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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-12

Study Completion Date

2023-02-20

Brief Summary

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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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Detailed Description

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Conditions

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Cachexia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TCMCB07

once daily subcutaneous injection

Group Type EXPERIMENTAL

TCMCB07

Intervention Type DRUG

Subcutaneous injection of TCMCB07

Placebo

once daily subcutaneous injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching subcutaneous placebo

Interventions

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TCMCB07

Subcutaneous injection of TCMCB07

Intervention Type DRUG

Placebo

Matching subcutaneous placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes