A First in Human Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics Effects of OC514

NCT ID: NCT05264038

Last Updated: 2023-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-03
• Study Completion Date: 2023-03-13

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).

Conditions

Cancer Cachexia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cohort 1

Participants will receive either low dose level of OC514 or placebo

Group Type: EXPERIMENTAL

OC514 (Low dose)

Intervention Type: DRUG

Low dose level of OC514

Placebo

Intervention Type: OTHER

Placebo to match

Cohort 2

Participants will receive either mid dose level of OC514 or placebo

Group Type: EXPERIMENTAL

OC514 (Mid dose)

Intervention Type: DRUG

Mid dose level of OC514

Placebo

Intervention Type: OTHER

Placebo to match

Cohort 3

Participants will receive either high dose level of OC514 or placebo

Group Type: EXPERIMENTAL

OC514 (High dose)

Intervention Type: DRUG

High dose level of OC514

Placebo

Intervention Type: OTHER

Placebo to match

Interventions

OC514 (Low dose)

Low dose level of OC514

Intervention Type: DRUG

OC514 (Mid dose)

Mid dose level of OC514

Intervention Type: DRUG

OC514 (High dose)

High dose level of OC514

Intervention Type: DRUG

Placebo

Placebo to match

Intervention Type: OTHER

Other Intervention Names

OC514; OC514; OC514

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oncocross Australia Pty Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ofer Gonen, Dr.

Role: PRINCIPAL_INVESTIGATOR

Nucleus Network

Locations

Nucleus network

Melbourne, , Australia

Countries

Australia

Other Identifiers

OC514-001

Identifier Type: -

Identifier Source: org_study_id