A Phase I Clinical Study of Hemay808

April 23, 2020 updated by: Tianjin Hemay Pharmaceutical Co., Ltd

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Jiangsu
      • Nanjing, Jiangsu, China, 210042
        • Dermotology hospital, Chinese academy of medical science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1% Hemay808 apply to 25%BSA
8 subjects use 1% Hemay808
topical apply
EXPERIMENTAL: 3% Hemay808 apply to 25%BSA
8 subjects use 3% Hemay808
topical apply
EXPERIMENTAL: 3% Hemay808 apply to 55%BSA
6 subjects use 3% Hemay808
topical apply
EXPERIMENTAL: 7% Hemay808 apply to 25%BSA
8 subjects use 7% Hemay808
topical apply
PLACEBO_COMPARATOR: placebo apply to 25%BSA
6 subjects use placebo apply to 25%BSA
topical apply
PLACEBO_COMPARATOR: placebo apply to 55%BSA
2 subjects use placebo apply to 55%BSA
topical apply

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of adverse events and serious adverse events.
Time Frame: Day 1 to Day 30
Incidence of AEs
Day 1 to Day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: pre-dose, 0.5, 1, 2, 3, 5, 8, 12, 14, 24, 36, 48, 72 hours post-dose
Maximum observed plasma concentration.
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
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
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
Area under the plasma concentration-time curve from time zero extrapolated to infinity.
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
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration.
pre-dose, 0.5, 1, 2, 3, 5, 8, 12, 14, 24, 36, 48, 72 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 8, 2019

Primary Completion (ACTUAL)

October 23, 2019

Study Completion (ACTUAL)

December 22, 2019

Study Registration Dates

First Submitted

May 20, 2019

First Submitted That Met QC Criteria

September 20, 2019

First Posted (ACTUAL)

September 24, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 27, 2020

Last Update Submitted That Met QC Criteria

April 23, 2020

Last Verified

September 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • YQ-M-18-08

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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