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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02603185




Registration number
NCT02603185
Ethics application status
Date submitted
5/11/2015
Date registered
11/11/2015
Date last updated
24/10/2017

Titles & IDs
Public title
Phase?First-in-Human Study of Hemay007 in Healthy Volunteers
Scientific 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
Secondary ID [1] 0 0
Hemay007 AU01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory Bowel Disease 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Hemay007
Treatment: Drugs - placebo

Experimental: Hemay007 - 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

Placebo Comparator: Placebo - 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


Treatment: Drugs: Hemay007


Treatment: Drugs: placebo


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Starting about 24 hours before dosing and continued until about 7-14 days after last dose
Secondary outcome [1] 0 0
Pharmacokinetics (PK) of Hemay007: time to reach the maximum concentration (Tmax) in Part 1 and Part 2
Timepoint [1] 0 0
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
Secondary outcome [2] 0 0
PK of Hemay007: Observed maximum concentration (Cmax) in Part 1 and Part 2
Timepoint [2] 0 0
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
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
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
Secondary outcome [4] 0 0
PK of Hemay007: time to reach the maximum concentration (Tmax) in Part 3
Timepoint [4] 0 0
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
Secondary outcome [5] 0 0
PK of Hemay007: Observed maximum concentration (Cmax) in Part 3
Timepoint [5] 0 0
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
Secondary outcome [6] 0 0
PK of Hemay007: Trough Plasma Concentrations in Part 3
Timepoint [6] 0 0
Day 7 and 14 pre-dose
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
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

Eligibility
Key inclusion criteria
1. Male or female aged between 18 and 45 years (inclusive).

2. Body weight >45 kg for females and > 50 kg for males, and Body Mass Index (BMI)
between 19 and 30 kg/m2 inclusive.

3. Female participants who return a negative pregnancy test (serum or urine) at both the
screening visit and at Day -1.

4. 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.

- 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).

5. 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.

6. Understands and is willing, able and likely to fully comply with study procedures and
restrictions.

7. Have voluntarily given written informed consent to participate in this study.
Minimum age
18 Years
Maximum age
45 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Medical Conditions

1. A history of clinically severe gastrointestinal, hepatic, renal, cardiovascular,
dermatological, immunological, respiratory, endocrine, oncological, neurological,
metabolic, psychiatric disease or haematological disorders.

2. A current or recent medical history of any clinically significant medical disease
or surgery within 4 weeks of the screening visit.

3. Have a gastrointestinal, hepatic or renal condition that may influence drug
absorption or metabolism.

2. Medications

1. 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.

2. 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).

3. Known allergy to the study medication or any of its components.

4. 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).

5. 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.

6. 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.

7. 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.

8. Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B
virus surface antigen, or hepatitis C virus antibody at screening.

9. 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.

10. 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.

11. 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.

12. A history of alcohol abuse or dependence within 12 months of the screening visit.

13. Dietary habits or food intolerances which will interfere with the requirements for
participants to consume a standardised diet whilst confined to the clinical unit.

14. 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.

15. 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hemay Pharmaceutical PTY. LTD.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Tianjin Hemay Pharmaceutical Co.,Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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. Food effect following a single oral dose will be evaluated in Part 2.
Trial website
https://clinicaltrials.gov/show/NCT02603185
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Yueying Zhen, PM
Address 0 0
Country 0 0
Phone 0 0
86 22 24929366
Fax 0 0
Email 0 0
zhenyueying@hemay.com.cn
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02603185