Inflammatory Bowel DiseasePhase 1NCT02603185
PhaseⅠFirst-in-Human Study of Hemay007 in Healthy Volunteers
A Phase 1 study testing Hemay007 in people with Inflammatory Bowel Disease, run by Hemay Pharmaceutical PTY. LTD. at 1 site in Australia.
Trial summary
This phase I study designed in 3 parts is a randomized, placebo-controlled, sequential ascending-dose study of healthy volunteers. The safety, tolerability and pharmacokinetics of ascending single and multiple dose of Hemay007 will be assessed in Part 1 and Part 3, respectively. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- Hemay007
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteAustralia
- Study dates
- 9 Jan 2017to Mar 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female aged between 18 and 45 years (inclusive).
- Body weight >45 kg for females and > 50 kg for males, and Body Mass Index (BMI) between 19 and 30 kg/m2 inclusive.
- Female participants who return a negative pregnancy test (serum or urine) at both the screening visit and at Day -1.
- Female participants of childbearing potential with male partners must use a highly effective method of contraception/birth control (methods which result in low failure rate, i.e. less than 1% per year, when used consistently and correctly) and if currently lactating, participant's should not breast feed an infant while on this study, and for 3 months after the last dose of study drug has been taken.
- Examples of acceptable forms of highly effective contraception include:
- Established use of oral, injected or implanted hormonal methods of contraception.
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- Placement of an intrauterine device (IUD) or intrauterine system (IUS).
- Sterilised male partner (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate).
- True abstinence: When this is in line with the participant's preferred and usual lifestyle.
- Examples of non-acceptable methods of contraception include:
- Condoms alone or double barrier
- Periodic abstinence (e.g. calendar, ovulation, symptothermal, post ovulation)
- Withdrawal
- Spermicide (as it is not approved as a method of contraception in Australia) Male participants with female partners of child-bearing potential must agree to use a condom, in addition to their female partner using another acceptable method of contraception. Acceptable methods that may be used are listed in above from a) to e), or surgical sterilisation (vasectomy) from the screening visit until 6 months post-dose.
- For this study, a female is considered of non-childbearing potential if they are post-menopausal with ≥6 months' spontaneous amenorrhea or surgically sterile (e.g. bilateral tubal ligation, salpingectomy with or without oophorectomy, surgical hysterectomy, and bilateral oophorectomy).
- Males must agree to refrain from donating sperm, blood or plasma (other than for this study) while participating in this study and for at least 28 days after the last dose of study drug.
- Understands and is willing, able and likely to fully comply with study procedures and restrictions.
- Have voluntarily given written informed consent to participate in this study.
Who cannot join
- Medical Conditions
- A history of clinically severe gastrointestinal, hepatic, renal, cardiovascular, dermatological, immunological, respiratory, endocrine, oncological, neurological, metabolic, psychiatric disease or haematological disorders.
- A current or recent medical history of any clinically significant medical disease or surgery within 4 weeks of the screening visit.
- Have a gastrointestinal, hepatic or renal condition that may influence drug absorption or metabolism.
- Medications
- Current, within 14 days of the initial dose of study drug, or regular use of any prescription or over the counter (OTC) medication (while paracetamol is an exception) including herbal supplements.
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- Use of any drug that inhibits or induces hepatic metabolism of drugs within 30 days of planned study drug administration (e.g. inducers: barbiturates, carbamazepine, phenytoin, glucocorticoid and omeprazole; inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones and antihistamines).
- Known allergy to the study medication or any of its components.
- Recent history (within 6 months of the screening visit) 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, within 3 months of the screening visit, smoke more than 1 cigarettes or equivalent or who use other nicotine-containing products. Participants who are unable to abstain from smoking or using nicotine-containing products during the study.
- Participants who have donated, or plan to donate >450 mL of blood, or have donated plasma, within 12 weeks of the planned dosing date. All participants should be advised not to donate either blood or plasma for at least 6 weeks after completing the study.
