A PK Comparability Study of Two Different Amlitelimab Drug Products in Healthy Participants

NCT ID: NCT05796479

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-28
• Study Completion Date: 2023-05-22

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

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group 1 (Part1)

Participants will receive a single SC dose of amlitelimab DP1 on Day 1.

Group Type: EXPERIMENTAL

Amlitelimab DP1

Intervention Type: DRUG

Injection solution 1

Subcutaneous

Group 2 (Part 2)

Participants will receive a single SC dose of amlitelimab DP1 on Day 1.

Group Type: EXPERIMENTAL

Amlitelimab DP1

Intervention Type: DRUG

Injection solution 1

Subcutaneous

Group 3 (Part 2)

Participants will receive a single SC dose of amlitelimab DP2 on Day 1.

Group Type: EXPERIMENTAL

Amlitelimab DP2

Intervention Type: DRUG

Injection solution 2

Subcutaneous

Interventions

Amlitelimab DP1

Injection solution 1

Subcutaneous

Intervention Type: DRUG

Amlitelimab DP2

Injection solution 2

Subcutaneous

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Clinical Pharmacology of Miami-Site Number: 8400001

Hialeah, Florida, United States

Countries

United States

Related Links

https://www.trialsummaries.com/Study/StudyDetails?id=25329&tenant=MT_SNY_9011

PKM17597 Plain Language Results Summary

Other Identifiers

PKM17597

Identifier Type: -

Identifier Source: org_study_id