MedTrace Logo

Study of Felzartamab in Healthy Adult Subjects

NCT06285201 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-08-28

No results posted yet for this study

Summary

A Phase 1 Clinical Study to Evaluate the Pharmacokinetic Comparability, Safety, Tolerability, and Immunogenicity of Felzartamab for Injection Pre- and Post-changes of Process in Healthy Male Adult Subjects in China (Randomized, Double-blind, Single-dose, Two-formulation, Two-sequence, Two-period Crossover Design)

Conditions

  • Healthy

Interventions

DRUG

T

8 mg/kg IV of Test drug manufactured by I-Mab Biopharma(Hangzhou)

DRUG

R

8 mg/kg IV of Test drug manufactured by Patheon Italia

Sponsors & Collaborators

  • TJ Biopharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Xiaojiao Li, Doctor · The First Hospital of Jilin University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-27
Primary Completion
2024-08-15
Completion
2024-08-15

Countries

  • China

Study Locations

More Related Trials

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 NCT06285201 on ClinicalTrials.gov