Safety IssuesPhase 1NCT04100642
A Phase I Clinical Study of Hemay808
A Phase 1 study testing Hemay808 in people with Safety Issues, run by Tianjin Hemay Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
This is a first-in-human study in health volunteers. The purpose is the local tolerability and systemic safety of Hemay808, which is an ointment made of a novel small molecule Hemay028. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety Issues
- What is being tested?
- Hemay808
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 8 Apr 2019to 22 Dec 2019
- 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
- Pediatric subjects aged ≥ 18 to 45 years, inclusive.
- Male weight 50kg during screening; Female weight 45kg; Body mass index (BMI) between 19 and 24kg/m2 (including boundary value).
- No ulceration, injury, sunburn, redness, rash, pigmentation, uneven skin color, excessive freckles or abnormal fever were found in the skin of the target coating area during screening and before administration.
- Chinese health volunteers
- Women of child-bearing age and all male subjects must undertake to take effective contraceptive measures during the study period and within 6 months after discontinuation of the medication.
- All subjects will voluntarily participate in the study after knowing the content of the study and possible adverse drug reactions (ADR), and must sign the informed consent approved by the ethics committee before starting to accept any inspection specified in this study.
- Subjects will be able to communicate well with the investigator and promise to complete the study in accordance with the study regulations.
Who cannot join
- History of mental illness or a genetic history of mental illness, or a history of serious (5.0 NCI CTCAE 3) cardiovascular, liver, kidney, digestive tract, neurological or other diseases.
- Any dermatological condition other than atopic dermatitis that in the Investigator's opinion may interfere with the evaluation of the patient's atopic dermatitis.
- History of atopic dermatitis.
- History of severe (5.0 NCI CTCAE 3) skin disease.
- Current diagnosis or history allergic disease (such as allergic nose pharynx, allergic asthma), has a history of drug allergy, always have a skin allergy (including but not limited to allergic to the patch, for metal, cosmetics and household items with contact dermatitis), known to gao min physique, or known or the judge may, the active ingredient to the study drug has allergies or accessories.
- Regular smoking (>5 / day) or drinking (>28 units/day); Unit: 285mL beer or 25mL spirits or 100mL wine); Or drink too much tea every day (>15g tea/day); Generally, each time tea is brewed (3~5g of tea), coffee or drinks containing caffeine (>500mg/ day) (one cup of coffee contains about 85mg of caffeine).
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- Subjects were not negative by virological examination (hepatitis b surface antigen, hepatitis c antibody, human immunodeficiency virus) and gelagglutination test of treponema pallidum.
- Common drugs (MDMA, MOR, MAMP, KETA) did not meet the requirements.
- Have major surgery within 2 months prior to screening, or have any surgery within 4 weeks prior to screening.
- Had treated cancer within 5 years prior to screening (except for squamous cell, basal cell, or in situ skin cancers that were cured only by cryopreservation or surgical excision).
- History of use (including topical use) for any reason within 2 weeks prior to administration. Except the investigator determines that the drug used has a half-life of >5 years after the start of this study, the corresponding subjects can also be enrolled.
- Have a history of drug abuse or drug abuse, or regularly (>3 times/week within 3 months before screening) use Chinese herbs, tranquilizers, sleeping pills, tranquilizers and other addictive drugs.
- Participated in any clinical trial within 3 months prior to screening.
- Non-physiologic blood loss 400ml (including trauma, blood collection and blood donation) within 3 months prior to screening, or blood donation during the study period or within 1 month after the study.
- The female subjects were in lactation or pregnancy at the time of screening (meaning the serum human chorionic gonadotropin test results of female subjects of child-bearing age were higher than the reference value).
- Female subjects with menstrual disorders for the last 2 months.
- Female subjects of reproductive age had unprotected sex with a heterosexual partner within 14 days prior to screening.
- Subjects of child-bearing age (male or female) plan to become pregnant during or within 6 months after the end of the study.
