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

NCT05796479 | Completed Phase 1 FDA Drug

• 1 other identifier: PKM17597
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (6)

• Part 1: Maximum Plasma concentration observed (Cmax )

  Cmax after administration of a single SC dose of amlitelimab DP 1

  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

  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

  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

  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

  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

  From Day1 up to Day92 (EOS)

Secondary Outcomes (1)

• Part 1 and Part 2: Incidence of adverse events (AE)/treatment-emergent adverse events (TEAEs)

  From the signing of the informed consent form (ICF) up to Day92 EOS visit

Study Arms (3)

Group 1 (Part1)

EXPERIMENTAL

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

Drug: Amlitelimab DP1

Group 2 (Part 2)

EXPERIMENTAL

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

Drug: Amlitelimab DP1

Group 3 (Part 2)

EXPERIMENTAL

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

Drug: Amlitelimab DP2

Interventions

Amlitelimab DP1 DRUG

Injection solution 1 Subcutaneous

Group 1 (Part1); Group 2 (Part 2)

Amlitelimab DP2 DRUG

Injection solution 2 Subcutaneous

Group 3 (Part 2)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Clinical Pharmacology of Miami-Site Number: 8400001

Hialeah, Florida, 33014, United States

Location

Related Links

• PKM17597 Plain Language Results Summary

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2-part, open-label study with 1 arm in Part 1 and a randomized, 2 arms parallel design in Part 2

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: April 3, 2023
• Study Start: April 28, 2022
• Primary Completion: May 22, 2023
• Study Completion: May 22, 2023
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)