Pharmacokinetics and Safety in Healthy Volunteers

Sponsor
Boehringer Ingelheim
Study ID
NCT02045979
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

Investigate the pharmacokinetics, safety and tolerability of BI695501 and to establish pharmacokinetic similarity of BI 695501 to adalimumab.

Key Dates

Start date
Jan 31, 2014
Status verified
Sep 2017
Primary completion
Jun 20, 2014
Completion
Jun 20, 2014

Study Design

Enrollment
327 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BI 695501
    Subject to receive one subcutaneous (s.c.) injection from a prefilled syringe containing BI 695501
  • Active Comparator: adalimumab-EU source
    Subject to receive one subcutaneous (s.c.) injection from a prefilled syringe containing adalimumab-EU source
  • Active Comparator: adalimumab-US source
    Subject to receive one subcutaneous (s.c.) injection from a prefilled syringe containing adalimumab-US source

Primary Outcome Measure

Area Under the Concentration Time Curve (AUC) From Time Zero to Infinity (AUC 0-∞) of BI 695501, US-licensed Humira® or EU-approved Humira® [ Time Frame: at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 1032, 1320 h post dosing and on day 71 post dosing. ]

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