PsoriasisPhase 1NCT03577626
A Food Effect Study to Assess Pharmacokinetics of Hemay005 in Healthy Volunteers
A Phase 1 study testing Hemay005 in people with Psoriasis, run by Tianjin Hemay Bio-Tech Co., Ltd.
Trial summary
The purpose of this study is to evaluate the effect of food on the PK of a single dose of 52.5 mg Hemay005 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy 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?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2018to 1 Mar 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy subjects aged 18 to 60 years, male and female volunteers;
- male Bodyweight（BW）≥ 50kg, female Bodyweight（BW）≥ 45kg, 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), 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);
- 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;
- Pregnancy or lactating females
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Randomized, Open-labeled, Single Dosing Study to Assess Food Effect on the Pharmacokinetics of Hemay005 in Healthy Volunteers
The purpose of this study is to evaluate the effect of food on the PK of a single dose of 52.5 mg Hemay005 in healthy subjects.
- Conditions
- Psoriasis
- Being tested
- Hemay005
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemay005Drug
Hemay005 tablets will be taken orally in dose of 52.5mg at fasted dosing on period one followed by fed dosing on period two.
Hemay005Drug
Hemay005 tablets will be taken orally in dose of 52.5mg at fed dosing on period one followed by fasted dosing on period two
| Study group | Role | What they receive |
|---|---|---|
| Hemay005 Fast | Experimental | Not described Receives: Drug: Hemay005 |
| Hemay005 Fed | Experimental | Not described Receives: Drug: Hemay005 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum observed plasma concentration
Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 ,72hours post-dose on day 1 and day 8
Tmax
Time of maximum concentration
Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 ,72hours post-dose on day 1 and day 8
AUCt
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 ,72hours post-dose on day 1 and day 8
AUC∞
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 ,72hours post-dose on day 1 and day 8
t1/2
Terminal elimination half-life
Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 ,72hours post-dose on day 1 and day 8
CL/F
Apparent total plasma clearance
Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 ,72hours post-dose on day 1 and day 8
Secondary outcomes (1)
Number of participants with adverse events, serious adverse events
Measured: Day 1 up to Day 11±3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start10 Oct 2018 (estimated)
- Primary completion10 Nov 2018 (estimated)
- Study completion1 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Hemay Bio-Tech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hongyun Wang, Doctor, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577626
- Sponsor's protocol ID
- HM005PS1S02
- Status last verified
- Jun 2018
- First submitted
- 22 Jun 2018
- Last updated
- 5 Jul 2018
- 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 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open-labeled, Single Dosing Study to Assess Food Effect on the Pharmacokinetics of Hemay005 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03577626
- Acronym / sponsor ID
- HM005PS1S02
- Conditions
- Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Tianjin Hemay Bio-Tech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2018 (estimated)
- Primary completion
- 10 Nov 2018 (estimated)
- Study completion
- 1 Mar 2019 (estimated)
- First posted
- 5 Jul 2018 (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.
The purpose of this study is to evaluate the effect of food on the PK of a single dose of 52.5 mg Hemay005 in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemay005 Fast | Experimental | Drug: Hemay005 |
| Hemay005 Fed | Experimental | Drug: Hemay005 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- healthy subjects aged 18 to 60 years, male and female volunteers;
- male Bodyweight（BW）≥ 50kg, female Bodyweight（BW）≥ 45kg, 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), 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);
- 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.
Key exclusion criteria (19 listed)
- 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;
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 |
|---|---|---|
| Hemay005Hemay005 tablets will be taken orally in dose of 52.5mg at fasted dosing on period one followed by fed dosing on period two. | Drug | Hemay005 Fast |
| Hemay005Hemay005 tablets will be taken orally in dose of 52.5mg at fed dosing on period one followed by fasted dosing on period two | Drug | Hemay005 Fed |
Primary outcome
Cmax
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 ,72hours post-dose on day 1 and day 8
Maximum observed plasma concentration
Tmax
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 ,72hours post-dose on day 1 and day 8
Time of maximum concentration
AUCt
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 ,72hours post-dose on day 1 and day 8
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration
AUC∞
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 ,72hours post-dose on day 1 and day 8
Area under the plasma concentration-time curve from time zero extrapolated to infinity
t1/2
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 ,72hours post-dose on day 1 and day 8
Terminal elimination half-life
CL/F
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 ,72hours post-dose on day 1 and day 8
Apparent total plasma clearance
1 secondary outcome
Number of participants with adverse events, serious adverse events
Time frame: Day 1 up to Day 11±3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
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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.
Hongyun Wang, Doctor principal investigator
Peking Union Medical College Hospital
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.
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 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: status not confirmed, as of the sponsor's last update on 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongyun Wang, Doctor (86-10-69156576, wanghy@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 ,72hours post-dose on day 1 and day 8). The study lists 6 primary outcomes in all. 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 5 Jul 2018.