Cancer Cachexia
Conditions
Brief summary
Oncocross is developing OC514, a drug-drug combination product containing 2 active pharmaceutical ingredients for cancer cachexia. This study is designed to assess the safety and tolerability of single and multiple oral doses of OC514 in healthy adult volunteers.
Detailed description
This is a single-center study in which a total of 24 subjects will be enrolled into 1 of 3 dose level cohorts in an ascending fashion. Each cohort will consist of 8 subjects randomized to receive OC514 or matching placebo at a ratio of 3:1. Eligible subjects will be admitted to the clinical research unit (CRU) from Day -1 to 5 and again from Day 15 to Day 17 and will be discharged upon completion of post-dose assessment. The subjects will attend the CRU for outpatients visits on Day 8 and Day 12. The subjects will return for a follow-up visit on Day 19 and End of Study visit on Day 21. The total study duration is up to 9 weeks consisting of up to 6 weeks of screening, 2 weeks of blinded treatment, and 1 week of safety follow-up. Safety oversight will be provided by a Safety Review Committee (SRC).
Interventions
DRUGOC514 (Low dose)
Low dose level of OC514
DRUGOC514 (Mid dose)
Mid dose level of OC514
DRUGOC514 (High dose)
High dose level of OC514
OTHERPlacebo
Placebo to match
Sponsors
Oncocross Australia Pty Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male or female volunteers, between 18 and 65 years of age, both inclusive. 2. BMI between 18 and 32 kg/m2 (inclusive) with a bodyweight \>/= 50 kg at screening. 3. Medically healthy with no clinically significant medical history. 4. Adequate venous access. 5. Non-pregnant, non-lactating females. 6. Must be able to comply with the requirements of the study.
Exclusion criteria
1. History of any clinically significant disease or disorder. 2. History or presence of gastrointestinal, hepatic, or renal disease or any other condition or past surgical intervention (eg, cholecystectomy). 3. Has creatinine clearance \< 60 mL/min. 4. Any current active infections, including localized infections, or any recent history (within 2 weeks prior to first IP administration) of active infections (including severe acute respiratory syndrome coronavirus 2 \[SARS-COV-2\]), cough or fever, or a history of recurrent or chronic infections. 5. Lymphoma, leukemia, or any malignancy within the past 5 years except for fully resected basal cell or squamous epithelial carcinomas of the skin that have been fully treated for at least 1 year with no recurrence. 6. Any positive laboratory-confirmed COVID-19 test at Screening or check-in. 7. History of human immunodeficiency virus (HIV) antibody positive or tested positive for HIV; had a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tested positive for HBsAg or anti-HCV at Screening. 8. Had major surgery (general anesthetic) in the last 3 months or minor surgery (local anesthetic) in the last 1 month prior to Screening. 9. History of narrow angle glaucoma. 10. History of benign prostatic hyperplasia (BPH) with lower urinary tract symptoms. 11. Any clinically significant medical or psychiatric condition, medical/surgical procedure, or trauma within 4 weeks prior to the first IP administration. 12. Blood donation within 1 month of Screening or any blood donation/blood loss greater than 500 mL during the 3 months prior to Screening. 13. Abnormal vital signs. 14. Prolonged Fridericia QT correction formula (QTcF) \> 450 msec or shortened QTcF \< 340 msec or family history of long QT syndrome at the Screening and on Day -1. 15. Positive screen for drugs of abuse or cotinine (≥ 500 ng/mL) or positive screen for alcohol at Screening or admission to the CRU on Day -1. 16. History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the Investigator, to any components in the IP.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of treatment-emergent adverse events (TEAEs) and treatment related TEAEs | Day 1- Day 21 | TEAEs will be measured as per the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 |
| Severity of TEAEs and treatment related TEAEs | Day 1- Day 21 | TEAEs will be measured as per the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 |
| Number of participants with abnormal clinically significant laboratory results | Day 1 - Day 21 | Clinical laboratory includes hematology, and biochemistry |
| Number of patients with abnormal vital signs | Day 1- Day 21 | Includes supine systolic and diastolic blood pressure, pulse rate, oxygen saturation, body temperature, and respiratory rate |
| Number of participants with abnormal and clinically significant electrocardiogram (ECG) | Day 1 - Day 21 | 12-lead ECG will be taken |
| Number of participants with abnormal urinalysis | Day 1- Day 21 | Dipstick test will be performed |
| Number of participants with abnormal coagulation test | Day 1- Day 21 | Prothrombin time, International normalization ratio, Activated partial thromboplastin time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| λz or Kel | Day 1-Day 4, Day 8, Day 16, Day 17 | Apparent terminal elimination rate |
| CL/F and CL/Fss | Day 1-Day 4, Day 8, Day 16, Day 17 | Apparent clearance |
| Cmax | Day 1-Day 4, Day 8, Day 16, Day 17 | Maximum concentration of OC514 in blood plasma |
| Effect of OC514 administration on QT prolongation | Day 4, Day 8, Day 12, Day 16, Day 17, day 19 | 12-lead ECG will be done |
| Vz/F and Vz/Fss | Day 1-Day 4, Day 8, Day 16, Day 17 | Volume of distribution |
| Tmax | Day 1-Day 4, Day 8, Day 16, Day 17 | Time to maximum concentration |
| Cmin | Day 1-Day 4, Day 8, Day 16, Day 17 | Minimum concentration |
| AUC (0-last) | Day 1-Day 4, Day 8, Day 16, Day 17 | Area under the time concentration curve from time zero to last measurable concentration |
| AUC (0-inf) | Day 1 and Day 2 | AUC from time zero to infinity |
| AUC (0-12) | Day 3-Day 16 | AUC from time zero until 12 hours post dose |
| t1/2 | Day 1-Day 4, Day 8, Day 16, Day 17 | Elimination half life |
Countries
Australia
Outcome results
None listed