CachexiaPhase 1NCT05529849
A Study to Assess the Safety, Tolerability and Pharmacokinetics of TCMCB07 in Single and Multiple Ascending Doses in Health Subjects
A Phase 1 study testing TCMCB07 in people with Cachexia, run by Endevica Bio at 1 site in United States.
Trial summary
This study will test an experimental drug named TCMCB07 for the treatment of cancer cachexia. Cachexia is a syndrome characterized by weight loss, anorexia, weakness or lack of energy, and anemia. Cachexia occurs in many cancers, usually at the advanced stages of disease. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cachexia
- What is being tested?
- TCMCB07
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2022to 20 Feb 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females (WONCBP), aged 18 to 55 years inclusive, at time of signing informed consent.
- Body mass index 18.0 to 30.0 kg/m2 as measured at Screening or, if outside this range, considered not clinically significant by the investigator.
- Weight ≥ 50 kg at Screening
Who cannot join
- Serious adverse reaction or serious known hypersensitivity to melanocortins or polyethylene glycol.
- Evidence of current severe acute respiratory syndrome coronavirus 2 infection.
- Clinically significant abnormal clinical chemistry, hematology, or urinalysis as judged by the investigator.
- Subjects who have received any IP in a clinical research study within 5 half-lives or within 30 days prior to first dose. However, in no event shall the time between last receipt of IP and first dose be less than 30 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
Quotient Sciences -- Miami, Inc.
Miami, Florida, 33126
About this study
Official title: A Two-Part Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Subcutaneous Doses of TCMCB07 on Healthy Male and Female Subjects
This study will test an experimental drug named TCMCB07 for the treatment of cancer cachexia. Cachexia is a syndrome characterized by weight loss, anorexia, weakness or lack of energy, and anemia. Cachexia occurs in many cancers, usually at the advanced stages of disease.
- Conditions
- Cachexia
- Being tested
- TCMCB07, Placebo
- Medical subject headings
- Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCMCB07Drug
Subcutaneous injection of TCMCB07
PlaceboDrug
Matching subcutaneous placebo
| Study group | Role | What they receive |
|---|---|---|
| TCMCB07 | Experimental | once daily subcutaneous injection Receives: Drug: TCMCB07 |
| Placebo | Placebo comparator | once daily subcutaneous injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of people with an Adverse Event Assessment
Adverse Event monitoring
Measured: 6 Months
Number of participants with abnormal vital signs
Assessment of vital signs
Measured: 6 Months
Number of people with abnormal laboratory test results
Analysis of clinical chemistry, hematology, and urinalysis
Measured: 6 Months
Number of people with abnormal Electrocardiograms
12-lead ECGs will be used and an assessment of any clinically significant abnormality from baseline will be reported as an AE
Measured: 6 Months
Number of people with abnormal physical examinations
Physical and injection site examination
Measured: 6 Months
Secondary outcomes (2)
Peak Plasma Concentration (Cmax)
Non-compartmental techniques will be employed to obtain estimates of cmax
Measured: 6 Months
Area under the plasma concentration versus time curve (AUC)
Non-compartmental techniques will be employed to obtain estimates of AUC
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start12 Jul 2022
- Primary completion12 Dec 2022
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CachexiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endevica Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria Bermudez, MD, CPI, Principal investigator, Quotient Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05529849
- Sponsor's protocol ID
- 205823
- Status last verified
- Feb 2024
- First submitted
- 28 Jul 2022
- Last updated
- 21 Feb 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Part Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Subcutaneous Doses of TCMCB07 on Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT05529849
- Acronym / sponsor ID
- 205823
- Conditions
- Cachexia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Endevica BioIndustry (pharma, biotech, devices)
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- 12 Dec 2022 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 7 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test an experimental drug named TCMCB07 for the treatment of cancer cachexia. Cachexia is a syndrome characterized by weight loss, anorexia, weakness or lack of energy, and anemia. Cachexia occurs in many cancers, usually at the advanced stages of disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCMCB07 | Experimental | Drug: TCMCB07once daily subcutaneous injection |
| Placebo | Placebo comparator | Drug: Placeboonce daily subcutaneous injection |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy males and females (WONCBP), aged 18 to 55 years inclusive, at time of signing informed consent.
- Body mass index 18.0 to 30.0 kg/m2 as measured at Screening or, if outside this range, considered not clinically significant by the investigator.
- Weight ≥ 50 kg at Screening
Key exclusion criteria (4 listed)
- Serious adverse reaction or serious known hypersensitivity to melanocortins or polyethylene glycol.
- Evidence of current severe acute respiratory syndrome coronavirus 2 infection.
- Clinically significant abnormal clinical chemistry, hematology, or urinalysis as judged by the investigator.
- Subjects who have received any IP in a clinical research study within 5 half-lives or within 30 days prior to first dose. However, in no event shall the time between last receipt of IP and first dose be less than 30 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TCMCB07Subcutaneous injection of TCMCB07 | Drug | TCMCB07 |
| PlaceboMatching subcutaneous placebo | Drug | Placebo |
Primary outcome
Number of people with an Adverse Event Assessment
Time frame: 6 Months
Adverse Event monitoring
Number of participants with abnormal vital signs
Time frame: 6 Months
Assessment of vital signs
Number of people with abnormal laboratory test results
Time frame: 6 Months
Analysis of clinical chemistry, hematology, and urinalysis
Number of people with abnormal Electrocardiograms
Time frame: 6 Months
12-lead ECGs will be used and an assessment of any clinically significant abnormality from baseline will be reported as an AE
Number of people with abnormal physical examinations
Time frame: 6 Months
Physical and injection site examination
2 secondary outcomes
Peak Plasma Concentration (Cmax)
Time frame: 6 Months
Area under the plasma concentration versus time curve (AUC)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Bermudez, MD, CPI principal investigator
Quotient Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TCMCB07 in people with Cachexia, run by Endevica Bio at 1 site in United States.
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 3 inclusion and 4 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 21 Feb 2024. 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 United States. 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. Some participants in this study may receive a placebo. 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 people with an Adverse Event Assessment (time frame: 6 Months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2024.