40% spirits or 150 mL wine) weekly within 6 months before the screening or have taken alcohol-containing products 48 h pre-dose, or were or positive in the alcohol breath test in the screening phase and/or the baseline phase;
Subjects who have used any drug that induces or inhibits liver metabolic enzymes within 28 days pre-dose in the study;
Subjects who have used any Rx, OTC or Chinese herbal medicine within 14 days pre-dose in the study;
Subjects who have took food or drink (such as grapefruit) containing enzymes that can induce or inhibit liver metabolism within 7 days pre-dose in the study;
Subjects who have ingested any food or drink containing caffeine or xanthine (e.g., coffee, tea, chocolate) during the period at 48 ho pre-dose to completion of the last PK blood sampling;
Subjects who have diseases or factors with clinical abnormalities, including but not limited to neurological, cardiovascular, blood, liver, kidney, gastrointestinal, respiratory, metabolic, endocrine, immune, skeletal system diseases or other factors;
Results of the vital signs assessment, physical examinations, laboratory test, 12-lead electrocardiogram and chest radiograph showed CS;
Subjects who are human immunodeficiency virus (HIV) antibody positive, hepatitis B surface antigen positive, hepatitis C virus antibody positive, or syphilis antibody positive;
Female subjects who are positive for pregnancy test in the screening phase or the baseline phase or who are breastfeeding;
Subjects who have had a clinically significant major disease or major surgical procedure within 4 weeks prior to dosing, or was expected to require major surgery during the study;
Subjects who have participated in other clinical drug trials within 3 months pre-dose in the study;
Subjects who have donated blood or blood loss > 400 mL within 3 months before screening; Any other circumstances that may affect the subjects in providing ICFs or following the study protocol, or participation in the study may affect the study results or the subjects' own safety as assessed by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai Xuhui District Central Hospital
Shanghai, Shanghai Municipality, 200031

Other trials in China

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Multiple-Dose Phase I Clinical Study to Evaluate the Safety, Tolerance, and Pharmacokinetic Profiles of Timolol Maleate Gel in Healthy Chinese Adult Subjects

The goal of this clinical trial is to to evaluate the safety, tolerance, and pharmacokinetic profiles of Timolol Maleate Gel in healthy Chinese adult subjects. The main questions aim to answer are:

The pharmacokinetic endpoints: Single dose:Tmax, Cmax, etc. Multiple doses:AUC0-t, AUC0-inf, λz, t1/2, etc.
The safety and tolerance endpoints: Physical examination, vital signs, 12-lead ECG, laboratory tests (hematology, blood biochemistry and urinalysis), adverse events, local tolerance.

Researchers will compare TM gel to a placebo (a look-alike substance that contains no drug) to see if TM gel works to treat IH.

Conditions: Healthy Subjects
Being tested: Timolol Maleate Gel, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timolol Maleate GelDrug
A 2-day washout phase follows 1 dose on Day 1, the subjects are applied with 0.5% timolol maleate gel one time a day during Day 3-Day 12.
PlaceboDrug
A 2-day washout phase follows 1 dose on Day 1, the subjects are applied with placebo one time a day during Day 3-Day 12.
Timolol Maleate GelDrug
A 2-day washout phase follows 1 dose on Day 1, the subjects are applied with 0.5% timolol maleate gel 2 times a day during Day 3-Day 12.
PlaceboDrug
A 2-day washout phase follows 1 dose on Day 1, the subjects are applied with placebo 2 times a day during Day 3-Day 12.
Timolol Maleate GelDrug
A 2-day washout phase follows 1 dose on Day 1, the subjects are applied with 0.5% timolol maleate gel 3 times a day during Day 3-Day 12.
PlaceboDrug
A 2-day washout phase follows 1 dose on Day 1, the subjects are applied with placebo 3 times a day during Day 3-Day 12.