- Clinically significant laboratory results at screening or prior to the first dose of study drug.These laboratory tests may be repeated once, if they are abnormal on first screening, and if there is a medical reason to believe the results may be inaccurate. If the repeat test is within the reference range, the participant may be included only if the investigator considers that the previous finding will not compromise the participant's safety and will not interfere with the interpretation of safety data. As to AST and ALT, hepatic function index of laboratory biochemical test≤1.5×ULN are allowed.
- Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, or hepatitis C virus antibody at screening.
- Clinically significant abnormal 12-lead ECG obtained at screening or prior to the first dose of study drug, as determined by the Principal Investigator or delegate.
- Clinically significant abnormal vital signs obtained at screening or prior to the first dose of study drug, as determined by the Principal Investigator or delegate.
- Use of any drug of abuse within 3 months of the screening visit, or unable to abstain from using drugs of abuse during the study period.
- A history of alcohol abuse or dependence within 12 months of the screening visit.
- Dietary habits or food intolerances which will interfere with the requirements for participants to consume a standardised diet whilst confined to the clinical unit.
- Participation in another clinical trial or receipt of an investigational drug within 3 months of the screening visit. Females who have had unprotected sex with a male partner within 30 days prior to the screening visit.
- Pregnancy or lactating females. Participants must be compliant with all inclusion and exclusion criteria unless, following discussions between the Investigator and the Sponsor, it is concluded that any minor deviation will not be of clinical significance and is considered unlikely to have any significant effect on the results of the study. The deviation and date of the decision will be documented in the CRF and the Study File.
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
CMAX Clinical Research Pty Ltd
Adelaide, South Australia, 5000
Dianne Pepper, PM, +61 8 7088 7900, dianne.pepper@cmax.com.au
Sepehr Shakib, Professor
About this study
Official title: A First-in-human, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Oral Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of Hemay007
This phase I study designed in 3 parts is a randomized, placebo-controlled, sequential ascending-dose study of healthy volunteers. The safety, tolerability and pharmacokinetics of ascending single and multiple dose of Hemay007 will be assessed in Part 1 and Part 3, respectively. Food effect following a single oral dose will be evaluated in Part 2.
- Conditions
- Inflammatory Bowel Disease
- Being tested
- Hemay007, placebo
- Keywords
- Phase 1, Healthy subjects
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemay007Drug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Hemay007 | Experimental | Part 1: Single ascending dose Group Hemay007 tablets will be taken orally once daily in doses of 0.2g, 0.6g,1.2g, 2g, 3g.
Part 2: Food effect group Hemay007 tablets will be taken orally in single dose with a high-fat, high-calorie meal or at overnight fasting.
Part 3: Multiple doses group Hemay007 tablets will be taken orally once daily in low, medium, high doses Receives: Drug: Hemay007 |
| Placebo | Placebo comparator | Part 1: Single ascending dose Group Placebo tablets will be taken orally once daily in doses of 0.2g, 0.6g,1.2g, 2g, 3g.
Part 3: Multiple doses group Placebo tablets will be taken orally once daily in low, medium, high doses Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events assessments after single and multiple ascending dose administration at baseline and repeatedly until study completion
This safety outcome combines the measure of the number of subjects experiencing adverse events (AEs), the nature and severity of those AEs and their relationship to the study treatments.
