Status:
COMPLETED
A First in Human Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics Effects of OC514
Lead Sponsor:
Oncocross Australia Pty Ltd.
Conditions:
Cancer Cachexia
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 singl...
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 OC51...
Eligibility Criteria
Inclusion
- Healthy male or female volunteers, between 18 and 65 years of age, both inclusive.
- BMI between 18 and 32 kg/m2 (inclusive) with a bodyweight \>/= 50 kg at screening.
- Medically healthy with no clinically significant medical history.
- Adequate venous access.
- Non-pregnant, non-lactating females.
- Must be able to comply with the requirements of the study.
Exclusion
- History of any clinically significant disease or disorder.
- History or presence of gastrointestinal, hepatic, or renal disease or any other condition or past surgical intervention (eg, cholecystectomy).
- Has creatinine clearance \< 60 mL/min.
- 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.
- 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.
- Any positive laboratory-confirmed COVID-19 test at Screening or check-in.
- 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.
- Had major surgery (general anesthetic) in the last 3 months or minor surgery (local anesthetic) in the last 1 month prior to Screening.
- History of narrow angle glaucoma.
- History of benign prostatic hyperplasia (BPH) with lower urinary tract symptoms.
- Any clinically significant medical or psychiatric condition, medical/surgical procedure, or trauma within 4 weeks prior to the first IP administration.
- Blood donation within 1 month of Screening or any blood donation/blood loss greater than 500 mL during the 3 months prior to Screening.
- Abnormal vital signs.
- 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.
- 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.
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the Investigator, to any components in the IP.
Key Trial Info
Start Date :
March 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2023
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT05264038
Start Date
March 3 2022
End Date
March 13 2023
Last Update
March 20 2023
Active Locations (1)
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1
Nucleus network
Melbourne, Australia