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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04676711




Registration number
NCT04676711
Ethics application status
Date submitted
15/12/2020
Date registered
21/12/2020

Titles & IDs
Public title
A Study of GFH312 in Healthy Subjects
Scientific title
A First-in-human, Randomized, Double-blinded, Placebo- Controlled, Two-part Study to Assess Safety/Tolerability and Pharmacokinetics of Single- and Multiple-ascending Doses and Food Effect of GFH312 in Healthy Subjects
Secondary ID [1] 0 0
GFH312X3101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Toxicity 0 0
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GFH312
Treatment: Drugs - Placebo

Experimental: GFH312 -

Placebo comparator: Placebo -


Treatment: Drugs: GFH312
Subjects are planned to be dosed in oral tablet, with single and multiple ascending doses

Treatment: Drugs: Placebo
Subjects are planned to be dosed in oral tablet, with single and multiple ascending doses
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety /Tolerability of GFH312 (adverse events)
Timepoint [1] 0 0
approximately 45 days

Eligibility
Key inclusion criteria
Inclusion Criteria

1. Written informed consent must be obtained before any assessment is performed.
2. Healthy male and female subjects age 18 to 55 years of age included.
3. Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18-32 kg/m2 inclusive.
4. At screening, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the sitting position after the subject has rested for at least three minutes, and again (when required) after three minutes in the standing position. Sitting vital signs should be within the normal ranges.
5. Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant must use highly effective methods of contraception during intercourse while taking drug and for 30 days after stopping study medication; and sexually active males must use a condom, during intercourse while taking drug and for 30 days after stopping study medication.
6. Able to communicate well with the investigator, to understand and comply with the requirements of the study.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria

Healthy subjects fulfilling any of the following criteria are not eligible for inclusion in this study:

1. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.
2. Hemoglobin levels below the lower limit of normal (LLN) as set by the laboratory.
3. An elevated C-reactive protein (CRP) outside of the normal reference range and has clinical significance, or above 10 mg/L.
4. A positive anti-nuclear antibody (ANA) above 1:160 titer.
5. A positive Tuberculosis test.
6. A history of clinically significant ECG abnormalities, or any abnormalities defined in protocol.
7. History of immunodeficiency diseases, including a positive test for HIV antibody.
8. Chronic infection with Hepatitis B (HBV) or Hepatitis C (HCV).
9. Infections requiring parenteral antibiotics within the 6 months prior to Screening.
10. History of any venous thromboembolism, TIA, intracranial hemorrhage, neoplasm, arteriovenous malformation, vasculitis, bleeding disorder, coagulation disorders or screening blood tests that indicate altered coagulability (platelet count, APTT, PT, etc.).
11. History of significant cardiovascular, respiratory, renal, neurological disease.
12. Significant illness which has not resolved within two (2) weeks prior to initial dosing.
13. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
14. Recent (within the last three years) and/or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc.).
15. Known family history or known presence of long QT syndrome, or concomitant use of agents known to prolong the QT interval unless they can be permanently discontinued for the duration of study.
16. History of hypersensitivity to any of the study treatments or excipients (e.g., lactose monohydrate) or to drugs of similar chemical classes; and history of anaphylaxis or other significant allergy in the opinion of the Investigator.
17. Donation or loss of 400 ml or more of blood within eight (8) weeks prior to initial dosing, or longer if required by local regulation.
18. Plasma donation (>400 mL) within 14 days prior to first dosing.
19. Use of any prescription drugs, herbal supplements (including Silybum marianum and Valeriana officinalis), within two weeks prior to initial dosing, and/or over-the- counter (OTC) medication, dietary supplements (vitamins included) within one weeks prior to initial dosing.
20. Smokers of more than two per week. Urine cotinine levels will be measured during screening, and urine cotinine = 500 ng/ml will exclude a subject.
21. History of drug abuse or unhealthy alcohol use within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during screening.
22. History of recreational cannabis use within four weeks prior to dosing, or evidence of such use as indicated by the laboratory assays conducted during screening.
23. Participant is unwilling to refrain from strenuous exercise (including weightlifting) from 7 days prior to admission to the site until completion of the final Follow-up visit.
24. With a plan to receive vaccination with a live vaccine within 4 weeks prior to the first dosing or within 4 weeks of the last dosing; With a plan to receive COVID-19 vaccination within 2 weeks prior to the first dosing or within 1 week of the last dosing.
25. Exposure to any significantly immune suppressing drug (including experimental therapies as part of a clinical trial) within the 4 months prior to screening or 5 half-lives, whichever is longer.
26. Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days, or twice the duration of the biological effect of the investigational product, whichever is longer; or longer if required by local regulations.
27. Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
28. (Part ? only) Score 'yes' on item 4 or item 5 of the Suicidal Ideation section of the C-SSRS, if this ideation occurred in the past 6 months, or 'yes' on any item of the Suicidal Behavior section, except for the 'Non-Suicidal Self-Injurious Behavior' (item also included in the Suicidal Behavior section), if this behavior occurred in the past 2 years. Or history of drug abuse or mental disease.

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 administering 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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/10/2022
Sample size
Target
Accrual to date
Final
76
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Pty Ltd - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GenFleet Therapeutics (Australia) Pty Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04676711