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Comparative PK, Safety, Tolerability, Immunogenicity, and PD Profile Study of TUR03 and Soliris in Healthy Participants

NCT05863442 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-11-24

No results posted yet for this study

Summary

This study is designed as a randomized, double-blind, parallel-group study to evaluate the PK, safety, tolerability, immunogenicity, and PD of TUR03 compared to Soliris, when administered as a single IV infusion in healthy adult male participants.

Conditions

  • Healthy

Interventions

DRUG

Soliris 300 MG in 30 ML Injection

Active Comparator

DRUG

TUR03 300 MG in 30 ML Injection

Investigational medicinal Product, eculizumab - Turgut

Sponsors & Collaborators

  • Turgut Ardika PTY LTD

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-04-10
Primary Completion
2024-07-23
Completion
2024-10-05

Countries

  • Australia

Study Locations

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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 NCT05863442 on ClinicalTrials.gov