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

NCT05529849 | Completed Phase 1 FDA Drug

• 1 other identifier: 205823
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cachexia

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Peak Plasma Concentration (Cmax)

  6 Months

• Area under the plasma concentration versus time curve (AUC)

  6 months

Study Arms (2)

TCMCB07

EXPERIMENTAL

once daily subcutaneous injection

Drug: TCMCB07

Placebo

PLACEBO COMPARATOR

once daily subcutaneous injection

Drug: Placebo

Interventions

TCMCB07 DRUG

Subcutaneous injection of TCMCB07

TCMCB07

Placebo DRUG

Matching subcutaneous placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Endevica Bio: lead

Study Sites (1)

Quotient Sciences -- Miami, Inc.

Miami, Florida, 33126, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Cachexia

Condition Hierarchy (Ancestors)

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

Study Officials

• Maria Bermudez, MD, CPI

  Quotient Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: September 7, 2022
• Study Start: July 12, 2022
• Primary Completion: December 12, 2022
• Study Completion: February 20, 2023
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)