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

February 19, 2024 updated by: Endevica Bio

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33126
        • Quotient Sciences -- Miami, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TCMCB07
once daily subcutaneous injection
Drug: TCMCB07
Subcutaneous injection of TCMCB07
Placebo Comparator: Placebo
once daily subcutaneous injection
Drug: Placebo
Matching subcutaneous placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Endevica Bio

Investigators

  • Principal Investigator: Maria Bermudez, MD, CPI, Quotient Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2022

Primary Completion (Actual)

December 12, 2022

Study Completion (Actual)

February 20, 2023

Study Registration Dates

First Submitted

July 28, 2022

First Submitted That Met QC Criteria

September 2, 2022

First Posted (Actual)

September 7, 2022

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 205823

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe