Preoperative Sedation of AdultsPhase 1NCT07098117
A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety and Pharmacokinetic Profile of Single and Multiple Dose Escalation Topical Dermal Administration of SHR0302 Alkali Gel in Healthy Subjects
A Phase 1 study testing SHR0302 Base Gel in people with Preoperative Sedation of Adults, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This study is divided into two parts, the first part is a single-dose dose escalation trial (SAD) in healthy subjects; The second part is a multiple-dose dose escalation trial (MAD) in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Preoperative Sedation of Adults
- What is being tested?
- SHR0302 Base Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 19 Jun 2024to 31 Jul 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sign the informed consent form before the trial, fully understand the content, process and possible adverse reactions of the trial, and be able to complete the study according to the requirements of the trial protocol.
- Must be ≥ 18 years old and ≤ 55 years old on the day of signing the informed consent form, male or female;
- Male subjects weigh ≥ 50 kg, female subjects weigh ≥ 45 kg, and body mass index (BMI) within the range of 18.0~28.0 kg/m2 (including boundary values);
- Subjects and their partners have no birth plan, do not donate sperm/eggs, and voluntarily take highly effective contraceptive measures (see Appendix 11 for specific contraceptive measures) from the study period to 6 months (female subjects) or 3 months (male subjects) after dosing, and the serum pregnancy test for female subjects must be negative and non-lactating.
Who cannot join
- Those who have had or are currently suffering from any clinically serious diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, blood system, immune system, psychiatric and metabolic abnormalities, or any other diseases that may interfere with the results of the trial in the judgment of the investigator;
- In the opinion of the investigator, the subject has skin lesions or abnormalities that may affect the evaluation of the study drug administration site, such as dermatitis, tattoos, scars, excessive hair, birthmarks, injuries, uneven skin tone, sunburn, etc.;
- Subjects have skin diseases that may affect the evaluation at the site of administration, such as vitiligo, eczema, acne, atopic dermatitis, dysplastic moles, or other skin lesions, or a history of skin cancer;
- Those who have had serious infection, severe trauma or major surgical surgery within 6 months before screening; Those who plan to undergo surgery during the trial and within 2 weeks of the end;
- Positive hepatitis B virus surface antigen (HBsAg), human immunodeficiency virus antibody (HIV-Ab), Treponema pallidum antibody, and hepatitis C virus antibody (HCV-Ab) during the screening period;
- Estimated glomerular filtration rate (eGFR) calculated by the Dietary Modification for Nephrology (MDRD) formula (see Appendix 2) < 90 mL/min/1.73 m² at screening, or serum creatinine exceeding the normal range, and judged by the investigator to be clinically significant and not suitable for participation in this investigator;
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- Suspected allergy to the test drug or any ingredient in the test drug;
- Abnormal vital signs, physical examination, laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function), chest stereotype, abdominal ultrasound and 12-lead electrocardiogram at screening and judged by the investigator to be unsuitable for participation in this study;
- Screening or baseline 12-lead ECG QTcF>450 ms and abnormal clinically significant as judged by the investigator;
- Screening or baseline systolic blood pressure ≥ 140 mmHg or < 90 mmHg; Diastolic blood pressure ≥ 90 mmHg or < 60 mmHg, and abnormal clinically significant as judged by the investigator;
- Subjects who have a test result of 1.5 times the upper limit of normal (ULN) > any of the test results of alanine aminotransferase (ALT), or aspartate aminotransferase (AST), or total bilirubin (TBIL) at screening or baseline;
- Those who have used any drugs within 2 weeks before the first use of the investigational drug or those who have used the drug for less than 5 half-lives (whichever is longer), and those who plan to use any other drugs during the study, including prescription drugs, over-the-counter drugs, Chinese herbal medicines and food supplements (except oral contraceptives), etc.;
- The subject has any conditions or diseases that affect the absorption, metabolism and/or excretion of the trial drug as judged by the investigator;
- Those who have participated in any clinical trial of any drug or medical device within 3 months before screening, or who are within 5 half-lives of the drug before screening (if the 5 half-lives exceed 3 months, whichever is longer); Participants in clinical trials are defined as: informed consent from clinical trials, and have used investigational drugs (including placebos) or experimental medical devices;
- Those who have received live (attenuated) vaccines 1 month before screening or plan to receive live (attenuated) vaccines during the trial;
- Total blood donation or blood loss ≥ 200 mL within 1 month prior to screening, or total blood donation or blood loss ≥ 400 mL within 3 months prior to screening; or those who have received blood transfusion within 2 months; or those who have difficulty in venous blood collection, or whose physical condition cannot bear intensive blood collection;
- Those who have a history of smoking in the 3 months before screening (smoking > 5 cigarettes per day);
- Alcoholics (drinking 14 units of alcohol per week [1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine]) or positive alcohol breath test at baseline within 3 months prior to screening;
- Those who cannot abstain from smoking, alcohol and caffeinated food or beverages 2 days before and during the study of the investigational drug; and those who have special requirements for diet and cannot comply with the unified diet;
- Those with a history of drug abuse, drug dependence, or positive drug screen at baseline;
- Pregnant or lactating women, pregnancy is defined as female status after pregnancy to before termination of pregnancy and positive blood β-HCG test at screening;
- Have any situation that may cause the subject to be unable to complete this study or pose obvious risks to the subject or other factors that reduce the possibility of enrollment (such as frailty, mental illness, etc.);
- Researchers and relevant staff of the research center or other people directly involved in the implementation of the program.
