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

Reistone Biopharma Co., Ltd.0 sites32 target enrollmentOctober 17, 2019

ConditionsAtopic dermatitis Skin - Dermatological conditions

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Atopic dermatitis
Sponsor: Reistone Biopharma Co., Ltd.
Enrollment: 32
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 17, 2019

End Date

December 17, 2019

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Reistone Biopharma Co., Ltd.

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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;