Nutritional and Metabolic Diseases

All Conditions

Symptoms and General Pathology

Wasting Syndrome

Cachexia

Weight Loss

Body Weight

Body Weight Changes

Thinness

Participants will receive either low dose level of OC514 or placebo

Participants will receive either mid dose level of OC514 or placebo

Participants will receive either high dose level of OC514 or placebo

OC514 (Low dose)

OC514 (Mid dose)

OC514 (High dose)

Placebo

Ofer Gonen, Dr.

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.

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).

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

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

Clinical laboratory includes hematology, and biochemistry

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

Prothrombin time, International normalization ratio, Activated partial thromboplastin time

Maximum concentration of OC514 in blood plasma

Area under the time concentration curve from time zero to last measurable concentration

AUC from time zero until 12 hours post dose

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A First in Human Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics Effects of OC514	NCT05264038	Cancer Cachexia	OC514 (Low dose... OC514 (Mid dose... OC514 (High dos... Placebo	18 Years - 65 Years	Oncocross Co. Ltd.
A First in Human Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics Effects of OC514	NCT05264038	Cancer Cachexia	OC514 (Low dose... OC514 (Mid dose... OC514 (High dos... Placebo	18 Years - 65 Years	Oncocross Co. Ltd.
A First in Human Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics Effects of OC514	NCT05264038	Cancer Cachexia	OC514 (Low dose... OC514 (Mid dose... OC514 (High dos... Placebo	18 Years - 65 Years	Oncocross Co. Ltd.

Spots Global Cancer Trial Database for oc514 (high dose)