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

NCT05264038 | Completed Phase 1 DMC

• 1 other identifier: OC514-001
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Cachexia

Outcome Measures

Primary Outcomes (7)

• Number of treatment-emergent adverse events (TEAEs) and treatment related TEAEs

  TEAEs will be measured as per the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0

  Day 1- Day 21

• Severity of TEAEs and treatment related TEAEs

  TEAEs will be measured as per the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0

  Day 1- Day 21

• Number of participants with abnormal clinically significant laboratory results

  Clinical laboratory includes hematology, and biochemistry

  Day 1 - Day 21

• Number of patients with abnormal vital signs

  Includes supine systolic and diastolic blood pressure, pulse rate, oxygen saturation, body temperature, and respiratory rate

  Day 1- Day 21

• Number of participants with abnormal and clinically significant electrocardiogram (ECG)

  12-lead ECG will be taken

  Day 1 - Day 21

• Number of participants with abnormal urinalysis

  Dipstick test will be performed

  Day 1- Day 21

• Number of participants with abnormal coagulation test

  Prothrombin time, International normalization ratio, Activated partial thromboplastin time

  Day 1- Day 21

Secondary Outcomes (11)

• Cmax

  Day 1-Day 4, Day 8, Day 16, Day 17

• Tmax

  Day 1-Day 4, Day 8, Day 16, Day 17

• Cmin

  Day 1-Day 4, Day 8, Day 16, Day 17

• AUC (0-last)

  Day 1-Day 4, Day 8, Day 16, Day 17

• AUC (0-inf)

  Day 1 and Day 2

Study Arms (3)

Cohort 1

EXPERIMENTAL

Participants will receive either low dose level of OC514 or placebo

Drug: OC514 (Low dose); Other: Placebo

Cohort 2

EXPERIMENTAL

Participants will receive either mid dose level of OC514 or placebo

Drug: OC514 (Mid dose); Other: Placebo

Cohort 3

EXPERIMENTAL

Participants will receive either high dose level of OC514 or placebo

Drug: OC514 (High dose); Other: Placebo

Interventions

OC514 (Low dose) DRUG

Low dose level of OC514

Also known as: OC514

Cohort 1

OC514 (Mid dose) DRUG

Mid dose level of OC514

Also known as: OC514

Cohort 2

OC514 (High dose) DRUG

High dose level of OC514

Also known as: OC514

Cohort 3

Placebo OTHER

Placebo to match

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oncocross Australia Pty Ltd.: lead

Study Sites (1)

Nucleus network

Melbourne, Australia

Location

Study Officials

• Ofer Gonen, Dr.

  Nucleus Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: March 3, 2022
• Study Start: March 3, 2022
• Primary Completion: September 7, 2022
• Study Completion: March 13, 2023
• Last Updated: March 20, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)