A Study to Assess the Safety, Tolerability and Pharmacokinetics of TCMCB07 in Single and Multiple Ascending Doses in Health Subjects

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cachexia

Intervention / Treatment
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* Drug: TCMCB07
* Drug: TCMCB07 Matching Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TCMCB07<br>once daily subcutaneous injection | Drug: TCMCB07<br>* Subcutaneous injection of TCMCB07<br>|
| Placebo Comparator: TCMCB07 Matching Placebo<br>once daily subcutaneous injection | Drug: TCMCB07 Matching Placebo<br>* Matching subcutaneous placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of people with an Adverse Event Assessment | Adverse Event monitoring | 6 Months | 
| Number of participants with abnormal vital signs | Assessment of vital signs | 6 Months | 
| Number of people with abnormal laboratory test results | Analysis of clinical chemistry, hematology, and urinalysis | 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 | 6 Months | 
| Number of people with abnormal physical examinations | Physical and injection site examination | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax) | Non-compartmental techniques will be employed to obtain estimates of cmax | 6 Months | 
| Area under the plasma concentration versus time curve (AUC) | Non-compartmental techniques will be employed to obtain estimates of AUC | 6 months |