A Phase I clinical trial to evaluate the safety and pharmacokinetics of SHR0302 base ointment at single dose and multiple dose in healthy adult subjects
- Conditions
- Atopic dermatitisSkin - Dermatological conditions
- Registration Number
- ACTRN12619001443189
- Lead Sponsor
- Reistone Biopharma Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 32
1.Healthy adult subjects between 18-55 years of age (inclusive), male or female, at the time of informed consent.
2.The body mass index (BMI equal to body mass/square of body height) of the subjects ranges from 19 to 26 kg/m2 (inclusive), and males of weight less than or equal to 50 kg, females of weight less than or equal to 45 kg.
3.The overall health is good at screening, as determined by medical history, physical examination, vital signs, laboratory examination, 12-lead electrocardiogram (ECG) and chest X-ray at screening.
4.All women of childbearing potential who are not in same-sex relationships and all men with female partner of childbearing potential must be willing to use effective method of contraception from signing of informed consent form, throughout the duration of the study, and for 1 month after last dose of study medication. The subjects understand and comply with the study requirements, voluntarily participate in the study and sign the informed consent form.
Subjects presenting with any of the following items will not be enrolled in this study:
1.Currently having or have a history of any of the following diseases:
1)Suspected allergy to the study drug or any component of the study drug, or allergy constitution;
2)Have a history of malignant tumor;
3)Skin injuries or abnormalities that might affect the evaluation of study drug application site, such as dermatitis, tattoo, scar, excessive hair, birthmark, injury, uneven skin color, sunburn, etc.;
4)In the opinion of the investigator, any clinically relevant skin diseases that are contraindicated in the study or affect the evaluation of application site, including psoriasis, eczema, acne, atopic dermatitis, dysplastic nevus, or other skin lesions, or a history of skin cancer;
5)Subjects with a history of herpes simplex or herpes zoster;
6)Subjects who currently have thyroid disorders (including hyperthyroidism, hypothyroidism, or are currently receiving thyroid replacement therapy. Subjects with abnormal TSH, fT4, and fT3 values on blood tests at screening must be excluded;
7)Subjects who have received any surgical operation within 3 months prior to screening or plan to receive the operation during the study and within 1 month after completing all study visits;
8)Subjects with a history of clinical major heart disease, liver disease, nerve disease, respiratory disease, blood disease, digestive disease, immune disease, kidney disease or mental disease, which is considered by the investigator to confuse the study results or affect absorption, distribution, metabolism and excretion of drug or place the subjects at improper risks;
9)Clinical symptoms, signs, laboratory examination or chest X-ray indicate active tuberculosis;
10)Subjects who have the investigator-judged clinically significant infections within 1 months prior to screening, including acute and chronic infections such as abscess, furuncle, carbuncle, respiratory tract infection, urinary and reproductive infection, and systematic infections, etc.
2.Subjects who are using or have a history of using any of the following drugs:
1)Subjects who are unable to discontinue CYP3A inducer or CYP3A inhibitor 2 weeks prior to the baseline visit and during the study;
2)Subjects who have inoculated any live vaccine within 1 month before screening or need to inoculate live vaccine during the study (including 30 days after the last dose of study drug);
3)Prescription drugs are used within 14 days before baseline;
4)OTC drugs are used within 14 days before baseline, including natural health products (e.g. food supplement and herbal supplement), with the exception of occasional use of paracetamol (up to 2 g per day);
5)Topical skin products (including sun-screening agents, moisturizers, cosmetics, insect repellents, creams, powders, lotions, sprays or gels) are used within 48 hours before baseline;
6)Topical skin drugs (e.g., topical hormones, vitamin A) are used at the study application site within 21 days before baseline
3.Any of the following laboratory endpoints meet the following criteria at screening or baseline examination:
1)The ECG shows QTc greater than 450 ms or any other obvious abnormality, which is determined as clinically significant by the investigator;
2)Blood routine examination shows that the white blood count, neutrophil count, lymphocyte count, or hemoglobin exceed the normal reference range and is clinically significant as determined by t
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the safety and tolerability of 1% and 2% SHR0302 base ointment in a single topical dose in healthy adult subjects.[Vital signs: collect systolic pressure and diastolic pressure (sitting), body temperature, heart rate, respiration after at least 5 min of rest. The timing of vital signs measurement on Day 1 will be 0.5h pre-dose, and 2, 4, 12 and 24 h after administration.<br><br>Physical Exam: collected at screening, Day -1, and Day 3 post IP administration.<br><br>Adverse Events: collected from the start of dosing to completion of final follow up. AEs will be assessed at Day -1, Day 1 during dosing and at all FU (Day 5 and Day 8 post dose) visits after dosing. There are no known AEs expected but skin will be assessed for any irritation throughout each visit.]
- Secondary Outcome Measures
Name Time Method To evaluate the pharmacokinetics of 1% and 2% SHR0302 base ointment in a single or multiple topical dose in healthy adult subjects. The plasma drug concentration and PK parameters of SHR0302 after single topical dose, including but not limited to: AUC(0-t), AUC(0-24), Cmax, Tmax, CL/F, Vz/F and half-life (t1/2). No exploratory PK analysis will be undertaken. [Plasma samples for PK analysis are collected within 1 h before dosing on D1, at 0.5, 1, 2, 4, 6, 8, 12h (±10 min for all) and 24, 36, 48, 96 and 168h (±30 min for all) after dosing for Part 1. ]