NCT04885829

Comparative Study of 3 Tocilizumab Products in Normal Healthy Volunteeers

A Single Dose, Double-Blind, Two-Period, Crossover, Comparative Pharmacokinetic Study of Three Tocilizumab Products Administered by the Subcutaneous Route to Normal Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Syneos Health · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

The study will be conducted at 4 sites (2 in New Zealand, 1 in Australia and 1 in India) The three pairwise product comparisons (DRL\_TC vs. RP; DRL\_TC vs RMP and RP vs. RMP)will be performed in parallel. Each comparison will be separately considered. Study subjectswill be randomly assigned in a 1:1:1 ratio to one of the comparisons and within eachcomparison subjects will be randomized in a 1:1 ratio to one of the two possible productsequences The total duration of the individual subject study participation will be at least 12weeks. Dosing for period 1 will be on on day 1 followed by washout out period of upto 9weeks. Dosing for Period 2 will be on Day 1. Subjects who complete the study and are found to be positive for anti-drug antibodies (ADA)on Day 29 and/or Day 43 period 2, will be followed up every 90 days for immunogenicitysampling up to approximately one year post Period II dosing, or until two consecutive sampleshave been negative for ADA, whichever is earlier. Early dropouts will be tested forimmunogenicity at the time of EOS and if they are positive for ADAs they will be followed-up ifpossible at 90 days intervals starting from the last received dose (either Period I or Period II) ina similar manner. 300 NHV (Normal Healthy Volunteers) will be included in the study as justified under samplesize justification. After the data of these 300 volunteers become available a blinded samplesize re-estimation (BSSR) will be performed to reconfirm the statistical assumptions of thestudy design and depending upon the outcome of the BSSR, study may be stopped or thesample size may be increased, as needed to attain the required statistical power.

Conditions

• Rheumatoid Arthritis
• Giant Cell Arteritis

Interventions

Type	Name	Description
DRUG	Tocilizumab Prefilled Syringe	0.9ml Subcutaneous pre-filled syringes containing 162mg of Tocilizumab.

Timeline

• Start date: 2021-05-31
• Primary completion: 2023-05-04
• Completion: 2023-05-04
• First posted: 2021-05-13
• Last updated: 2024-01-05

Locations

4 sites across 3 countries: Australia, India, New Zealand

Regulatory

• FDA-regulated drug study