Trial locations and contacts
1 site in 1 country.
About this study
This study is divided into two parts, the first part is a single-dose dose escalation trial (SAD) in healthy subjects; The second part is a multiple-dose dose escalation trial (MAD) in healthy subjects.
- Conditions
- Preoperative Sedation of Adults
- Being tested
- SHR0302 Base Gel, SHR0302 Base Gel Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR0302 Base GelDrug
Part I: once daily. Part 2:, twice daily.
SHR0302 Base Gel PlaceboDrug
Part I: once daily. Part II: twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 :SHR0302 Base Gel | Experimental | Not described Receives: Drug: SHR0302 Base Gel |
| Group2: SHR0302 Base Gel Placebo | Placebo comparator | Not described Receives: Drug: SHR0302 Base Gel Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1, Skin local tolerability was assessed as moderate and above incidence, adverse events
Measured: 8days
Part 2, Skin local tolerability was assessed as moderate and above incidence, adverse events
Measured: 2weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start19 Jun 2024
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative Sedation of AdultsStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07098117
- Sponsor's protocol ID
- SHR0302Base-101
- Status last verified
- Jul 2025
- First submitted
- 27 Jul 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety and Pharmacokinetic Profile of Single and Multiple Dose Escalation Topical Dermal Administration of SHR0302 Alkali Gel in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07098117
- Acronym / sponsor ID
- SHR0302Base-101
- Conditions
- Preoperative Sedation of Adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Jun 2024 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 1 Aug 2025 (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.
This study is divided into two parts, the first part is a single-dose dose escalation trial (SAD) in healthy subjects; The second part is a multiple-dose dose escalation trial (MAD) in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 :SHR0302 Base Gel | Experimental | Drug: SHR0302 Base Gel |
| Group2: SHR0302 Base Gel Placebo | Placebo comparator | Drug: SHR0302 Base Gel Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Sign the informed consent form before the trial, fully understand the content, process and possible adverse reactions of the trial, and be able to complete the study according to the requirements of the trial protocol.
- Must be ≥ 18 years old and ≤ 55 years old on the day of signing the informed consent form, male or female;
- Male subjects weigh ≥ 50 kg, female subjects weigh ≥ 45 kg, and body mass index (BMI) within the range of 18.0~28.0 kg/m2 (including boundary values);
- Subjects and their partners have no birth plan, do not donate sperm/eggs, and voluntarily take highly effective contraceptive measures (see Appendix 11 for specific contraceptive measures) from the study period to 6 months (female subjects) or 3 months (male subjects) after dosing, and the serum pregnancy test for female subjects must be negative and non-lactating.
Key exclusion criteria (23 listed)
- Those who have had or are currently suffering from any clinically serious diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, blood system, immune system, psychiatric and metabolic abnormalities, or any other diseases that may interfere with the results of the trial in the judgment of the investigator;
- In the opinion of the investigator, the subject has skin lesions or abnormalities that may affect the evaluation of the study drug administration site, such as dermatitis, tattoos, scars, excessive hair, birthmarks, injuries, uneven skin tone, sunburn, etc.;
- Subjects have skin diseases that may affect the evaluation at the site of administration, such as vitiligo, eczema, acne, atopic dermatitis, dysplastic moles, or other skin lesions, or a history of skin cancer;
- Those who have had serious infection, severe trauma or major surgical surgery within 6 months before screening; Those who plan to undergo surgery during the trial and within 2 weeks of the end;
- Positive hepatitis B virus surface antigen (HBsAg), human immunodeficiency virus antibody (HIV-Ab), Treponema pallidum antibody, and hepatitis C virus antibody (HCV-Ab) during the screening period;
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 |
|---|---|---|
| SHR0302 Base GelPart I: once daily. Part 2:, twice daily. | Drug | Group 1 :SHR0302 Base Gel |
| SHR0302 Base Gel PlaceboPart I: once daily. Part II: twice daily. | Drug | Group2: SHR0302 Base Gel Placebo |
Primary outcome
Part 1, Skin local tolerability was assessed as moderate and above incidence, adverse events
Time frame: 8days
Part 2, Skin local tolerability was assessed as moderate and above incidence, adverse events
Time frame: 2weeks
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 1 Aug 2025.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
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 testing SHR0302 Base Gel in people with Preoperative Sedation of Adults, run by Jiangsu HengRui Medicine 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 4 inclusion and 23 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 1 Aug 2025. 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. Some participants in this study may receive a placebo. 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?
Part 1, Skin local tolerability was assessed as moderate and above incidence, adverse events (time frame: 8days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2025; AzTrials last refreshed its copy on 31 Oct 2026.