A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety and … (NCT07098117) | Clinical Trial Compass
CompletedPhase 1
A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety and Pharmacokinetic Profile of Single and Multiple Dose Escalation Topical Dermal Administration of SHR0302 Alkali Gel in Healthy Subjects
China32 participantsStarted 2024-06-19
Plain-language summary
This study is divided into two parts, the first part is a single-dose dose escalation trial (SAD) in healthy subjects; The second part is a multiple-dose dose escalation trial (MAD) in healthy subjects.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Sign the informed consent form before the trial, fully understand the content, process and possible adverse reactions of the trial, and be able to complete the study according to the requirements of the trial protocol.
✓. Must be ≥ 18 years old and ≤ 55 years old on the day of signing the informed consent form, male or female;
✓. Male subjects weigh ≥ 50 kg, female subjects weigh ≥ 45 kg, and body mass index (BMI) within the range of 18.0\~28.0 kg/m2 (including boundary values);
✓. Subjects and their partners have no birth plan, do not donate sperm/eggs, and voluntarily take highly effective contraceptive measures (see Appendix 11 for specific contraceptive measures) from the study period to 6 months (female subjects) or 3 months (male subjects) after dosing, and the serum pregnancy test for female subjects must be negative and non-lactating.
Exclusion criteria
✕. Those who have had or are currently suffering from any clinically serious diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, blood system, immune system, psychiatric and metabolic abnormalities, or any other diseases that may interfere with the results of the trial in the judgment of the investigator;
✕. In the opinion of the investigator, the subject has skin lesions or abnormalities that may affect the evaluation of the study drug administration site, such as dermatitis, tattoos, scars, excessive hair, birthmarks, injuries, uneven skin tone, sunburn, etc.;
✕. Subjects have skin diseases that may affect the evaluation at the site of administration, such as vitiligo, eczema, acne, atopic dermatitis, dysplastic moles, or other skin lesions, or a history of skin cancer;
What they're measuring
1
Part 1, Skin local tolerability was assessed as moderate and above incidence, adverse events
Timeframe: 8days
2
Part 2, Skin local tolerability was assessed as moderate and above incidence, adverse events
. Those who have had serious infection, severe trauma or major surgical surgery within 6 months before screening; Those who plan to undergo surgery during the trial and within 2 weeks of the end;
✕. Positive hepatitis B virus surface antigen (HBsAg), human immunodeficiency virus antibody (HIV-Ab), Treponema pallidum antibody, and hepatitis C virus antibody (HCV-Ab) during the screening period;
✕. Estimated glomerular filtration rate (eGFR) calculated by the Dietary Modification for Nephrology (MDRD) formula (see Appendix 2) \< 90 mL/min/1.73 m² at screening, or serum creatinine exceeding the normal range, and judged by the investigator to be clinically significant and not suitable for participation in this investigator;
✕. Suspected allergy to the test drug or any ingredient in the test drug;
✕. Abnormal vital signs, physical examination, laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function), chest stereotype, abdominal ultrasound and 12-lead electrocardiogram at screening and judged by the investigator to be unsuitable for participation in this study;