Study groups in NCT06824948
Study group	Role	What they receive
Group 2-0.5%TM	Experimental	Participants will be randomized to receive 0.5%TM or matching placebo 2 times a day. Receives: Drug: Timolol Maleate Gel; Drug: Placebo
Group 3-0.5%TM	Experimental	Participants will be randomized to receive 0.5%TM or matching placebo 3 times a day. Receives: Drug: Timolol Maleate Gel; Drug: Placebo
Group 1-0.5%TM	Experimental	Participants will be randomized to receive 0.5%TM or matching placebo 1 time a day. Receives: Drug: Timolol Maleate Gel; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Local tolerance
Local tolerance will be evaluated by an investigator or designated evaluator (e.g., dermatologist) using the blinding method.The intensity (e.g., No evidence of irritation;Minimal erythema that is barely perceptible;Definite erythema that is readily visible and minimal edema or minimal papular response;Erythema and papules, et al) of the skin response is assessed on a 8 point scale.Other response score is assessed from "A" to "H".
Measured: 13 Days
Adverse events
Frequency, severity and relatedness of adverse events
Measured: Throughout study completion, an average 13 days
Vital signs (blood pressure)
Number of participants with clinically significant changes in vital signs (blood pressure)
Measured: the screening phase, Day -1, Day 1, 3, 6, 9, 12, and Day 13.
Vital signs (temperature)
Number of participants with clinically significant changes in vital signs (temperature)
Measured: the screening phase, Day -1, Day 1, 3, 6, 9, 12, and Day 13.
Vital signs (pulse rate)
Number of participants with clinically significant changes in vital signs (pulse rate)
Measured: the screening phase, Day -1, Day 1, 3, 6, 9, 12, and Day 13.
Laboratory tests
Number of participants with clinical laboratory abnormalities (including hematology, blood biochemistry and urinalysis).
Measured: the screening phase, the baseline phase, and on Days 6 and 13.
Physical examinations
Number of participants with clinically significant changes in physical examinations.
Measured: the screening phase, baseline phase and on Day 13
12-lead ECG
Number of participants with clinically significant changes in 12-lead ECG.
Measured: the screening phase, baseline phase, Day 1, 3, 6, 9, 12, and Day 13.

Secondary outcomes (7)

Tmax
The pharmacokinetics of single and multiple dose levels in participants will include peak time.
Measured: Day1 to Day13
Cmax
The pharmacokinetics of single and multiple dose levels in participants will include peak concentration.
Measured: Day1 to Day13
AUC0-t
The pharmacokinetics of single and multiple dose levels in participants will include area under drug concentration-time curve.
Measured: Day1 to Day13
AUC0-inf
area under drug concentration-time curve (AUC0-t) from 0 to t for the last accurately measurable concentration, area under drug concentration-time curve from 0 to infinity
Measured: Day1 to Day13
λz
The pharmacokinetics of single and multiple dose levels in participants will include elimination rate constant.
Measured: Day1 to Day13
t1/2
The pharmacokinetics of single and multiple dose levels in participants will include elimination half-life.
Measured: Day1 to Day13
%AUCex
The pharmacokinetics of single and multiple dose levels in participants will include AUC extrapolation percentage.
Measured: Day1 to Day13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Oct 201812 Dec 2018

First posted13 Feb 2025
Study start12 Oct 2018
Primary completion12 Dec 2018
Study completion12 Dec 2018

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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06824948
Sponsor's protocol ID: ASN001C001
Other IDs: CRC-C1824
Status last verified: Feb 2025
First submitted: 23 Jan 2025
Last updated: 13 Feb 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Multiple-Dose Phase I Clinical Study to Evaluate the Safety, Tolerance, and Pharmacokinetic Profiles of Timolol Maleate Gel in Healthy Chinese Adult Subjects
ClinicalTrials.gov ID: NCT06824948
Acronym / sponsor ID: ASN001C001
Conditions: Healthy Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Auson Pharmaceuticals Inc.Industry (pharma, biotech, devices)
Study start: 12 Oct 2018 (actual)
Primary completion: 12 Dec 2018 (actual)
Study completion: 12 Dec 2018 (actual)
First posted: 13 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 to to evaluate the safety, tolerance, and pharmacokinetic profiles of Timolol Maleate Gel in healthy Chinese adult subjects. The main questions aim to answer are:

The pharmacokinetic endpoints: Single dose:Tmax, Cmax, etc. Multiple doses:AUC0-t, AUC0-inf, λz, t1/2, etc.
The safety and tolerance endpoints: Physical examination, vital signs, 12-lead ECG, laboratory tests (hematology, blood biochemistry and urinalysis), adverse events, local tolerance.

Researchers will compare TM gel to a placebo (a look-alike substance that contains no drug) to see if TM gel works to treat IH.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Group 2-0.5%TM	Experimental	Drug: Timolol Maleate Gel, Drug: PlaceboParticipants will be randomized to receive 0.5%TM or matching placebo 2 times a day.
Group 3-0.5%TM	Experimental	Drug: Timolol Maleate Gel, Drug: PlaceboParticipants will be randomized to receive 0.5%TM or matching placebo 3 times a day.
Group 1-0.5%TM	Experimental	Drug: Timolol Maleate Gel, Drug: PlaceboParticipants will be randomized to receive 0.5%TM or matching placebo 1 time a day.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Healthy adult male or female subjects aged 18-55 years (including the cut point, subject to the time of signing the ICF);
Subjects with the body mass index (BMI) of 19-26 kg/m2 (including the cut point), where the body weight should be ≥ 50 kg for male subjects and ≥ 45 kg for female subjects;
Subjects who have no pregnancy plan, voluntarily adopt effective birth controls, and have no sperm donation or egg donation plan during the study until 3 months after the last dose. For specific birth controls, see Appendix 1: Birth Control, Definition of Female Subjects of Childbearing Age, and Contraception Requirements;
Subjects fully understand the study objective, nature, methods and possible adverse reactions, voluntarily become subjects, and sign the ICFs;
Subjects who have no skin damage or scar or skin disease at the administration site; Subjects who can complete the trial as required in the protocol.

