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

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

November 25, 2020

Primary Completion Date

August 13, 2021

Study Completion Date

August 13, 2021

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

Trial Locations (1)

2031

Scientia Clinical Research, Sydney

All Listed Sponsors
collaborator

TIGERMED AUSTRALIA PTY LIMITED

UNKNOWN

lead

Zhuhai Trinomab Pharmaceutical Co., Ltd.

INDUSTRY

NCT04629131 - Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TNM002 in Healthy Adults | Biotech Hunter | Biotech Hunter