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

NCT05264038 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2023-03-20

No results posted yet for this study

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.

Conditions

  • Cancer Cachexia

Interventions

DRUG

OC514 (Low dose)

Low dose level of OC514

DRUG

OC514 (Mid dose)

Mid dose level of OC514

DRUG

OC514 (High dose)

High dose level of OC514

OTHER

Placebo

Placebo to match

Sponsors & Collaborators

  • Oncocross Australia Pty Ltd.

    lead INDUSTRY

Principal Investigators

  • Ofer Gonen, Dr. · Nucleus Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-03
Primary Completion
2022-09-07
Completion
2023-03-13

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05264038 on ClinicalTrials.gov