- Other circumstances in which the researcher considers it inappropriate to participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Dermotology hospital, Chinese academy of medical science
Nanjing, Jiangsu, 210042
About this study
Official title: A Phase I Clinical Study Assessed the Safety Tolerance and Pharmacokinetic Characteristics of Hemay808 in Healthy Adult Volunteers
This is a first-in-human study in health volunteers. The purpose is the local tolerability and systemic safety of Hemay808, which is an ointment made of a novel small molecule Hemay028. The safety and systemic pharmacokinetics (PK) of Hemay028 will be evaluated following topical application of Hemay808 to healthy volunteers.
Read the detailed description
There are two pre-test groups. Group1 use Hemay808 and placebo on sensitive areas. Group2 will only topical use Hemay808 on 5%BSA.
After 2 pre-test group, 4 formal testing groups will start. 1% Hemay808 apply to 25%BSA; 3% Hemay808 apply to 25%BSA; 3% Hemay808 apply to 55%BSA; 7% Hemay808 apply to 25%BSA. First a single doses then wash-out for three days, after that subjects will applicant twice daily for 7 days to assess the local skin tolerability, and systemic PK of these treatments.
Approximately 42 healthy adult volunteers will be enrolled in this study with 8- 10 volunteers each cohort.
- Conditions
- Safety Issues
- Being tested
- Hemay808, Placebo
- Keywords
- first in human, atopic dermatitis
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemay808Drug
topical apply
PlaceboDrug
topical apply
| Study group | Role | What they receive |
|---|---|---|
| 1% Hemay808 apply to 25%BSA | Active comparator | 8 subjects use 1% Hemay808 Receives: Drug: Hemay808 |
| 3% Hemay808 apply to 25%BSA | Experimental | 8 subjects use 3% Hemay808 Receives: Drug: Hemay808 |
| 3% Hemay808 apply to 55%BSA | Experimental | 6 subjects use 3% Hemay808 Receives: Drug: Hemay808 |
| 7% Hemay808 apply to 25%BSA | Experimental | 8 subjects use 7% Hemay808 Receives: Drug: Hemay808 |
| placebo apply to 25%BSA | Placebo comparator | 6 subjects use placebo apply to 25%BSA Receives: Drug: Placebo |
| placebo apply to 55%BSA | Placebo comparator | 2 subjects use placebo apply to 55%BSA Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events and serious adverse events.
Incidence of AEs
Measured: Day 1 to Day 30
Secondary outcomes (4)
Cmax
Maximum observed plasma concentration.
Measured: pre-dose, 0.5, 1, 2, 3, 5, 8, 12, 14, 24, 36, 48, 72 hours post-dose
Tmax
Time of maximum concentration Time of maximum concentration Time of maximum concentration Time of maximum concentration Time of maximum concentration Time of maximum concentration Time of Time of maximum concentration Time of maximim plasma concentration
Measured: pre-dose, 0.5, 1, 2, 3, 5, 8, 12, 14, 24, 36, 48, 72 hours post-dose
AUCt
Area under the plasma concentration-time curve from time zero extrapolated to infinity.
Measured: pre-dose, 0.5, 1, 2, 3, 5, 8, 12, 14, 24, 36, 48, 72 hours post-dose
AUC∞
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration.
Measured: pre-dose, 0.5, 1, 2, 3, 5, 8, 12, 14, 24, 36, 48, 72 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start8 Apr 2019
- Primary completion23 Oct 2019
- Study completion22 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies 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
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Hemay Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04100642
- Sponsor's protocol ID
- YQ-M-18-08
- Status last verified
- Sep 2019
- First submitted
- 20 May 2019
- Last updated
- 27 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study Assessed the Safety Tolerance and Pharmacokinetic Characteristics of Hemay808 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT04100642
- Acronym / sponsor ID
- YQ-M-18-08
- Conditions
- Safety Issues
- Keywords
- first in human, atopic dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Tianjin Hemay Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 23 Oct 2019 (actual)
- Study completion
- 22 Dec 2019 (actual)
- First posted
- 24 Sep 2019 (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 is a first-in-human study in health volunteers. The purpose is the local tolerability and systemic safety of Hemay808, which is an ointment made of a novel small molecule Hemay028. The safety and systemic pharmacokinetics (PK) of Hemay028 will be evaluated following topical application of Hemay808 to healthy volunteers.
