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

Endevica Bio

Status and phase: Completed; Phase 1

Conditions: Cachexia

Treatments: Drug: TCMCB07; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05529849

205823

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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76 participants in 2 patient groups, including a placebo group

TCMCB07

Experimental group

Description:

once daily subcutaneous injection

Treatment:

Drug: TCMCB07

Placebo

Placebo Comparator group

Description:

once daily subcutaneous injection

Treatment:

Drug: Placebo