Measured: Starting about 24 hours before dosing and continued until about 7-14 days after last dose
Secondary outcomes (7)
Pharmacokinetics (PK) of Hemay007: time to reach the maximum concentration (Tmax) in Part 1 and Part 2
Measured: Day 1: pre-dose; 0.25h; 0,5h; 1h; 2h; 3h; 4h; 6h; 8h; 12h post dose, Day 2: 24h and 36h, Day 3: 48h and 60h, Day 4: 72h
PK of Hemay007: Observed maximum concentration (Cmax) in Part 1 and Part 2
Measured: Day 1: pre-dose; 0.25h; 0,5h; 1h; 2h; 3h; 4h; 6h; 8h; 12h post dose, Day 2: 24h and 36h, Day 3: 48h and 60h, Day 4: 72h
PK of Hemay007: Area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) in Part 1 and Part 2
Measured: Day 1: pre-dose; 0.25h; 0,5h; 1h; 2h; 3h; 4h; 6h; 8h; 12h post dose, Day 2: 24h and 36h, Day 3: 48h and 60h, Day 4: 72h
PK of Hemay007: time to reach the maximum concentration (Tmax) in Part 3
Measured: Day 1 and 21: pre-dose; 0.25h; 0,5h; 1h; 2h; 3h; 4h; 6h; 8h; 12h post dose, Day 2 and 22: 24h and 36h, Day 3 and 23: 48h and 60h, Day 4 and 24: 72h
PK of Hemay007: Observed maximum concentration (Cmax) in Part 3
Measured: Day 1 and 21: pre-dose; 0.25h; 0,5h; 1h; 2h; 3h; 4h; 6h; 8h; 12h post dose, Day 2 and 22: 24h and 36h, Day 3 and 23: 48h and 60h, Day 4 and 24: 72h
PK of Hemay007: Trough Plasma Concentrations in Part 3
Measured: Day 7 and 14 pre-dose
PK of Hemay007: Area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) after the first dose administration in Part 3
Measured: Day 1 and 21: pre-dose; 0.25h; 0,5h; 1h; 2h; 3h; 4h; 6h; 8h; 12h post dose, Day 2 and 22: 24h and 36h, Day 3 and 23: 48h and 60h, Day 4 and 24: 72h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study start9 Jan 2017
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hemay Pharmaceutical PTY. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tianjin Hemay Pharmaceutical Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02603185
- Sponsor's protocol ID
- Hemay007 AU01
- Status last verified
- Oct 2017
- First submitted
- 5 Nov 2015
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Oral Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of Hemay007
- ClinicalTrials.gov ID
- NCT02603185
- Acronym / sponsor ID
- Hemay007 AU01
- Conditions
- Inflammatory Bowel Disease
- Keywords
- Phase 1, Healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Hemay Pharmaceutical PTY. LTD.Industry (pharma, biotech, devices)
- Collaborators
- Tianjin Hemay Pharmaceutical Co., Ltd
- Study start
- 9 Jan 2017 (actual)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 11 Nov 2015 (estimated)
- 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.
This phase I study designed in 3 parts is a randomized, placebo-controlled, sequential ascending-dose study of healthy volunteers. The safety, tolerability and pharmacokinetics of ascending single and multiple dose of Hemay007 will be assessed in Part 1 and Part 3, respectively. Food effect following a single oral dose will be evaluated in Part 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemay007 | Experimental | Drug: Hemay007Part 1: Single ascending dose Group Hemay007 tablets will be taken orally once daily in doses of 0.2g, 0.6g,1.2g, 2g, 3g. Part 2: Food effect group Hemay007 tablets will be taken orally in single dose with a high-fat, high-calorie meal or at overnight fasting. Part 3: Multiple doses group Hemay007 tablets will be taken orally once daily in low, medium, high doses |
| Placebo | Placebo comparator | Drug: placeboPart 1: Single ascending dose Group Placebo tablets will be taken orally once daily in doses of 0.2g, 0.6g,1.2g, 2g, 3g. Part 3: Multiple doses group Placebo tablets will be taken orally once daily in low, medium, high doses |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Male or female aged between 18 and 45 years (inclusive).
- Body weight >45 kg for females and > 50 kg for males, and Body Mass Index (BMI) between 19 and 30 kg/m2 inclusive.
- Female participants who return a negative pregnancy test (serum or urine) at both the screening visit and at Day -1.
