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Cancer CachexiaPhase 1NCT05264038

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

A Phase 1 study testing OC514 (Low dose), OC514 (Mid dose) and OC514 (High dose) in people with Cancer Cachexia, run by Oncocross Australia Pty Ltd. at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Cancer Cachexia
What is being tested?
OC514 (Low dose), OC514 (Mid dose) and OC514 (High dose)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
23 participants
Where
1 siteAustralia
Study dates
3 Mar 2022to 13 Mar 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy male or female volunteers, between 18 and 65 years of age, both inclusive.
  • BMI between 18 and 32 kg/m2 (inclusive) with a bodyweight >/= 50 kg at screening.
  • Medically healthy with no clinically significant medical history.
  • Adequate venous access.
  • Non-pregnant, non-lactating females.
  • Must be able to comply with the requirements of the study.

Who cannot join

  • History of any clinically significant disease or disorder.
  • History or presence of gastrointestinal, hepatic, or renal disease or any other condition or past surgical intervention (eg, cholecystectomy).
  • Has creatinine clearance < 60 mL/min.
  • 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.
  • 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.
  • Any positive laboratory-confirmed COVID-19 test at Screening or check-in.
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  • 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.
  • Had major surgery (general anesthetic) in the last 3 months or minor surgery (local anesthetic) in the last 1 month prior to Screening.
  • History of narrow angle glaucoma.
  • History of benign prostatic hyperplasia (BPH) with lower urinary tract symptoms.
  • Any clinically significant medical or psychiatric condition, medical/surgical procedure, or trauma within 4 weeks prior to the first IP administration.
  • Blood donation within 1 month of Screening or any blood donation/blood loss greater than 500 mL during the 3 months prior to Screening.
  • Abnormal vital signs.
  • 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.
  • 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.
  • History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the Investigator, to any components in the IP.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Nucleus network

    Melbourne

Other trials in Australia

About this study

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

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.

Read the detailed 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).

Conditions
Cancer Cachexia
Being tested
OC514 (Low dose), OC514 (Mid dose), OC514 (High dose), Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OC514 (Low dose)Drug

    Also called OC514

    Low dose level of OC514

  • OC514 (Mid dose)Drug

    Also called OC514

    Mid dose level of OC514

  • OC514 (High dose)Drug

    Also called OC514

    High dose level of OC514

  • PlaceboOther

    Placebo to match

Study groups in NCT05264038
Study groupRoleWhat they receive
Cohort 1ExperimentalParticipants will receive either low dose level of OC514 or placebo
Receives: Drug: OC514 (Low dose); Other: Placebo
Cohort 2ExperimentalParticipants will receive either mid dose level of OC514 or placebo
Receives: Drug: OC514 (Mid dose); Other: Placebo
Cohort 3ExperimentalParticipants will receive either high dose level of OC514 or placebo
Receives: Drug: OC514 (High dose); Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Day 1- Day 21

  2. Severity of TEAEs and treatment related TEAEs

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

    Measured: Day 1- Day 21

  3. Number of participants with abnormal clinically significant laboratory results

    Clinical laboratory includes hematology, and biochemistry

    Measured: Day 1 - Day 21

  4. Number of patients with abnormal vital signs

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

    Measured: Day 1- Day 21

  5. Number of participants with abnormal and clinically significant electrocardiogram (ECG)

    12-lead ECG will be taken

    Measured: Day 1 - Day 21

  6. Number of participants with abnormal urinalysis

    Dipstick test will be performed

    Measured: Day 1- Day 21

  7. Number of participants with abnormal coagulation test

    Prothrombin time, International normalization ratio, Activated partial thromboplastin time

    Measured: Day 1- Day 21

Secondary outcomes (11)

  1. Cmax

    Maximum concentration of OC514 in blood plasma

    Measured: Day 1-Day 4, Day 8, Day 16, Day 17

  2. Tmax

    Time to maximum concentration

    Measured: Day 1-Day 4, Day 8, Day 16, Day 17

  3. Cmin

    Minimum concentration

    Measured: Day 1-Day 4, Day 8, Day 16, Day 17

  4. AUC (0-last)

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

    Measured: Day 1-Day 4, Day 8, Day 16, Day 17

  5. AUC (0-inf)

    AUC from time zero to infinity

    Measured: Day 1 and Day 2

  6. AUC (0-12)

    AUC from time zero until 12 hours post dose

    Measured: Day 3-Day 16

  7. t1/2

    Elimination half life

    Measured: Day 1-Day 4, Day 8, Day 16, Day 17

  8. λz or Kel

    Apparent terminal elimination rate

    Measured: Day 1-Day 4, Day 8, Day 16, Day 17

  9. CL/F and CL/Fss

    Apparent clearance

    Measured: Day 1-Day 4, Day 8, Day 16, Day 17

  10. Vz/F and Vz/Fss

    Volume of distribution

    Measured: Day 1-Day 4, Day 8, Day 16, Day 17

  11. Effect of OC514 administration on QT prolongation

    12-lead ECG will be done

    Measured: Day 4, Day 8, Day 12, Day 16, Day 17, day 19

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2022
  2. Study start3 Mar 2022
  3. Primary completion7 Sep 2022
  4. Study completion13 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05264038
Sponsor's protocol ID
OC514-001
Status last verified
Mar 2023
First submitted
28 Jan 2022
Last updated
20 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing OC514 (Low dose), OC514 (Mid dose) and OC514 (High dose) in people with Cancer Cachexia, run by Oncocross Australia Pty Ltd. at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of treatment-emergent adverse events (TEAEs) and treatment related TEAEs (time frame: Day 1- Day 21). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05264038.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023.

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