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Comparative Study of 3 Tocilizumab Products in Normal Healthy Volunteeers

NCT04885829 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-01-05

No results posted yet for this study

Summary

A single dose, two period trial where participants will be given either of 3 Tocilizumab product on Day 1 during period 1 and either one of the remaining 2 Tocilizumab products on Day 1 period 2. There will be at least 6 weeks (42 days) of wash out between subsequent two period dosing. The maximum flexibility allowed between subsequent periods will be up to 9 weeks (63 days).

Names of the 3 tocilizumab products are DRL\_TC, RP and RMP. So if a participant receives DRL\_TC on Day 1 Period 1 then he/she will either receive RP/RMP on Day 1 Period 2.

Conditions

Interventions

DRUG

Tocilizumab Prefilled Syringe

0.9ml Subcutaneous pre-filled syringes containing 162mg of Tocilizumab.

Sponsors & Collaborators

  • Dr. Reddy's Laboratories Limited

    collaborator INDUSTRY

  • Syneos Health

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2021-05-31
Primary Completion
2023-05-04
Completion
2023-05-04
FDA Drug
Yes

Countries

  • Australia
  • India
  • New Zealand

Study Locations

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Entities

Diseases
Companies

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 NCT04885829 on ClinicalTrials.gov