Clinical Trials Logo

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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05264038
Study type Interventional
Source Oncocross Co. Ltd.
Contact
Status Completed
Phase Phase 1
Start date March 3, 2022
Completion date March 13, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT02553187 - A Prospective, Randomized, Controlled, Multicenter Study of Kanglaite Injection for the Treatment of Cancer Cachexia Phase 4
Recruiting NCT02848807 - Chemotherapy-related Toxicity, Nutritional Status and Quality of Life N/A
Active, not recruiting NCT01206335 - Open Label Study With OHR/AVR118 in Advanced Cancer Patients With Anorexia-Cachexia Phase 2
Completed NCT00378131 - Placebo Controlled, Randomized Safety and Efficacy Study of RC-1291 in Cancer Anorexia/Cachexia Phase 2
Completed NCT02359123 - Cannabics Capsules as Treatment to Improve Cancer Related CACS in Advanced Cancer Patients N/A
Completed NCT00267358 - Placebo Controlled, Randomized Safety and Efficacy Study of RC-1291 in Cancer Anorexia/Cachexia. Phase 2
Completed NCT03144128 - Vitamin D for Muscle Metabolic Function in Cancer Cachexia N/A
Completed NCT01614990 - Pilot Clinical Trial of Repeated Doses of Macimorelin to Assess Safety and Efficacy in Patients With Cancer Cachexia Phase 2
Recruiting NCT04065815 - Protein-rich Nutritional Therapy Combined With Time-efficient Exercise in Cancer Therapy N/A
Recruiting NCT04067167 - Flexi Band Resistance Training Versus EMS Exercise in Patients With the Diagnosis of Malignant Diseases N/A
Active, not recruiting NCT03851133 - Florida Pancreas Collaborative Next Generation Biobank
Recruiting NCT04127981 - Medical Imaging of Cachexia N/A
Not yet recruiting NCT05262192 - Nutrition Education and Quality of Life in Cancer Cachexia N/A
Completed NCT04153019 - PSYCHO-EDUCATIONAL AND REHABILITATIVE INTERVENTION FOR CANCER CACHEXIA (PRICC) N/A
Terminated NCT02066363 - Study of Parenteral Nutrition to Patients With Gastrointestinal Cancer N/A
Terminated NCT01505764 - The Role of Ghrelin in Cancer Cachexia Phase 2
Completed NCT00219817 - Safety and Efficacy of RC-1291 HCl in Patients With Cancer Related Anorexia and Weight Loss Phase 2
Completed NCT00094562 - A Fish Oil Supplement to Maintain Body Weight in Patients With Disease-Related Weight Loss Phase 2
Recruiting NCT04131478 - Effect of Gene Polymorphisms on the Pathogenesis of Cancer Cachexia
Recruiting NCT05915325 - Physical Training for Elderly Cancer Patients With Cachexia N/A