ClinicalTrials.gg
CompletedNCT04837235Hemay005Updated Mar 6, 2024

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

A Phase 1 interventional study of Hemay005 in Psoriasis, sponsored by Tianjin Hemay Pharmaceutical Co., Ltd. Completed at 1 site in China. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-06.

Sponsored by Tianjin Hemay Pharmaceutical Co., Ltd · Phase 1, Interventional, and Treatment

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Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 10 studies testing Hemay005 in Psoriasis — 1 open to participants now, 1 under way, none of them phase 3. Hemay005 · Psoriasis.

Enrollment
9th of 10
12 · median 25
Started
2021
the only one that year
Phase 1
8 of 10
1 open now
Registered
6th of 10
by date
Lead sponsor
3 of 10
Tianjin Hemay Pharmaceutical Co., Ltd

Among the 10 studies testing Hemay005 in Psoriasis, this one is the 9th largest by enrollment, is the only one that started in 2021, is one of 8 in phase 1, and was the 6th registered.

Psoriasis

2,030 studies on the registry are indexed under Psoriasis; 276 are open to participants now.

Browse Psoriasis studies →

Open to participants now

1 of the 10 studies testing Hemay005 in Psoriasis is open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

Where they have run

About Hemay005

No approval found in the FDA or EMA files read. How studies give it is on its page →

Who these studies take

Of the 173 Psoriasis studies recruiting now, 91 (53%) set no upper age limit and 66 (38%) stop at 75 or younger; 25 take children under 18; 40 take healthy volunteers.

This study: 18 Years to 60 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 10 studies testing Hemay005 in Psoriasis, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Psoriasis

Browse trials for

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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, (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 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 before study entry;
  5. Subjects would have good communication with the investigator and could comply with protocol.

Exclusion criteria

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 to any medicine or food, or allergy to the test article or any of the 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 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 or vital signs
  8. Positive blood screen for (HIV antibody), virus surface antigen, 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;
  11. Subjects who use soft drugs (ie marijuana )within 3 months of the screening and entire study duration or hard drugs (ie cocaine, phencyclidine ) within 1 year of the screening and entire study duration;
  12. Dietary habits or food intolerances which will interfere with the requirements for participants to consume a standardised diet whilst confined to the clinical unit;
  13. Participants who eat special food (Including grapefruit and/or Xanthine diet) for 14 days prior to dosing or any caffeine containing food or drinks, i.e. chocolate for 48 hours prior to dosing or drinking alcohol for 24 hours prior to dosing and not will stop to intake above food and drinks;
  14. Use of any drug that inhibits or induces hepatic metabolism of drugs within 30 days of planned study drug administration and entire study duration (e.g. inducers: barbiturates, carbamazepine, rifampicin, phenytoin, and omeprazole; inhibitors-SSRI(Selective serotonin reuptake inhibitors) antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones and antihistamines);
  15. Participant who received any medicine within 14 days of the initial dose of study drug;
  16. Have received other clinical trials treatment within 3 months prior to study;
  17. Participants who have donated of blood (>400 mL) within 4 weeks of the study, or plan to donate of blood during of the study and 4 weeks after the study;
  18. Subjects cannot complete the study due to other reasons or by the investigator's judgment;
  19. Pregnancy or lactating females
Terms in these criteria, in plain language(11)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    75mg group

    15mg/tablet. Five tablets (75mg) each time. Participants will receive a single dose of Hemay005 tablet in Day 1 followed by twice a day of Hemay005 tablet in Day 3\~Day8 and single dose in Day9.

    Drug: Hemay005

  • Experimental
    90mg group

    15mg/tablet. Six tablets (90mg) each time. Participants will receive a single dose of Hemay005 tablet in Day 1 followed by twice a day of Hemay005 tablet in Day 3\~Day8 and single dose in Day9.

    Drug: Hemay005

  • Experimental
    105mg group

    15mg/tablet. Seven tablets (105mg) each time. Participants will receive a single dose of Hemay005 tablet in Day 1 followed by twice a day of Hemay005 tablet in Day 3\~Day8 and single dose in Day9.

    Drug: Hemay005

Interventions

06

What researchers measure

Primary outcomes

  1. Number of adverse events (AEs), related AEs and serious AEs (SAEs)

    All subjects who receive the drug will be analyzed for safety, and the safety evaluation will refer to CTCAE 5.0 standard.

    Time frame: From Day 1 to Day 11

07

Study locations

1 site
  • Sun Yat-sen Memorial Hospital of Sun Yat-sen University
    Guangzhou, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2021 to primary completion in Aug 2021, 3 months.

Of 137 industry-sponsored phase 1 interventional studies under Psoriasis, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 16. This study's 3 months is below that.

Counting every sponsor, half of 155 studies reached it within 10 months; a quarter within 5 and three quarters within 17.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 7, 2021
First posted
Apr 8, 2021
StartActual
Apr 29, 2021
Primary completionActual
Aug 1, 2021
CompletionActual
Aug 25, 2021
Last update
Mar 6, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04837235
Lead sponsor
Tianjin Hemay Pharmaceutical Co., Ltd
Responsible party
Sponsor
First posted
Apr 8, 2021
Start date
Apr 29, 2021
Primary completion
Aug 1, 2021
Completion
Aug 25, 2021
Last update
Mar 6, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Hemay005

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