Overview
A First in Human Study of the Safety, Tolerability and Pharmacokinetics of PRV-002 in Healthy Volunteers
Status:
Recruiting
Recruiting
Trial end date:
2021-11-30
2021-11-30
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of different dose levels of PRV-002 in Health VolunteersPhase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Odyssey Group International, Inc.Collaborator:
Avance Clinical Pty Ltd.
Criteria
Inclusion Criteria:1. Must have given written informed consent before any study-related activities are
carried out and must be able to understand the full nature and purpose of the trial,
including possible risks and adverse effects.
2. Adult males and females, 18 to 55 years of age (inclusive) at screening.
3. Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2, with a body weight (to 1 decimal place)
≥ 50 kg at screening.
4. Be non-smokers (including tobacco, e-cigarettes and marijuana) for at least 3 months
prior to first study drug administration.
5. Have a negative test for cotinine at the screening visit and at check-in on Day -1.
6. Medically healthy without clinically significant abnormalities (in the opinion of the
Investigator) at the screening visit in the Schedules of
Assessments (SoA), including:
1. Physical examination without any clinically significant findings
2. Systolic BP in the range of 90 to 160 mmHg (inclusive) and diastolic BP in the
range of 50 to 95 mmHg (inclusive) after 5 minutes in supine position
3. Heart rate in the range of 40 to 100 bpm (inclusive) after 5 minutes rest in
supine position
4. Body temperature (tympanic or oral) in the range 35.5°C to 37.7°C (inclusive)
5. No clinically significant findings in serum chemistry, haematology, coagulation,
and urinalysis tests
6. Triplicate 12-lead ECG (taken after the volunteer has been supine for at least 5
minutes) with a QTcF ≤ 450 msec for males and ≤ 470 msec for females and no
clinically significant abnormalities
7. Pulmonary assessments must be within the normal range (forced expiratory volume
in 1 second [FEV1], forced vital capacity [FVC] and FEV1/FVC ratio ≥ 80% of
normal values; f forced expiratory flow over the middle one half of the FVC
[FEF25-75%] > 75% of predicted)
8. Oxygen saturation (SpO2) monitor ≥ 95%.
7. Medically healthy without clinically significant abnormalities (in the opinion of the
Investigator) at the timepoints indicated in the Schedules of Assessments (SoA),
including:
1. Physical examination without any clinically significant findings
2. Systolic BP in the range of 90 to 160 mmHg (inclusive) and diastolic BP in the
range of 50 to 95 mmHg (inclusive) after 5 minutes in supine position
3. Heart rate in the range of 40 to 100 bpm (inclusive) after 5 minutes rest in
supine position
4. Body temperature (tympanic or oral) in the range 35.5°C to 37.7°C (inclusive)
5. No clinically significant findings in serum chemistry, haematology, coagulation,
and urinalysis tests
6. Triplicate 12-lead ECG (taken after the volunteer has been supine for at least 5
minutes) with a QTcF ≤ 450 msec for males and ≤ 470 msec for females and no
clinically significant abnormalities
7. Pulmonary assessments must be within the normal range (forced expiratory volume
in 1 second [FEV1], forced vital capacity [FVC] and FEV1/FVC ratio ≥ 80% of
normal values; f forced expiratory flow over the middle one half of the FVC
[FEF25-75%] > 75% of predicted)
8. Oxygen saturation (SpO2) monitor ≥ 95%.
8. Female volunteers must:
1. 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
2. Have a follicle-stimulating hormone level >40 IU/L at the screening visit),or
3. If of childbearing potential, must agree not to donate ova, not to attempt to
become pregnant and, if engaging in sexual intercourse with a male partner, must
agree to use an acceptable method of contraception from signing the consent form
until at least 30 days after the last dose of the study drug.
9. Male volunteers must agree not to donate sperm and, if engaging in sexual intercourse
with a female partner who could become pregnant, must agree to use an acceptable
method of contraception from signing the consent form until at least 90 days after the
last dose of study drug.
10. Have suitable venous access for blood sampling.
11. Be willing and able to comply with all study assessments and adhere to the protocol
schedule and restrictions.
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Exclusion Criteria:
1. History or presence of significant cardiovascular disease
2. History or presence of significant pulmonary disease
3. History or presence of significant hepatic disease
4. History or presence of significant renal disease
5. History or presence of significant haematological disease
6. History or presence of significant gastrointestinal disease
7. History or presence of significant disease
8. History or presence of significant endocrine disease
9. History or presence of significant immunologic disease
10. History or presence of significant dermatologic disease
11. History or presence of significant or neurological disease
12. No major surgery within the past 3 months determined by the PI to be clinically
significant.
