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

NCT04629131 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-11-07

No results posted yet for this study

Summary

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

Conditions

  • Healthy Adult Subjects

Interventions

BIOLOGICAL

TNM002 Dosage 1 (10 μg/kg)

TNM002 (human monoclonal antibody against tetanus toxin), 10 μg/kg, Intramuscular injection, given once.

BIOLOGICAL

Placebo

placebo to match TNM002 Dosage 1, given once

BIOLOGICAL

TNM002 Dosage 2 (35 μg/kg)

TNM002 (human monoclonal antibody against tetanus toxin), 35 μg/kg, Intramuscular injection, given once

BIOLOGICAL

Placebo

placebo to match TNM002 Dosage 2, given once

BIOLOGICAL

TNM002 Dosage 3 (100 μg/kg)

TNM002 (human monoclonal antibody against tetanus toxin), 100 μg/kg, Intramuscular injection, given once

BIOLOGICAL

Placebo

placebo to match TNM002 Dosage 3, given once

BIOLOGICAL

TNM002 Dosage 4 (250 μg/kg)

TNM002 (human monoclonal antibody against tetanus toxin), 250 μg/kg, Intramuscular injection, given once

BIOLOGICAL

Placebo

placebo to match TNM002 Dosage 4, given once

Sponsors & Collaborators

  • TIGERMED AUSTRALIA PTY LIMITED

    collaborator UNKNOWN

  • Zhuhai Trinomab Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Charlotte Lemech, FRACP · Scientia Clinical Research Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-25
Primary Completion
2021-08-13
Completion
2021-08-13

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04629131 on ClinicalTrials.gov