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

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

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-15

Study Completion Date

2022-02-24

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Cohort 1: TNM002 35 μg/kg or placebo

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)

Group Type EXPERIMENTAL

TNM002

Intervention Type DRUG

TNM002, intramuscular injection

Placebo

Intervention Type DRUG

Placebo, intramuscular injection

Cohort 2: TNM002 100 μg/kg or placebo

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)

Group Type EXPERIMENTAL

TNM002

Intervention Type DRUG

TNM002, intramuscular injection

Placebo

Intervention Type DRUG

Placebo, intramuscular injection

Cohort 3：TNM002 250 μg/kg or placebo

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)

Group Type EXPERIMENTAL

TNM002

Intervention Type DRUG

TNM002, intramuscular injection

Placebo

Intervention Type DRUG

Placebo, intramuscular injection

Interventions

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TNM002

TNM002, intramuscular injection

Intervention Type DRUG

Placebo

Placebo, intramuscular injection

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes