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A Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of Timolol Maleate Cream Administered in Healthy Subjects

A Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of Timolol Maleate Cream Administered in Healthy Subjects

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064570
Enrollment
Unknown
Registered
2022-10-12
Start date
2022-10-10
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infantile hemangioma

Interventions

Group 1 :0.5% Timolol Maleate Cream

Sponsors

Shanghai Xuhui Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Male or female healthy subjects aged 18-55 years; 2. Weight: male >= 50 kg, female >= 45 kg; 19 kg/m2 <= body mass index (BMI) <= 28 kg/m2; 3. Subjects who have no pregnancy plan and voluntarily take effective contraceptive measures during the test period to 3 months after the last administration, and have no plan to donate sperm or eggs; 4. The subject fully understands the purpose, nature, method and possible adverse reactions of the test, volunteers as a subject, and signs an informed consent; 5. Those who have no skin damage or scars or skin diseases at the medication site.

Exclusion criteria

Exclusion criteria: 1. Those who are known to be allergic to timolol maleate, or to other ß-blockers or have a history of severe allergies, or allergic constitution; 2. Suffering from malignant tumors and diseases of the heart, endocrine, blood, liver, immunity, metabolism, urinary system, lungs, nervous system, rheumatism/joints, spirit, kidney, etc., which the researchers consider unsuitable for participation Participants in this clinical trial; 3. Severe heart disease or asthma, severe respiratory disease; 4. Have a history of atopic dermatitis; 5. Received vaccination within 1 month (30 days) before screening; 6. Those who have used clinical trial drugs within 3 months (90 days) before screening, are participating in or plan to participate in other clinical trials during this study; 7. Those who have used any prescription drugs, non-prescription drugs or Chinese herbal medicines within 14 days before screening; 8. Those who have a history of drug abuse or who are positive for drug abuse screening; 9. Hepatitis B surface antigen, hepatitis C virus antibody, Treponema pallidum antibody positive, HIV test positive; 10. Physical examination, vital signs, laboratory tests (blood routine, urine routine, blood biochemistry), 12-lead electrocardiogram results and chest X-ray examination judged by clinicians to be abnormal and have clinical significance; 11. The subject may not be able to complete the study due to other reasons or the researcher believes that it should not be included.

Design outcomes

Primary

MeasureTime frame
Cmax for Timolol;

Countries

China

Contacts

Public ContactJingying Jia

Shanghai Xuhui Central Hospital

jyjia@shxh-centerlab.com+86 21 54030254

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026