This is a Phase I, Randomized, Double-blind, Vehicle-controlled Study of QY101 Ointment in Chinese Healthy Subjects
概览
- 阶段
- 1 期
- 干预措施
- QY101 ointment or vehicle
- 疾病 / 适应症
- Healthy Volunteer
- 发起方
- E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd.
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Number of Participants With Clinical Laboratory Abnormalities
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
This is a phase I, randomized, double-blind, vehicle-controlled，single and multiple ascending dose study to assess the safety, tolerability, and pharmacokinetics of QY101 ointment in Chinese healthy subjects
研究者
入排标准
入选标准
- •The subjects were fully aware of the purpose, nature, methods and possible adverse reactions of the trial, volunteered as subjects, and signed an informed consent form before the start of any research process.
- •Male and female subjects aged 18 to 45 (including 18 and 45).
- •Male weight≥50.0 kg, female weight≥45.0 kg; BMI is in the range of 19.0 \~ 26.0 kg/ m2 (including the critical value).
- •The subjects had no history of chronic or serious diseases such as cardiovascular, liver, kidney, respiration, blood and lymph, endocrine, immune, mental, nervous, gastrointestinal system, and were in good health.
- •Physical examination, vital signs, clinical laboratory examination values (blood routine, urine routine, blood biochemistry, blood coagulation function, stool routine and occult blood, pregnancy test (female), hepatitis, HIV, syphilis), 12-lead ECG, chest X-ray examination, abdominal ultrasound examination results are all within the normal range or abnormalities with no clinical significance.
- •The subjects (including male subjects) had no fertility plan, voluntary use of effective contraception and no plan to donate sperm or eggs during the screening period and within 6 months after the end of the last administration.
- •The subjects were able to communicate well with the researchers and understand and comply with the requirements of this study.
排除标准
- •Allergic constitution, such as a history of allergy to two or more drugs and food, or those known to be allergic to QY101 and excipients.
- •Screen those who have undergone surgery within the previous 3 months, or who plan to undergo surgery during the study period, or who have undergone surgery that will affect the absorption, distribution, metabolism and excretion of drugs.
- •Diseases that need to be excluded with abnormal clinical manifestations, including, but not limited to, diseases of the nervous system, cardiovascular system, blood and lymphoid system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolic and skeletal system, etc.
- •Subjects who cannot tolerate venipuncture, have a history of dizzy needles and blood sickness.
- •Subjects with a history of severe skin disease (subject to the judgment of the researcher).
- •Live (attenuated) vaccine was vaccinated within 2 months before screening.
- •Smoking or drinking within 3 months before screening (smoking: \> 10 cigarettes per day; drinking: \> 15g pure alcohol per day, equivalent to 450mL beer, 150mL wine or 50mL low alcohol), or positive for nicotine, alcohol, abuse drugs (morphine / methamphetamine / ketamine / dimethylene dioxyamphetamine / tetrahydrocannabinic acid).
- •Screen subjects who have participated in other drug clinical trials or have not come to participate in clinical trials within the first 3 months.
- •Non-physiological blood loss ≥ 200ml within 3 months before screening (including trauma, blood collection, blood donation), or plan to donate blood during the study period or within 1 month after the end of the study.
- •The subjects (female) are lactating.
研究组 & 干预措施
SAD Cohort 1(0.1% QY101 ointment or vehicle apply to 5%BSA)
3 subjects use 0.1% QY101 ointment，1 subject uses vehicle topical applied to 5% Body Surface Area，assessed until 72 hours postdose
干预措施: QY101 ointment or vehicle
SAD Cohort 2(0.1% QY101 ointment or vehicle apply to 20%BSA)
6 subjects use 0.1% QY101 ointment，2 subjects use vehicle topical applied to 20% Body Surface Area，assessed until 72 hours postdose
干预措施: QY101 ointment or vehicle
SAD Cohort 3(0.3% QY101 ointment or vehicle apply to 20%BSA)
6 subjects use 0.3% QY101 ointment，2 subjects use vehicle topical applied to 20% Body Surface Area，assessed until 72 hours postdose
干预措施: QY101 ointment or vehicle
SAD Cohort 4(0.5% QY101 ointment or vehicle apply to 20%BSA)
6 subjects use 0.5% QY101 ointment，2 subjects use vehicle topical applied to 20% Body Surface Area，assessed until 72 hours postdose
干预措施: QY101 ointment or vehicle
SAD Cohort 5(1.0% QY101 ointment or vehicle apply to 20%BSA)
6 subjects use 1.0% QY101 ointment，2 subjects use vehicle topical applied to 20% Body Surface Area，assessed until 72 hours postdose
干预措施: QY101 ointment or vehicle
SAD Cohort 6(1.0% QY101 ointment or vehicle apply to 40%BSA)
6 subjects use 1.0% QY101 ointment，2 subjects use vehicle topical applied to 40% Body Surface Area，assessed until 72 hours postdose
干预措施: QY101 ointment or vehicle
MAD Cohort 7(0.3% QY101 ointment or vehicle apply to 20%BSA)
6 subjects use 0.3% QY101 ointment，2 subjects use vehicle topical applied to 20% Body Surface Area，twice daily for 7 days and once in the morning on D8
干预措施: QY101 ointment or vehicle
MAD Cohort 8(0.5% QY101 ointment or vehicle apply to 20%BSA)
6 subjects use 0.5% QY101 ointment，2 subjects use vehicle topical applied to 20% Body Surface Area，twice daily for 7 days and once in the morning on D8
干预措施: QY101 ointment or vehicle
MAD Cohort 9(1.0% QY101 ointment or vehicle apply to 20%BSA)
6 subjects use 1.0% QY101 ointment，2 subjects use vehicle topical applied to 20% Body Surface Area，twice daily for 7 days and once in the morning on D8
干预措施: QY101 ointment or vehicle
MAD Cohort 10(1.0% QY101 ointment or vehicle apply to 40%BSA)
6 subjects use 1.0% QY101 ointment，2 subjects use vehicle topical applied to 40% Body Surface Area，twice daily for 7 days and once in the morning on D8
干预措施: QY101 ointment or vehicle
结局指标
主要结局
Number of Participants With Clinical Laboratory Abnormalities
时间窗: SAD：Screening period and Day4；MAD：Screening period, Day5 and Day11
Number of Participants With Clinically Significant Changes Form Baseline in Vital Signs
时间窗: SAD：Screening period and Day1 to Day4；MAD：Screening period and Day1 to Day11
Number of Participants With Clinically Significant Treatment-emergent Electrocardiogram (ECG) Findings
时间窗: SAD：Screening period and Day4；MAD：Screening period, Day5 and Day11
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: SAD：Day1 to Day18；MAD：Day1 to Day25
Severity of local skin irritation
时间窗: SAD：Day1 to Day4；MAD：Day1 to Day11
Skin irritation response assessment recording method: -: no reaction; + (mild): only erythema can be observed; + (moderate): moderate erythema, edema; + (severe): severe erythema, edema with papules, vesicles; + (severe): severe erythema, edema, bullae, and even necrosis.
Number of Participants With Clinically Significant Changes Form Baseline in Physical Examination
时间窗: SAD：Screening period and Day4；MAD：Screening period, Day5 and Day11
次要结局
- t1/2 of QY101(SAD：Day1 to Day4；MAD：Day1，Day5 to Day11)
- Cmax of QY101(SAD：Day1 to Day4；MAD：Day1，Day5 to Day11)
- AUC0-∞ of QY101(SAD：Day1 to Day4；MAD：Day1，Day5 to Day11)
- Tmax of QY101(SAD：Day1 to Day4；MAD：Day1，Day5 to Day11)