A Phase 1 Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of the AUM001 in Healthy Volunteers
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Multiple Ascending Doses Of AUM001 In Normal Healthy Volunteers
AUM Biosciences Pty Ltd
24 participants
Nov 27, 2019
Interventional
Conditions
Summary
This Is a First In Human Phase 1 Single Center, Randomized Double-Blind, Placebo-Controlled Study To Evaluate The Safety Tolerability And Pharmacokinetics of MultipleE Ascending Doses of AUM001 In Normal Healthy Volunteers This study will evaluate the safety, tolerability and pharmacokinetics of multiple ascending doses of AUM001 in healthy volunteers. You may be eligible to join this study if you are aged 18 and above and below 50, are healthy with no active or chronic diseases/disorders Participants in this study are randomly allocated (by chance) to one of two groups in one of three cohorts in ascending doses Safety, tolerability and pharmacokinetics will be assessed at regular intervals using clinical examinations and blood tests. This study is not open to cancer patients, and should not be promoted as such. Recruitment will be restricted to those volunteers identified as fitting the selection criteria by the Phase I Clinical trial Unit. his is a healthy volunteer study. It is proposed that the drug will be evaluated for the treatment of patients with a range of solid and liquid tumours"
Eligibility
Inclusion Criteria10
- Male or female, light smokers, greater than or equal to 18 and less than or equal to 50 years of age, with BMI greater than 18.5 and less than 30.0 kg/m2 and body weight greater than or equal to 50.0 kg for males and less than or equal to 45.0 kg for females.
- Female subjects must be non-pregnant, non-lactating, postmenopausal for at least 1 year, surgically sterile, or agree to use an acceptable form of contraception from the time of signing informed consent until 30 days after Study Completion. Females of childbearing potential who are sexually active with a non-sterile male partner (sterile male partners are defined as men vasectomized since at least 6 months) must be willing to use one of the following acceptable contraceptive:
- Male subjects who are not vasectomized for at least 6 months, and who are sexually active with a female partner of childbearing potential must be willing to use one of the following acceptable contraceptive methods from the first study drug administration until at least 90 days after the last study drug administration:
- Male subjects with a pregnant partner must agree to use a condom from the first study drug administration until at least 90 days after the last study drug administration.
- Male subjects must be willing not to donate sperm until 90 days following the last study drug administration.
- Subjects will be required to read, understand, and sign the informed consent and will be able to spend the days specified in the study schedule confined in a facility under study rules.
- Subjects will have no history of cardiac disease.
- Each subject’s baseline Safety Laboratory Assessment values must have no clinically significant abnormalities. This includes hematology, clinical chemistry, and urine analysis.
- Subjects must be healthy volunteers with no active or chronic diseases/disorders,
- Subjects will not have any allergy to the test article or to the constituents of the capsules
Exclusion Criteria12
- Women who are nursing or pregnant.
- Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test article.
- Acute disease state
- Admitted alcohol abuse or consumption of more than 2 standard units per day in the last 6 months.
- Any clinically important deviation from normal limits in physical examination, vital signs, or clinical laboratory test results.
- Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or HCV antibodies.
- Positive urine drug screen or alcohol test
- History of allergy to any component of the test article.
- Use of any prescription drug within 30 days prior to first dosing.
- Use of any over-the-counter drugs including herbal supplements and Traditional Chinese Medicines within 14 days prior to first dosing.
- Diets that alter metabolism
- Participation in another clinical trial within 3 months prior to first dosing.
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Interventions
AUM001 capsules will be administered in total 3 Cohorts with multiple ascending doses. Subjects will receive active study drug AUM001 and matching placebo every other day over 13 days Cohort 1: 5 mg (administered as 1 X 5 mg capsule) Cohort 2: 10 mg (administered as 1 x 10 mg capsule) Cohort 3: 20 mg (administered as 2 x 10 mg capsule) IP will be administered via appropriate trained site staff in presence of medical personnel. Each time an IMP is dispensed to a participant, received from the supplier and / or returned or destroyed, the occurrence will be documented on the accountability log for the purpose of adherence. Subsequent Cohort starts only after the preceding cohort finishes. Each participant will only be enrolled in one cohort.
Locations(1)
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ACTRN12620000572965