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A Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic Profile of TNM005 in Healthy Adult Subjectsy

NCT06068608 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-07-11

No results posted yet for this study

Summary

The purpose of this clinical trial is to evaluate the safety and tolerability of TNM005 following a single dose by intramuscular (IM) administration in healthy adult subjects The main questions it aims to answer are:1. safety profile；2. PK properties 3. PD properties

Conditions

  • Varicella

Interventions

DRUG

TNM005

single,intramuscular injection

DRUG

Placebo

single,intramuscular injection

DRUG

VariZIG

a single dose of VARIZIG 625 IU,intramuscular injection

Sponsors & Collaborators

  • Zhuhai Trinomab Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Ahad Sabet, MD · ICON plc

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-09-12
Primary Completion
2024-12-31
Completion
2024-12-31
FDA Drug
Yes

Countries

  • United States

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 NCT06068608 on ClinicalTrials.gov