Evaluate the Safety, Tolerance, and Pharmacokinetic Profiles of Timolol Maleate Gel (NCT06824948) | Clinical Trial Compass
CompletedPhase 1
Evaluate the Safety, Tolerance, and Pharmacokinetic Profiles of Timolol Maleate Gel
China28 participantsStarted 2018-10-12
Plain-language 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.
• 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.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Local tolerance
Timeframe: 13 Days
2
Adverse events
Timeframe: Throughout study completion, an average 13 days
3
Vital signs (blood pressure)
Timeframe: the screening phase, Day -1, Day 1, 3, 6, 9, 12, and Day 13.
4
Vital signs (temperature)
Timeframe: the screening phase, Day -1, Day 1, 3, 6, 9, 12, and Day 13.
5
Vital signs (pulse rate)
Timeframe: the screening phase, Day -1, Day 1, 3, 6, 9, 12, and Day 13.
6
Laboratory tests
Timeframe: the screening phase, the baseline phase, and on Days 6 and 13.
7
Physical examinations
Timeframe: the screening phase, baseline phase and on Day 13
. 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;
. 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;
12-lead ECG
Timeframe: the screening phase, baseline phase, Day 1, 3, 6, 9, 12, and Day 13.