Healthy VolunteerPhase 1NCT05429177

A First-in-Human Study of QY101 Ointment in Adult Subjects

A Phase 1 study of Healthy Volunteer, run by E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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 Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteer
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 77 participants
Where: 1 siteChina
Study dates: 8 Jun 2022to 21 Jun 2023
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Show all 15Show fewer

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.
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.
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.
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.
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.
Subjects determined by other researchers to be unfit to participate.

Trial locations and contacts

1 site in 1 country.

China1 site

The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou

Other trials in China

About this study

Official title: This is a Phase I, Randomized, Double-blind, Vehicle-controlled Study of QY101 Ointment in Chinese Healthy Subjects

Conditions: Healthy Volunteer
Being tested: QY101 ointment or vehicle

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

QY101 ointment or vehicleDrug
QY101 ointment or vehicl topical applied to skin

Study groups in NCT05429177
Study group	Role	What they receive
SAD Cohort 1(0.1% QY101 ointment or vehicle apply to 5%BSA)	Experimental	3 subjects use 0.1% QY101 ointment，1 subject uses vehicle topical applied to 5% Body Surface Area，assessed until 72 hours postdose Receives: Drug: QY101 ointment or vehicle
SAD Cohort 2(0.1% QY101 ointment or vehicle apply to 20%BSA)	Experimental	6 subjects use 0.1% QY101 ointment，2 subjects use vehicle topical applied to 20% Body Surface Area，assessed until 72 hours postdose Receives: Drug: QY101 ointment or vehicle
SAD Cohort 3(0.3% QY101 ointment or vehicle apply to 20%BSA)	Experimental	6 subjects use 0.3% QY101 ointment，2 subjects use vehicle topical applied to 20% Body Surface Area，assessed until 72 hours postdose Receives: Drug: QY101 ointment or vehicle
SAD Cohort 4(0.5% QY101 ointment or vehicle apply to 20%BSA)	Experimental	6 subjects use 0.5% QY101 ointment，2 subjects use vehicle topical applied to 20% Body Surface Area，assessed until 72 hours postdose Receives: Drug: QY101 ointment or vehicle
SAD Cohort 5(1.0% QY101 ointment or vehicle apply to 20%BSA)	Experimental	6 subjects use 1.0% QY101 ointment，2 subjects use vehicle topical applied to 20% Body Surface Area，assessed until 72 hours postdose Receives: Drug: QY101 ointment or vehicle
SAD Cohort 6(1.0% QY101 ointment or vehicle apply to 40%BSA)	Experimental	6 subjects use 1.0% QY101 ointment，2 subjects use vehicle topical applied to 40% Body Surface Area，assessed until 72 hours postdose Receives: Drug: QY101 ointment or vehicle
MAD Cohort 7(0.3% QY101 ointment or vehicle apply to 20%BSA)	Experimental	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 Receives: Drug: QY101 ointment or vehicle
MAD Cohort 8(0.5% QY101 ointment or vehicle apply to 20%BSA)	Experimental	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 Receives: Drug: QY101 ointment or vehicle
MAD Cohort 9(1.0% QY101 ointment or vehicle apply to 20%BSA)	Experimental	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 Receives: Drug: QY101 ointment or vehicle
MAD Cohort 10(1.0% QY101 ointment or vehicle apply to 40%BSA)	Experimental	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 Receives: Drug: QY101 ointment or vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: SAD：Day1 to Day18；MAD：Day1 to Day25
Number of Participants With Clinical Laboratory Abnormalities
Measured: SAD：Screening period and Day4；MAD：Screening period, Day5 and Day11
Number of Participants With Clinically Significant Changes Form Baseline in Vital Signs
Measured: SAD：Screening period and Day1 to Day4；MAD：Screening period and Day1 to Day11
Severity of local skin irritation
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.
Measured: SAD：Day1 to Day4；MAD：Day1 to Day11
Number of Participants With Clinically Significant Treatment-emergent Electrocardiogram (ECG) Findings
Measured: SAD：Screening period and Day4；MAD：Screening period, Day5 and Day11
Number of Participants With Clinically Significant Changes Form Baseline in Physical Examination
Measured: SAD：Screening period and Day4；MAD：Screening period, Day5 and Day11

Secondary outcomes (4)

Tmax of QY101
Time of maximum concentration
Measured: SAD：Day1 to Day4；MAD：Day1，Day5 to Day11
Cmax of QY101
Maximum observed plasma concentration
Measured: SAD：Day1 to Day4；MAD：Day1，Day5 to Day11
t1/2 of QY101
The time it takes for the blood concentration of the drug to drop by half from the highest value in the body
Measured: SAD：Day1 to Day4；MAD：Day1，Day5 to Day11
AUC0-∞ of QY101
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration
Measured: SAD：Day1 to Day4；MAD：Day1，Day5 to Day11

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jun 202221 Jun 2023

First posted23 Jun 2022
Study start8 Jun 2022
Primary completion21 Jun 2023
Study completion21 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 77 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05429177
Sponsor's protocol ID: QY101-Ⅰ-1
Status last verified: Jun 2022
First submitted: 8 Jun 2022
Last updated: 25 Sep 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: This is a Phase I, Randomized, Double-blind, Vehicle-controlled Study of QY101 Ointment in Chinese Healthy Subjects
ClinicalTrials.gov ID: NCT05429177
Acronym / sponsor ID: QY101-Ⅰ-1
Conditions: Healthy Volunteer
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 77 participants (actual)
Lead sponsor: E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd.Industry (pharma, biotech, devices)
Study start: 8 Jun 2022 (actual)
Primary completion: 21 Jun 2023 (actual)
Study completion: 21 Jun 2023 (actual)
First posted: 23 Jun 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 10

