Cachexia
Conditions
Brief 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.
Interventions
DRUGTCMCB07
Subcutaneous injection of TCMCB07
DRUGPlacebo
Matching subcutaneous placebo
Sponsors
Endevica Bio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with abnormal vital signs | 6 Months | Assessment of vital signs |
| Number of people with abnormal Electrocardiograms | 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 | 6 Months | Physical and injection site examination |
| Number of people with an Adverse Event Assessment | 6 Months | Adverse Event monitoring |
| Number of people with abnormal laboratory test results | 6 Months | Analysis of clinical chemistry, hematology, and urinalysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC) | 6 months | Non-compartmental techniques will be employed to obtain estimates of AUC |
| Peak Plasma Concentration (Cmax) | 6 Months | Non-compartmental techniques will be employed to obtain estimates of cmax |
Countries
United States
Outcome results
None listed