- Female participants of childbearing potential with male partners must use a highly effective method of contraception/birth control (methods which result in low failure rate, i.e. less than 1% per year, when used consistently and correctly) and if currently lactating, participant's should not breast feed an infant while on this study, and for 3 months after the last dose of study drug has been taken.
- For this study, a female is considered of non-childbearing potential if they are post-menopausal with ≥6 months' spontaneous amenorrhea or surgically sterile (e.g. bilateral tubal ligation, salpingectomy with or without oophorectomy, surgical hysterectomy, and bilateral oophorectomy).
Key exclusion criteria (20 listed)
- Medical Conditions
- Medications
- Known allergy to the study medication or any of its components.
- Recent history (within 6 months of the screening visit) 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, within 3 months of the screening visit, smoke more than 1 cigarettes or equivalent or who use other nicotine-containing products. Participants who are unable to abstain from smoking or using nicotine-containing products during the study.
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 |
|---|---|---|
| Hemay007 | Drug | Hemay007 |
| placebo | Drug | Placebo |
Primary outcome
Adverse events assessments after single and multiple ascending dose administration at baseline and repeatedly until study completion
Time frame: Starting about 24 hours before dosing and continued until about 7-14 days after last dose
This safety outcome combines the measure of the number of subjects experiencing adverse events (AEs), the nature and severity of those AEs and their relationship to the study treatments.
7 secondary outcomes
Pharmacokinetics (PK) of Hemay007: time to reach the maximum concentration (Tmax) in Part 1 and Part 2
Time frame: Day 1: pre-dose; 0.25h; 0,5h; 1h; 2h; 3h; 4h; 6h; 8h; 12h post dose, Day 2: 24h and 36h, Day 3: 48h and 60h, Day 4: 72h
PK of Hemay007: Observed maximum concentration (Cmax) in Part 1 and Part 2
Time frame: Day 1: pre-dose; 0.25h; 0,5h; 1h; 2h; 3h; 4h; 6h; 8h; 12h post dose, Day 2: 24h and 36h, Day 3: 48h and 60h, Day 4: 72h
PK of Hemay007: Area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) in Part 1 and Part 2
Time frame: Day 1: pre-dose; 0.25h; 0,5h; 1h; 2h; 3h; 4h; 6h; 8h; 12h post dose, Day 2: 24h and 36h, Day 3: 48h and 60h, Day 4: 72h
PK of Hemay007: time to reach the maximum concentration (Tmax) in Part 3
Time frame: Day 1 and 21: pre-dose; 0.25h; 0,5h; 1h; 2h; 3h; 4h; 6h; 8h; 12h post dose, Day 2 and 22: 24h and 36h, Day 3 and 23: 48h and 60h, Day 4 and 24: 72h
PK of Hemay007: Observed maximum concentration (Cmax) in Part 3
Time frame: Day 1 and 21: pre-dose; 0.25h; 0,5h; 1h; 2h; 3h; 4h; 6h; 8h; 12h post dose, Day 2 and 22: 24h and 36h, Day 3 and 23: 48h and 60h, Day 4 and 24: 72h
PK of Hemay007: Trough Plasma Concentrations in Part 3
Time frame: Day 7 and 14 pre-dose
PK of Hemay007: Area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) after the first dose administration in Part 3
Time frame: Day 1 and 21: pre-dose; 0.25h; 0,5h; 1h; 2h; 3h; 4h; 6h; 8h; 12h post dose, Day 2 and 22: 24h and 36h, Day 3 and 23: 48h and 60h, Day 4 and 24: 72h
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hemay007 in people with Inflammatory Bowel Disease, run by Hemay Pharmaceutical PTY. LTD. at 1 site in Australia.
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 18 inclusion and 20 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 24 Oct 2017. 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 Australia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yueying Zhen, PM (86 22 24929366, zhenyueying@hemay.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events assessments after single and multiple ascending dose administration at baseline and repeatedly until study completion (time frame: Starting about 24 hours before dosing and continued until about 7-14 days after last dose). 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 24 Oct 2017.