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

Oncocross

Status and phase: Completed; Phase 1

Conditions: Cancer Cachexia

Treatments: Other: Placebo; Drug: OC514 (High dose); Drug: OC514 (Low dose); Drug: OC514 (Mid dose)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05264038

OC514-001

Details and patient eligibility

About

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.

Full 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).

Enrollment: 23 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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23 participants in 3 patient groups

Cohort 1

Experimental group

Description:

Participants will receive either low dose level of OC514 or placebo

Treatment:

Other: Placebo

Drug: OC514 (Low dose)

Cohort 2

Experimental group

Description:

Participants will receive either mid dose level of OC514 or placebo

Treatment:

Other: Placebo

Drug: OC514 (Mid dose)

Cohort 3

Experimental group

Description:

Participants will receive either high dose level of OC514 or placebo

Treatment:

Other: Placebo

Drug: OC514 (High dose)