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

Cancer Cachexia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05264038
• Other study ID #: OC514-001
• Status: Completed
• Phase: Phase 1
• Start date: March 3, 2022
• Est. completion date: March 13, 2023

Study information

• Verified date: March 2023
• Source: Oncocross Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 13, 2023
• Est. primary completion date: September 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cachexia
• Cancer Cachexia

Intervention

Drug:
• OC514 (Low dose)
Low dose level of OC514
• OC514 (Mid dose)
Mid dose level of OC514
• OC514 (High dose)
High dose level of OC514

Other:
• Placebo
Placebo to match

Locations

Country	Name	City	State
Australia	Nucleus network	Melbourne

Sponsors (1)

Lead Sponsor	Collaborator
Oncocross Australia Pty Ltd.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Number of participants with abnormal clinically significant laboratory results	Clinical laboratory includes hematology, and biochemistry	Day 1 - Day 21
Primary	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
Primary	Number of participants with abnormal and clinically significant electrocardiogram (ECG)	12-lead ECG will be taken	Day 1 - Day 21
Primary	Number of participants with abnormal urinalysis	Dipstick test will be performed	Day 1- Day 21
Primary	Number of participants with abnormal coagulation test	Prothrombin time, International normalization ratio, Activated partial thromboplastin time	Day 1- Day 21
Secondary	Cmax	Maximum concentration of OC514 in blood plasma	Day 1-Day 4, Day 8, Day 16, Day 17
Secondary	Tmax	Time to maximum concentration	Day 1-Day 4, Day 8, Day 16, Day 17
Secondary	Cmin	Minimum concentration	Day 1-Day 4, Day 8, Day 16, Day 17
Secondary	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
Secondary	AUC (0-inf)	AUC from time zero to infinity	Day 1 and Day 2
Secondary	AUC (0-12)	AUC from time zero until 12 hours post dose	Day 3-Day 16
Secondary	t1/2	Elimination half life	Day 1-Day 4, Day 8, Day 16, Day 17
Secondary	?z or Kel	Apparent terminal elimination rate	Day 1-Day 4, Day 8, Day 16, Day 17
Secondary	CL/F and CL/Fss	Apparent clearance	Day 1-Day 4, Day 8, Day 16, Day 17
Secondary	Vz/F and Vz/Fss	Volume of distribution	Day 1-Day 4, Day 8, Day 16, Day 17
Secondary	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