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PsoriasisPhase 1NCT03007810

Safety and Pharmacokinetics of Hemay005 In Healthy Male Subjects

A Phase 1 study testing Hemay005 in people with Psoriasis, run by Tianjin Hemay Bio-Tech Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Hemay005 is a novel phosphodiesterase type 4(PDE4) inhibitor being developed for the treatment of psoriasis. This study is the first administration of Hemay005 in humans to establish the initial safety, tolerability, and pharmacokinetic profile following single doses of Hemay005. Read more about this study

Who is it for?
Ages 18 to 60 years, men onlyHealthy volunteers can take part
Conditions the study is for
Psoriasis
What is being tested?
Hemay005
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
68 participants
Where
1 siteChina
Study dates
Dec 2016to Jun 2018
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 60 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male subjects aged 18 to 60 years;
  • Bodyweight（BW）≥ 50kg, Body mass index (BMI) in 18-28 (including upper and lower limit of the range);
  • 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);
  • Ability to understand and be willing to sign a written informed consent before study entry;
  • Subjects would have good communication with the investigator and could comply with protocol.

Who cannot join

  • A history of clinically severe gastrointestinal, hepatic, renal, cardiovascular, dermatological, immunological, respiratory, endocrine, oncological, neurological, metabolic, psychiatric disease or haematological disorders;
  • 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;
  • Have a gastrointestinal, hepatic or renal condition that may influence drug absorption or metabolism;
  • A history of chronic infection (ie, tuberculosis);
  • A medical history of any clinically significant medical disease or surgery within 4 weeks of the screening;
  • Clinically significant laboratory abnormal results at screening or prior to the first dose of study drug;
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  • Clinically significant abnormal 12-lead ECG or vital signs ( systolic pressure <90 mmHg or >140 mmHg, diastolic pressure <50 mmHg or >90 mmHg; radial pulse rate <50 bpm or >100 bpm);
  • Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, or hepatitis C virus antibody at screening;
  • Recent history 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;
  • Positive urine screen for drug and cigarettes, positive breath test for alcohol;
  • 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;
  • Dietary habits or food intolerances which will interfere with the requirements for participants to consume a standardised diet whilst confined to the clinical unit;
  • 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;
  • 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, glucocorticoid and omeprazole; inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones and antihistamines);
  • Participant who received any medicine within 14 days of the initial dose of study drug;
  • Have received other clinical trials treatment within 3 months prior to study;
  • 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;
  • Subjects cannot complete the study due to other reasons or by the investigator's judgment

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking Union Medical College Hospital

    Beijin

Other trials in China

About this study

Official title: An Ascending Single Dose Study of the Pharmacokinetics, Safety and Tolerability of Hemay005 in Healthy Male Subjects

Hemay005 is a novel phosphodiesterase type 4(PDE4) inhibitor being developed for the treatment of psoriasis. This study is the first administration of Hemay005 in humans to establish the initial safety, tolerability, and pharmacokinetic profile following single doses of Hemay005. A total of approximately 44 subjects will be randomized into 6 cohorts(10mg, 20mg, 40mg, 80mg, 120mg, 180mg), approximately 8 healthy subjects will be enrolled (6 active and 2 placebo) at each dose cohort by sentinel method(1 active and 1 placebo,5 active and 1 placebo), with the exception of 10mg (4 active) cohort. This study includes an 28-day Screening Period, a 1-day Treatment Period, and an End of Study Visit occurring approximately 11days (±3 days) after study drug administration.

Conditions
Psoriasis
Being tested
Hemay005, Placebos
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hemay005Drug

    Subjects will be randomized into 6 cohorts(10mg, 20mg, 40mg, 80mg, 120mg, 180mg) orally single dose

  • PlacebosDrug

    Subjects will be randomized into 5 cohorts(20mg, 40mg, 80mg, 120mg, 180mg) orally single dose

Study groups in NCT03007810
Study groupRoleWhat they receive
Hemay005ExperimentalFour subjects in cohort 1 and six subjects in each cohort (2 to 6) will receive Hemay005.
Receives: Drug: Hemay005
PlaceboPlacebo comparatorTwo subjects in each cohort (cohorts 2 to 6) will receive placebo.
Receives: Drug: Placebos

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of adverse events and serious adverse events

    Measured: Day 1 up to Day 11±3

Secondary outcomes (10)

  1. Cmax

    Maximum observed plasma concentration

    Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose

  2. Tmax

    Time of maximum concentration

    Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose

  3. AUCt

    Area under the plasma concentration-time curve from time zero extrapolated to infinity

    Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose

  4. AUC∞

    Area under the plasma concentration-time curve from time zero to the last quantifiable concentration

    Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose

  5. t1/2

    Terminal elimination half-life

    Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose

  6. CL/F

    Apparent total plasma clearance

    Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose

  7. Vz/F

    Apparent total volume of distribution

    Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose

  8. Cumulative urinary excretion

    Measured: pre-dose, 0-4 hours，4-8 hours，8-12 hours，12-24 hours，24-36 hours，36-48 hours post-dose

  9. Accumulative urine excretion rate

    Measured: pre-dose, 0-4 hours，4-8 hours，8-12 hours，12-24 hours，24-36 hours，36-48 hours post-dose

  10. Renal clearance

    Measured: pre-dose, 0-4 hours，4-8 hours，8-12 hours，12-24 hours，24-36 hours，36-48 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2017 (estimated)
  2. Study startDec 2016
  3. Primary completionJun 2018
  4. Study completionJun 2018

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03007810
Sponsor's protocol ID
HM005PS1S01
Status last verified
Jun 2018
First submitted
22 Dec 2016
Last updated
19 Jun 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Li X, Wu X, Huo A, Zeng G, Jones R, Chen R, Wang H. Safety, Tolerability, and Pharmacokinetics of Mufemilast, a PDE4 Inhibitor, in Healthy Participants: A First-in-Human Phase 1 Study. Clin Pharmacol Drug Dev. 2026 Jan;15(1):e70005. doi: 10.1002/cpdd.70005.

    PubMed 41545329

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Hemay005 in people with Psoriasis, run by Tianjin Hemay Bio-Tech 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 5 inclusion and 18 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 19 Jun 2018. 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 up to Day 11±3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03007810, which also lists 1 linked publication.

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 19 Jun 2018.

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