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

A Phase 1, Randomized, Double-Blind, Dose-Ranging, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics Effects of OC514 in Healthy Adult Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Cancer Cachexia
• Intervention / Treatment: Other: Placebo; Drug: OC514 (Low dose); Drug: OC514 (Mid dose); Drug: OC514 (High dose)

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).

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Melbourne, Australia
    • Nucleus Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; Participants will receive either low dose level of OC514 or placebo	Other: Placebo; Placebo to match; Drug: OC514 (Low dose); Low dose level of OC514; Other Names: OC514
Experimental: Cohort 2; Participants will receive either mid dose level of OC514 or placebo	Other: Placebo; Placebo to match; Drug: OC514 (Mid dose); Mid dose level of OC514; Other Names: OC514
Experimental: Cohort 3; Participants will receive either high dose level of OC514 or placebo	Other: Placebo; Placebo to match; Drug: OC514 (High dose); High dose level of OC514; Other Names: OC514

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum concentration of OC514 in blood plasma	Day 1-Day 4, Day 8, Day 16, Day 17
Tmax	Time to maximum concentration	Day 1-Day 4, Day 8, Day 16, Day 17
Cmin	Minimum concentration	Day 1-Day 4, Day 8, Day 16, Day 17
AUC (0-last)	Area under the time concentration curve from time zero to last measurable concentration	Day 1-Day 4, Day 8, Day 16, Day 17
AUC (0-inf)	AUC from time zero to infinity	Day 1 and Day 2
AUC (0-12)	AUC from time zero until 12 hours post dose	Day 3-Day 16
t1/2	Elimination half life	Day 1-Day 4, Day 8, Day 16, Day 17
λz or Kel	Apparent terminal elimination rate	Day 1-Day 4, Day 8, Day 16, Day 17
CL/F and CL/Fss	Apparent clearance	Day 1-Day 4, Day 8, Day 16, Day 17
Vz/F and Vz/Fss	Volume of distribution	Day 1-Day 4, Day 8, Day 16, Day 17
Effect of OC514 administration on QT prolongation	12-lead ECG will be done	Day 4, Day 8, Day 12, Day 16, Day 17, day 19

Collaborators and Investigators

• Sponsor: Oncocross Australia Pty Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2022
• Primary Completion (Actual): September 7, 2022
• Study Completion (Actual): March 13, 2023

Study Registration Dates

• First Submitted: January 28, 2022
• First Submitted That Met QC Criteria: February 21, 2022
• First Posted (Actual): March 3, 2022

Study Record Updates

• Last Update Posted (Actual): March 20, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Emaciation; Weight Loss; Cachexia
• Other Study ID Numbers: OC514-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No