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Completed

NCT Number: NCT05529849

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

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Key information

Conditions

Cachexia Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms Thinness Weight Loss

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Sciences -- Miami, Inc.

Miami, Florida, 33126, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TCMCB07

Drug

Subcutaneous injection of TCMCB07

Placebo

Drug

Matching subcutaneous placebo

Primary outcomes

  1. Number of people with an Adverse Event Assessment

    Time frame: 6 Months

    Adverse Event monitoring

  2. Number of participants with abnormal vital signs

    Time frame: 6 Months

    Assessment of vital signs

  3. Number of people with abnormal laboratory test results

    Time frame: 6 Months

    Analysis of clinical chemistry, hematology, and urinalysis

  4. 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

  5. Number of people with abnormal physical examinations

    Time frame: 6 Months

    Physical and injection site examination

Secondary outcomes

  1. Peak Plasma Concentration (Cmax)

    Time frame: 6 Months

    Non-compartmental techniques will be employed to obtain estimates of cmax

  2. Area under the plasma concentration versus time curve (AUC)

    Time frame: 6 months

    Non-compartmental techniques will be employed to obtain estimates of AUC

Sponsors and collaborators

Lead sponsor

Endevica Bio

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Sep 7, 2022
Registry last updated
Feb 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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