Clinical trial NCT05429177: A First-in-Human Study of QY101 Ointment in Adult Subjects
Official title: This is a Phase I, Randomized, Double-blind, Vehicle-controlled Study of QY101 Ointment in Chinese Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-06-23
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Male and female subjects aged 18 to 45 (including 18 and 45).
3. 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).
4. 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.
5. 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.
6. 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.
7. The subjects were able to communicate well with the researchers and understand and comply with the requirements of this study.

Exclusion Criteria:

1. 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.
2. 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.
3. 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.
4. Subjects who cannot tolerate venipuncture, have a history of dizzy needles and blood sickness.
5. Subjects with a history of severe skin disease (subject to the judgment of the researcher).
6. Live (attenuated) vaccine was vaccinated within 2 months before screening.
7. 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).
8. Screen subjects who have participated in other drug clinical trials or have not come to participate in clinical trials within the first 3 months.
9. 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.
10. The subjects (female) are lactating.
11. Strong inhibitors or inducers of CYP3A liver metabolic enzymes were used in the previous 2 weeks (see Appendix 2 for details), or any drugs, including prescription, over-the-counter and herbal medicines, were used for oral or topical use, except vitamins and / or paracetamol.
12. To screen subjects who drank too much tea, coffee and / or caffeinated beverages (more than 8 cups, 1 cup = 250mL) every day for the first 3 months.
13. Subjects with abnormal vital signs were included in the standard reference range (including critical value): sitting systolic blood pressure 90\~139mmHg, diastolic blood pressure 55-89mmHg, pulse 55-100bpm, body temperature 36.037.4C, breathing 12-22bpm; if the subject's first examination result is abnormal, retest can be carried out after rest.
14. There are tattoos, birthmarks, sunburns, abrasions, ulcers, erythema, dryness, scabs and scars in the target area (back, abdomen and lower limbs from thigh to calf) of the subjects.
15. Subjects determined by other researchers to be unfit to participate.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: SAD：Day1 to Day18；MAD：Day1 to Day25
measure: Number of Participants With Clinical Laboratory Abnormalities
timeFrame: SAD：Screening period and Day4；MAD：Screening period, Day5 and Day11
measure: Number of Participants With Clinically Significant Changes Form Baseline in Vital Signs
timeFrame: SAD：Screening period and Day1 to Day4；MAD：Screening period and Day1 to Day11
measure: Severity of local skin irritation
timeFrame: SAD：Day1 to Day4；MAD：Day1 to Day11
measure: Number of Participants With Clinically Significant Treatment-emergent Electrocardiogram (ECG) Findings
timeFrame: SAD：Screening period and Day4；MAD：Screening period, Day5 and Day11
measure: Number of Participants With Clinically Significant Changes Form Baseline in Physical Examination
timeFrame: SAD：Screening period and Day4；MAD：Screening period, Day5 and Day11
Secondary outcomes:
measure: Tmax of QY101
timeFrame: SAD：Day1 to Day4；MAD：Day1，Day5 to Day11
measure: Cmax of QY101
timeFrame: SAD：Day1 to Day4；MAD：Day1，Day5 to Day11
measure: t1/2 of QY101
timeFrame: SAD：Day1 to Day4；MAD：Day1，Day5 to Day11
measure: AUC0-∞ of QY101
timeFrame: SAD：Day1 to Day4；MAD：Day1，Day5 to Day11
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: zourong ruan
role: PRINCIPAL_INVESTIGATOR
References: