This is a 2-part, Phase 1 study, with 1 arm in Part 1 and a randomized parallel design in Part 2. The purpose of this study is to evaluate the comparability of pharmacokinetics, safety and tolerability of two different amlitelimab drug products (DPs) after administration of a single subcutaneus (SC) dose in healthy adult participants. Study details include: The study duration for a participant will be approximately 17 weeks. The study includes a screening period of up to 28 days, a 4-day institutionalization period, and a follow up period for approximately 89 days (9 visits).
The study duration for a participant will be approximately 17 weeks
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
32
Injection solution 1 Subcutaneous
Injection solution 2 Subcutaneous
Clinical Pharmacology of Miami-Site Number: 8400001
Hialeah, Florida, United States
Part 1: Maximum Plasma concentration observed (Cmax )
Cmax after administration of a single SC dose of amlitelimab DP 1
Time frame: From Day1 up to Day92 (end of study [EOS])
Part 1: Area under the curve from the time of dosing to the last measurable concentration (AUClast)
AUClast after administration of a single SC dose of amlitelimab DP 1
Time frame: From Day1 up to Day92 (EOS)
Part 1: Area under the plasma concentration versus time curve extrapolated to infinity (AUC)
AUC after administration of a single SC dose of amlitelimab DP 1
Time frame: From Day1 up to Day92 (EOS)
Part 2: Cmax of two different amlitelimab DPs (DP1 and DP2)
Cmax after administration of a single SC dose of amlitelimab DP 1 and DP2
Time frame: From Day1 up to Day92 (EOS)
Part 2: AUClast of two different amlitelimab DPs (DP1 and DP2)
AUClast after administration of a single SC dose of amlitelimab DP1 and DP 2
Time frame: From Day1 up to Day92 (EOS)
Part 2: AUC of two different amlitelimab DPs (DP1 and DP2)
AUC after administration of a single SC dose of amlitelimab DP1 and DP 2
Time frame: From Day1 up to Day92 (EOS)
Part 1 and Part 2: Incidence of adverse events (AE)/treatment-emergent adverse events (TEAEs)
Incidence of AEs and TEAEs after administration of amlitelimab will be reported.
Time frame: From the signing of the informed consent form (ICF) up to Day92 EOS visit
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