Loading clinical trials...

Multiple Ascending Dose Study to Assess Safety and Pharmacokinetics of Hemay005 In Healthy Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Multiple Ascending Dose Study to Assess Safety and Pharmacokinetics of Hemay005 In Healthy Subjects

Clinical Study of Safety, Tolerability, and Pharmacokinetics of Hemay005 Tablets in Single and Multiple Doses in Healthy Subjects

NCT04837235•Tianjin Hemay Pharmaceutical Co., Ltd

View on ClinicalTrials.gov

Summary

Hemay005 is a novel phosphodiesterase type 4(PDE4) inhibitor being developed for the treatment of psoriasis. There were 3 dose cohorts (75mg, 90mg, 105mg) with 12 healthy subjects in each cohorts (6 males and 6 females). This study includes an 11-day Screening Period, a 1-day single dose and 7-days multiple doses Treatment Period.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. healthy subjects aged 18 to 60 years, The ratio of male to female is 1:1
•2. male Bodyweight（BW）≥ 50kg, female Bodyweight（BW）≥ 45kg, Body mass index (BMI) in 18-28 (including upper and lower limit of the range);
•3. All male subjects must agree and commit to the use of a reliable contraceptive regimen(including vasoligation, abstinence, using a condom) for the duration of the study(from screening until 6 months after the last dose), Female participants with a negative pregnancy test (serum) at both the screening visit and at Day-1, Female subjects and female partners of male subjects must agree and commit to the use of a reliable contraceptive regimen ( oral contraceptive medications or non-oral contraceptive medications) for the duration of the study(from screening until 6 months after the last dose);
•4. Ability to understand and be willing to sign a written informed consent before study entry;
•5. Subjects would have good communication with the investigator and could comply with protocol.

Exclusion Criteria

•1. A history of clinically severe gastrointestinal, hepatic, renal, cardiovascular, dermatological, immunological, respiratory, endocrine, oncological, neurological, metabolic, psychiatric disease or haematological disorders;
•2. Have a known history of hypersensitivity to any medicine or food, or allergy to the test article or any of the excipient of the test article;
•3. Those who have or are suffering from gastrointestinal, liver and kidney diseases that affect drug absorption or metabolism
•4. A history of chronic infection (ie, tuberculosis);
•5. A medical history of any clinically significant medical disease or surgery within 4 weeks of the screening
•6. Clinically significant laboratory abnormal results at screening or prior to the first dose of study drug;
•7. Clinically significant abnormal 12-lead ECG or vital signs
•8. Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, hepatitis C virus antibody or Treponema pallidum antibody at screening;
•9. Within 1 year before study enrollment of frequent alcohol consumption, defined by average intake of greater than 14 units of alcohol per week (1 unit = 360 mL beer or 45 mL of spirits with 40% alcohol content, or 150 mL wine), Participants who are unable to abstain from smoking during the study or quitting smoking for less than 3 months;
•10. Positive urine screen for drug and cigarettes, positive breath test for alcohol;
+9 more criteria

Locations (1)

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Guangzhou, China

Key Dates

Start Date

April 29, 2021

Primary Completion Date

August 1, 2021

Completion Date

August 25, 2021

Last Updated

March 6, 2024

Enrollment

ACTUAL participants

Conditions

Psoriasis

Interventions

Hemay005

DRUG

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

NCT07449234

Psoriasis

View study

RECRUITINGPHASE3

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

NCT07116967

Plaque Psoriasis

View study

RECRUITINGPHASE3

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

NCT07250802

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 6, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Multiple Ascending Dose Study to Assess Safety and Pharmacokinetics of Hemay005 In Healthy Subjects

Inclusion Criteria

Exclusion Criteria

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments