Clinical trial NCT05796479: A PK Comparability Study of Two Different Amlitelimab Drug Products in Healthy Participants
Official title: A 2-part, Open Label, Phase 1 Study to Investigate the Pharmacokinetics, Safety and Tolerability of Two Different Amlitelimab Drug Products After Administration of a Single Subcutaneous Dose in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2023-04-03
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2-part, open-label study with 1 arm in Part 1 and a randomized, 2 arms parallel design in Part 2
Primary purpose: OTHER

Brief summary: 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).

Detailed description: The study duration for a participant will be approximately 17 weeks

Eligibility criteria: Inclusion Criteria:

* Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, ECG, and laboratory tests
* Body weight within 55 to 100 kg and body mass index (BMI) within the range 18-30 kg/m2 (inclusive)
* Male or female of childbearing potential are required to either practice true abstinence consistent with their preferred and usual lifestyle or use highly effective contraceptive methods for the entire duration of the treatment until 4 months after the investigational medicinal product (IMP) dosing.

Exclusion Criteria:

* Any history or presence of clinically relevant immunologic, cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness, unless the investigator considers an abnormality to be not clinically significant.
* Participants with a history of helminthic infection or invasive opportunistic infections such as histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, Pneumocystis jirovecii, aspergillosis, irrespective of resolution.
* Serious infections requiring hospitalization within 30 days prior to screening or any active infection requiring treatment during screening.
* Current or past diagnosis of malignancies within the last 5 years prior to screening (except documented history of cured non-metastatic squamous or basal cell skin carcinoma or cervical carcinoma in situ).
* Presence or history of drug hypersensitivity or allergic disease diagnosed and treated by a physician.
* Evidence of active or latent tuberculosis (TB XE ' TB ' \\f Abbreviation \\t 'tuberculosis ' ) as documented by medical history and examination; TB testing via a positive (not indeterminate) QuantiFERON TB Gold test
* If female, pregnancy (defined as positive beta human chorionic gonadotropin \[β-HCG\] test), or lactating. - Received a live (attenuated) immunization within 12 weeks prior to inclusion or non-live immunization within 4 weeks prior to inclusion.
* Any medication, with the exception of hormonal contraception, within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, whichever is longer, and any biologics (antibody or its derivatives) given within 4 months before inclusion.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Part 1: Maximum Plasma concentration observed (Cmax )
timeFrame: From Day1 up to Day92 (end of study [EOS])
measure: Part 1: Area under the curve from the time of dosing to the last measurable concentration (AUClast)
timeFrame: From Day1 up to Day92 (EOS)
measure: Part 1: Area under the plasma concentration versus time curve extrapolated to infinity (AUC)
timeFrame: From Day1 up to Day92 (EOS)
measure: Part 2: Cmax of two different amlitelimab DPs (DP1 and DP2)
timeFrame: From Day1 up to Day92 (EOS)
measure: Part 2: AUClast of two different amlitelimab DPs (DP1 and DP2)
timeFrame: From Day1 up to Day92 (EOS)
measure: Part 2: AUC of two different amlitelimab DPs (DP1 and DP2)
timeFrame: From Day1 up to Day92 (EOS)
Secondary outcomes:
measure: Part 1 and Part 2: Incidence of adverse events (AE)/treatment-emergent adverse events (TEAEs)
timeFrame: From the signing of the informed consent form (ICF) up to Day92 EOS visit
Other outcomes:
Locations:
city: Hialeah
country: United States
facility: Clinical Pharmacology of Miami-Site Number: 8400001
state: Florida
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: