A Phase 1/Part A study of the pharmacokinetics and safety of three doses of Virofonol (polyphenol rich sugar cane extract).
- Conditions
- COVID-19Infection - Other infectious diseases
- Registration Number
- ACTRN12622000284763
- Lead Sponsor
- The Product Makers (TPM)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 18
1. Age 18 to 55 years (inclusive at screening), BMI 18.0 to 32.0 kg/m2 who have given written informed consent.
2. Non-smoker or light smokers” (less than or equal to 10 cigarettes or equivalent [e-cigarettes and marijuana] a week). Volunteers must agree to abstain from smoking whilst confine in the clinic
3. No clinically significant abnormalities (in the opinion of the Investigator) at the screening visit and prior to dosing.
4. Female volunteers of childbearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test at baseline.
5. Female volunteers must:
a. Be of nonchildbearing potential i.e., surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before screening) or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause, and a follicle stimulating hormone level > 40 IU/L at the screening visit), or
b. If women of childbearing potential (WOCBP), they must agree to be on hormonal contraception for at least 1 month prior to screening, not to donate ova, not to attempt to become pregnant and, if not exclusively in same-sex relationships, if engaging in sexual intercourse with a non-sterile male partner, must agree to use a highly effective method of contraception and the male partner wear a condom, from signing the consent form until at least 30 days after the dose of the study drug.
6. Male volunteers must:
a. Agree to use a condom when engaging in sexual intercourse with a WOCBP, a woman of nonchildbearing potential (WNOCBP), or a male partner. In addition, the participant’s female partner if a WOCBP, she must use one of the listed forms of highly effective methods of contraception from signing the consent form until at least 90 days after the dose of study drug.
b. Agree not to donate sperm from signing the consent form until at least 90 days after the dose of study drug.
Volunteers must have negative test result to Drugs of Abuse and Alcohol breath test at Screening and Admission (Day -1).
7. Have suitable venous access for blood sampling.
8. Be willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
9. Volunteers with non-invasive skin cancers (BCC or SCC) or who have had a fully resected BCC or SCC may participate at the discretion of the PI.
10. Volunteers must agree to restrict their intake of polyphenols for 2 days before admission (Day -1) and during study dosing and blood draws. The main food and drinks to restrict are citrus products particularly orange juice and tea and coffee.
1. Serious or unstable medical or psychiatric condition that would prevent the participant from providing informed consent with the exception of mild depression and anxiety
2. History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, GI, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or major surgery within the past 3 months determined by the PI to be clinically significant
3. Current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medications
4. Any history of malignant disease in the last 10 years (excludes surgically resected skin squamous cell or basal cell carcinoma)
5. Any surgical procedures requiring general anaesthesia within 1 month prior to screening or planned surgery during the study
6. For WOCBP, a positive serum pregnancy test at the screening visit or a positive urine pregnancy test (with confirmatory serum pregnancy test) at Admission (Day -1).
7. Females who are breastfeeding or planning to breast feed at any time during the study
8. Positive test results of active human immunodeficiency virus (HIV) or hepatitis B surface antigen (HBsAg) antibodies at the screening visit. If subjects are HCV antibody positive, but PCR negative, they may be enrolled as this is assumed to be a cure of HCV.
9. History of substance abuse or alcohol abuse (defined as more than 13 to 14 standard drinks per week or regularly consuming more than 4 standard drinks on any one day; where 1 standard drink is 10 g of pure alcohol and is equivalent to 285 mL beer [4.9% Alc./Vol], 100 mL wine [12% Alc./Vol], 30 mL spirit [40% Alc./Vol]) within 12 weeks prior to the screening visit.
10. Use of any prescription or over-the-counter medication (including herbal products, diet aids, and hormone supplements) within 10 days prior to the first study drug administration. Exceptions include: use of contraceptives; occasional use of paracetamol (doses of 500 mg up to every 6 hours or 2 g per day maximum for no more than 3 consecutive days); ibuprofen (doses of 400 mg up to every 6 hours or 1.6 g per day maximum for no more than 3 consecutive days); topical ointments, vitamins or dietary supplements, and any medication that, in the opinion of the Sponsor and the PI, would not be anticipated to impact the objectives of the study.
11. Use of any vaccinations within 14 days prior to the first study drug administration. Exception include: COVID-19 vaccination or booster is allowed up to 7 days prior to study drug administration.
12. Treatment with an investigational drug in another clinical trial within 30 days or 5 half-lives (whichever is longer) prior to the first administration of study drug in this trial
13. Any other condition or prior therapy that in the opinion of the Investigator would make the volunteer unsuitable for this study, including an inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method