Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TNM002 in Chinese Healthy Adults

Trinomab

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: TNM002

Study type: Interventional

Funder types: Industry

Identifiers

NCT05842798

TNM002-P1-CH01

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics properties of TNM002 following a single intramuscular dose in Chinese healthy adults.

Enrollment: 28 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male or female, 18-55 years of age;
2. Body mass index (BMI) within 19.0-26.0 kg/m2;

Exclusion criteria

1. Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation;
2. Severe drug or excipient allergy, or history of hypersensitivity to other therapeutic mAbs;
3. History of alcohol or other substance abuse.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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28 participants in 3 patient groups

Cohort 1: TNM002 35 μg/kg or placebo

Experimental group

Description:

Eight subjects will be randomly assigned to receive either TNM002 35 μg/kg or placebo at a 3:1 ratio (i.e. 6 subjects receive TNM002 and 2 with placebo)

Treatment:

Drug: TNM002

Drug: Placebo

Cohort 2: TNM002 100 μg/kg or placebo

Experimental group

Description:

Eight subjects will be randomly assigned to receive either TNM002 100 μg/kg or placebo at a 3:1 ratio (i.e. 6 subjects receive TNM002 and 2 with placebo)

Treatment:

Drug: TNM002

Drug: Placebo

Cohort 3：TNM002 250 μg/kg or placebo

Experimental group

Description:

Eight subjects will be randomly assigned to receive either TNM002 250 μg/kg or placebo at a 3:1 ratio (i.e. 6 subjects receive TNM002 and 2 with placebo)

Treatment:

Drug: TNM002

Drug: Placebo