Arm	Type	Receives
SAD Cohort 1(0.1% QY101 ointment or vehicle apply to 5%BSA)	Experimental	Drug: QY101 ointment or vehicle3 subjects use 0.1% QY101 ointment，1 subject uses vehicle topical applied to 5% Body Surface Area，assessed until 72 hours postdose
SAD Cohort 2(0.1% QY101 ointment or vehicle apply to 20%BSA)	Experimental	Drug: QY101 ointment or vehicle6 subjects use 0.1% QY101 ointment，2 subjects use vehicle topical applied to 20% Body Surface Area，assessed until 72 hours postdose
SAD Cohort 3(0.3% QY101 ointment or vehicle apply to 20%BSA)	Experimental	Drug: QY101 ointment or vehicle6 subjects use 0.3% QY101 ointment，2 subjects use vehicle topical applied to 20% Body Surface Area，assessed until 72 hours postdose
SAD Cohort 4(0.5% QY101 ointment or vehicle apply to 20%BSA)	Experimental	Drug: QY101 ointment or vehicle6 subjects use 0.5% QY101 ointment，2 subjects use vehicle topical applied to 20% Body Surface Area，assessed until 72 hours postdose
SAD Cohort 5(1.0% QY101 ointment or vehicle apply to 20%BSA)	Experimental	Drug: QY101 ointment or vehicle6 subjects use 1.0% QY101 ointment，2 subjects use vehicle topical applied to 20% Body Surface Area，assessed until 72 hours postdose
SAD Cohort 6(1.0% QY101 ointment or vehicle apply to 40%BSA)	Experimental	Drug: QY101 ointment or vehicle6 subjects use 1.0% QY101 ointment，2 subjects use vehicle topical applied to 40% Body Surface Area，assessed until 72 hours postdose
MAD Cohort 7(0.3% QY101 ointment or vehicle apply to 20%BSA)	Experimental	Drug: QY101 ointment or vehicle6 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
MAD Cohort 8(0.5% QY101 ointment or vehicle apply to 20%BSA)	Experimental	Drug: QY101 ointment or vehicle6 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
MAD Cohort 9(1.0% QY101 ointment or vehicle apply to 20%BSA)	Experimental	Drug: QY101 ointment or vehicle6 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
MAD Cohort 10(1.0% QY101 ointment or vehicle apply to 40%BSA)	Experimental	Drug: QY101 ointment or vehicle6 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

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (15 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
QY101 ointment or vehicleQY101 ointment or vehicl topical applied to skin	Drug	MAD Cohort 10(1.0% QY101 ointment or vehicle apply to 40%BSA), MAD Cohort 7(0.3% QY101 ointment or vehicle apply to 20%BSA), MAD Cohort 8(0.5% QY101 ointment or vehicle apply to 20%BSA), MAD Cohort 9(1.0% QY101 ointment or vehicle apply to 20%BSA), SAD Cohort 1(0.1% QY101 ointment or vehicle apply to 5%BSA), SAD Cohort 2(0.1% QY101 ointment or vehicle apply to 20%BSA), SAD Cohort 3(0.3% QY101 ointment or vehicle apply to 20%BSA), SAD Cohort 4(0.5% QY101 ointment or vehicle apply to 20%BSA), SAD Cohort 5(1.0% QY101 ointment or vehicle apply to 20%BSA), SAD Cohort 6(1.0% QY101 ointment or vehicle apply to 40%BSA)

Primary outcome

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: SAD：Day1 to Day18；MAD：Day1 to Day25
Number of Participants With Clinical Laboratory Abnormalities
Time frame: SAD：Screening period and Day4；MAD：Screening period, Day5 and Day11
Number of Participants With Clinically Significant Changes Form Baseline in Vital Signs
Time frame: SAD：Screening period and Day1 to Day4；MAD：Screening period and Day1 to Day11
Severity of local skin irritation
Time frame: 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 Treatment-emergent Electrocardiogram (ECG) Findings
Time frame: SAD：Screening period and Day4；MAD：Screening period, Day5 and Day11
Number of Participants With Clinically Significant Changes Form Baseline in Physical Examination
Time frame: SAD：Screening period and Day4；MAD：Screening period, Day5 and Day11

4 secondary outcomes

Tmax of QY101
Time frame: SAD：Day1 to Day4；MAD：Day1，Day5 to Day11
Cmax of QY101
Time frame: SAD：Day1 to Day4；MAD：Day1，Day5 to Day11
t1/2 of QY101
Time frame: SAD：Day1 to Day4；MAD：Day1，Day5 to Day11
AUC0-∞ of QY101
Time frame: SAD：Day1 to Day4；MAD：Day1，Day5 to Day11

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

zourong ruan principal investigator

Second Affiliated Hospital, Zhejiang University, School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study of Healthy Volunteer, run by E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: SAD：Day1 to Day18；MAD：Day1 to Day25). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05429177.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023.