Comparative Study of 3 Tocilizumab Products in Normal Healthy Volunteeers

Sponsor
Syneos Health
Study ID
NCT04885829
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
May 31, 2021
Status verified
May 2022
Primary completion
May 4, 2023
Completion
May 4, 2023

Study Design

Enrollment
300 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: DRL_TC
    Subcutaneous injection of DRL's Tocilizumab
  • Active Comparator: RP and RMP
    Subcutaneous injection of Actemra and RoActemra (Commercially available Tocilizumab)

Primary Outcome Measure

To demonstrate the PK (Pharmacokinetics) similarity of DRL_TC vs RP, DRL_TC vs RMP and RP vs RMP. [ Time Frame: Period I pre-dose (1hour prior to drug administration), Days 1, 2, 3, 4, 5, 6, 7, 9, 11, 15, 18, 22, 29, 36, 43 and Period II - Day 1 (dosing), 2 ,3 , 4 , 5 , 6, 7, 9, 11, 15, 18, 22, 29 , 36 , 43 (-2 to +4 days) ]

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