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

Cachexia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05529849
• Other study ID #: 205823
• Status: Completed
• Phase: Phase 1
• Start date: July 12, 2022
• Est. completion date: February 20, 2023

Study information

• Verified date: February 2024
• Source: Endevica Bio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: February 20, 2023
• Est. primary completion date: December 12, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cachexia

Intervention

Drug:
• TCMCB07
Subcutaneous injection of TCMCB07
• Placebo
Matching subcutaneous placebo

Locations

Country	Name	City	State
United States	Quotient Sciences -- Miami, Inc.	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Endevica Bio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of people with an Adverse Event Assessment	Adverse Event monitoring	6 Months
Primary	Number of participants with abnormal vital signs	Assessment of vital signs	6 Months
Primary	Number of people with abnormal laboratory test results	Analysis of clinical chemistry, hematology, and urinalysis	6 Months
Primary	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
Primary	Number of people with abnormal physical examinations	Physical and injection site examination	6 Months
Secondary	Peak Plasma Concentration (Cmax)	Non-compartmental techniques will be employed to obtain estimates of cmax	6 Months
Secondary	Area under the plasma concentration versus time curve (AUC)	Non-compartmental techniques will be employed to obtain estimates of AUC	6 months

External Links

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