Detailed description
There are two pre-test groups. Group1 use Hemay808 and placebo on sensitive areas. Group2 will only topical use Hemay808 on 5%BSA.
After 2 pre-test group, 4 formal testing groups will start. 1% Hemay808 apply to 25%BSA; 3% Hemay808 apply to 25%BSA; 3% Hemay808 apply to 55%BSA; 7% Hemay808 apply to 25%BSA. First a single doses then wash-out for three days, after that subjects will applicant twice daily for 7 days to assess the local skin tolerability, and systemic PK of these treatments.
Approximately 42 healthy adult volunteers will be enrolled in this study with 8- 10 volunteers each cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1% Hemay808 apply to 25%BSA | Active comparator | Drug: Hemay8088 subjects use 1% Hemay808 |
| 3% Hemay808 apply to 25%BSA | Experimental | Drug: Hemay8088 subjects use 3% Hemay808 |
| 3% Hemay808 apply to 55%BSA | Experimental | Drug: Hemay8086 subjects use 3% Hemay808 |
| 7% Hemay808 apply to 25%BSA | Experimental | Drug: Hemay8088 subjects use 7% Hemay808 |
| placebo apply to 25%BSA | Placebo comparator | Drug: Placebo6 subjects use placebo apply to 25%BSA |
| placebo apply to 55%BSA | Placebo comparator | Drug: Placebo2 subjects use placebo apply to 55%BSA |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Pediatric subjects aged ≥ 18 to 45 years, inclusive.
- Male weight 50kg during screening; Female weight 45kg; Body mass index (BMI) between 19 and 24kg/m2 (including boundary value).
- No ulceration, injury, sunburn, redness, rash, pigmentation, uneven skin color, excessive freckles or abnormal fever were found in the skin of the target coating area during screening and before administration.
- Chinese health volunteers
- Women of child-bearing age and all male subjects must undertake to take effective contraceptive measures during the study period and within 6 months after discontinuation of the medication.
Key exclusion criteria (19 listed)
- History of mental illness or a genetic history of mental illness, or a history of serious (5.0 NCI CTCAE 3) cardiovascular, liver, kidney, digestive tract, neurological or other diseases.
- Any dermatological condition other than atopic dermatitis that in the Investigator's opinion may interfere with the evaluation of the patient's atopic dermatitis.
- History of atopic dermatitis.
- History of severe (5.0 NCI CTCAE 3) skin disease.
- Current diagnosis or history allergic disease (such as allergic nose pharynx, allergic asthma), has a history of drug allergy, always have a skin allergy (including but not limited to allergic to the patch, for metal, cosmetics and household items with contact dermatitis), known to gao min physique, or known or the judge may, the active ingredient to the study drug has allergies or accessories.
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 |
|---|---|---|
| Hemay808topical apply | Drug | 1% Hemay808 apply to 25%BSA, 3% Hemay808 apply to 25%BSA, 3% Hemay808 apply to 55%BSA, 7% Hemay808 apply to 25%BSA |
| Placebotopical apply | Drug | placebo apply to 25%BSA, placebo apply to 55%BSA |
Primary outcome
Number of adverse events and serious adverse events.
Time frame: Day 1 to Day 30
Incidence of AEs
4 secondary outcomes
Cmax
Time frame: pre-dose, 0.5, 1, 2, 3, 5, 8, 12, 14, 24, 36, 48, 72 hours post-dose
Tmax
Time frame: pre-dose, 0.5, 1, 2, 3, 5, 8, 12, 14, 24, 36, 48, 72 hours post-dose
AUCt
Time frame: pre-dose, 0.5, 1, 2, 3, 5, 8, 12, 14, 24, 36, 48, 72 hours post-dose
AUC∞
Time frame: pre-dose, 0.5, 1, 2, 3, 5, 8, 12, 14, 24, 36, 48, 72 hours post-dose
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 27 Apr 2020.
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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.
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 Hemay808 in people with Safety Issues, run by Tianjin Hemay Pharmaceutical 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 19 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 27 Apr 2020. 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?
Number of adverse events and serious adverse events. (time frame: Day 1 to Day 30). 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 27 Apr 2020.