13. Absence of any acute illness.
14. Current infection that requires systemically absorbed antibiotic.
15. Current infection that requires systemically absorbed antifungal.
16. Current infection that requires systemically absorbed antiparasitic.
17. Current infection that requires systemically absorbed antiviral medication.
18. Any history of malignant disease in the last 10 years (excludes surgically resected
skin squamous cell or basal cell carcinoma).
19. Presence of clinically relevant immunosuppression from, but not limited to,
immunodeficiency conditions such as common variable hypogammaglobulinemia.
20. Use of or plans to use systemic immunosuppressive (e.g., corticosteroids,
methotrexate, azathioprine, cyclosporine) or immunomodulating medications (e.g.,
interferon) during the study or within 3 months prior to the first study drug
administration.
21. History of risk factors for torsade de pointes (including a family history of long QT
syndrome or sudden cardiac death).
22. Known arrythmia
23. Liver function test results elevated more than 1.5-fold above the ULN for gamma
glutamyl transferase, bilirubin (total, conjugated and unconjugated), ALP, AST or ALT.
Volunteers with ALP and/or ALT/AST above the limits specified may be included, at the
discretion of the Investigator, if the levels are unaccompanied by clinical signs and
are determined to be normal variants.
24. Liver function test results elevated more than 1.5-fold above the ULN for gamma
glutamyl transferase
25. Liver function test results elevated more than 1.5-fold above the ULN for bilirubin
(total)
26. Liver function test results elevated more than 1.5-fold above the ULN for bilirubin
(conjugated)
27. Liver function test results elevated more than 1.5-fold above the ULN for ALP.
Volunteers with ALP above the limits specified may be included, at the discretion of
the Investigator, if the levels are unaccompanied by clinical signs and are determined
to be normal variants.
28. Liver function test results elevated more than 1.5-fold above the ULN for AST.
Volunteers with AST above the limits specified may be included, at the discretion of
the Investigator, if the levels are unaccompanied by clinical signs and are determined
to be normal variants.
29. Liver function test results elevated more than 1.5-fold above the ULN for ALT.
Volunteers with ALT above the limits specified may be included, at the discretion of
the Investigator, if the levels are unaccompanied by clinical signs and are determined
to be normal variants.
30. Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2)
antibodies at the screening visit.
31. Positive test results for active hepatitis B surface antigen (HBsAg) antibodies at the
screening visit.
32. Positive test results for active hepatitis C virus (HCV) antibodies at the screening
visit.
33. Presence or having sequelae of known to interfere with the absorption, distribution,
metabolism, or excretion of drugs such as gastrointestinal, liver, kidney, or other
conditions .
34. Estimated creatinine clearance < 60 mL/min using the Cockcroft-Gault formula or serum
creatinine more than 1.5-fold above the ULN.
35. History of substance abuse or alcohol abuse (defined as more than 10 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.
36. Positive drugs of abuse at the screening visit.
37. Positive drugs of abuse at check-in (Day -1).
38. Positive alcohol breath test results at the screening visit.
39. Positive alcohol breath test results at check-in (Day -1).
40. 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, and vitamins or
dietary supplements.
41. Consumption of grapefruit or Seville orange (or products containing grapefruit or
Seville orange) within 10 days prior to the first administration of study drug.
42. Demonstrated clinically significant (required intervention, e.g., emergency room
visit, epinephrine administration) allergic reactions (e.g., food, drug, or atopic
reactions, asthmatic episodes) which, in the opinion of the Investigator, would
interfere with the volunteer's ability to participate in the trial.
43. Known hypersensitivity to any of the study drug ingredients.
44. Use of any vaccinations within 14 days prior to the first study drug administration.
45. For women of childbearing potential, a positive serum pregnancy test at the screening
visit.
46. For women of childbearing potential, a positive urine pregnancy test (with
confirmatory serum pregnancy test) at check-in (Day -1).
47. Females who are breastfeeding or planning to breast feed at any time during the study.
48. Donation of blood or plasma within 30 days prior to first study drug administration.
49. Loss of whole blood of more than 500 mL within 30 days prior to first study drug
administration.
50. Receipt of a blood transfusion within 1 year of first study drug administration.
51. Participation in another clinical trial of an investigational drug within 60 days of
the first study drug administration.
52. Any other condition or prior therapy that in the opinion of the Investigator would
make the volunteer unsuitable for this study, including inability to cooperate fully
with the requirements of the study protocol or likelihood of noncompliance with any
study requirements.
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