Key exclusion criteria (18 listed)

Subjects who are allergic to timolol maleate and similar drugs;
Subjects who have any difficulty in venous blood collection;
Subjects who have cardiogenic shock, Grade I or Grade III atrioventricular block, cardiac failure, sinus bradycardia, hypotension, and CS as assessed by the study physician;
Subjects who have bronchial asthma, airway sensitive disease, ventilation difficult or other pulmonary disorders;
Subjects who have had a history of drug abuse in the past five years or used drugs within the 3 months before the study; or subjects who are positive in the drug abuse screening test in the screening phase;

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
Timolol Maleate GelA 2-day washout phase follows 1 dose on Day 1, the subjects are applied with 0.5% timolol maleate gel one time a day during Day 3-Day 12.	Drug	Group 1-0.5%TM
PlaceboA 2-day washout phase follows 1 dose on Day 1, the subjects are applied with placebo one time a day during Day 3-Day 12.	Drug	Group 1-0.5%TM
Timolol Maleate GelA 2-day washout phase follows 1 dose on Day 1, the subjects are applied with 0.5% timolol maleate gel 2 times a day during Day 3-Day 12.	Drug	Group 2-0.5%TM
PlaceboA 2-day washout phase follows 1 dose on Day 1, the subjects are applied with placebo 2 times a day during Day 3-Day 12.	Drug	Group 2-0.5%TM
Timolol Maleate GelA 2-day washout phase follows 1 dose on Day 1, the subjects are applied with 0.5% timolol maleate gel 3 times a day during Day 3-Day 12.	Drug	Group 3-0.5%TM
PlaceboA 2-day washout phase follows 1 dose on Day 1, the subjects are applied with placebo 3 times a day during Day 3-Day 12.	Drug	Group 3-0.5%TM

Primary outcome

Local tolerance
Time frame: 13 Days
Local tolerance will be evaluated by an investigator or designated evaluator (e.g., dermatologist) using the blinding method.The intensity (e.g., No evidence of irritation;Minimal erythema that is barely perceptible;Definite erythema that is readily visible and minimal edema or minimal papular response;Erythema and papules, et al) of the skin response is assessed on a 8 point scale.Other response score is assessed from "A" to "H".
Adverse events
Time frame: Throughout study completion, an average 13 days
Frequency, severity and relatedness of adverse events
Vital signs (blood pressure)
Time frame: the screening phase, Day -1, Day 1, 3, 6, 9, 12, and Day 13.
Number of participants with clinically significant changes in vital signs (blood pressure)
Vital signs (temperature)
Time frame: the screening phase, Day -1, Day 1, 3, 6, 9, 12, and Day 13.
Number of participants with clinically significant changes in vital signs (temperature)
Vital signs (pulse rate)
Time frame: the screening phase, Day -1, Day 1, 3, 6, 9, 12, and Day 13.
Number of participants with clinically significant changes in vital signs (pulse rate)
Laboratory tests
Time frame: the screening phase, the baseline phase, and on Days 6 and 13.
Number of participants with clinical laboratory abnormalities (including hematology, blood biochemistry and urinalysis).
Physical examinations
Time frame: the screening phase, baseline phase and on Day 13
Number of participants with clinically significant changes in physical examinations.
12-lead ECG
Time frame: the screening phase, baseline phase, Day 1, 3, 6, 9, 12, and Day 13.
Number of participants with clinically significant changes in 12-lead ECG.

7 secondary outcomes

Tmax
Time frame: Day1 to Day13
Cmax
Time frame: Day1 to Day13
AUC0-t
Time frame: Day1 to Day13
AUC0-inf
Time frame: Day1 to Day13
λz
Time frame: Day1 to Day13
t1/2
Time frame: Day1 to Day13
%AUCex
Time frame: Day1 to Day13

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 13 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 Timolol Maleate Gel 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 5 inclusion and 18 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 13 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?

Local tolerance (time frame: 13 Days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06824948.

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 13 Feb 2025.