AzTrials
AzTrials

Healthy VolunteersPhase 1NCT05796479

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

A Phase 1 study testing Amlitelimab DP1 and Amlitelimab DP2 in people with Healthy Volunteers, run by Sanofi at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
Amlitelimab DP1 and Amlitelimab DP2
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
28 Apr 2022to 22 May 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Clinical Pharmacology of Miami-Site Number: 8400001

    Hialeah, Florida, 33014

Other trials in United States

About this study

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

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).

Read the detailed description

The study duration for a participant will be approximately 17 weeks

Being tested
Amlitelimab DP1, Amlitelimab DP2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Amlitelimab DP1Drug

    Injection solution 1

    Subcutaneous

  • Amlitelimab DP2Drug

    Injection solution 2

    Subcutaneous

Study groups in NCT05796479
Study groupRoleWhat they receive
Group 1 (Part1)ExperimentalParticipants will receive a single SC dose of amlitelimab DP1 on Day 1.
Receives: Drug: Amlitelimab DP1
Group 2 (Part 2)ExperimentalParticipants will receive a single SC dose of amlitelimab DP1 on Day 1.
Receives: Drug: Amlitelimab DP1
Group 3 (Part 2)ExperimentalParticipants will receive a single SC dose of amlitelimab DP2 on Day 1.
Receives: Drug: Amlitelimab DP2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Maximum Plasma concentration observed (Cmax )

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

    Measured: From Day1 up to Day92 (end of study [EOS])

  2. 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

    Measured: From Day1 up to Day92 (EOS)

  3. 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

    Measured: From Day1 up to Day92 (EOS)

  4. 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

    Measured: From Day1 up to Day92 (EOS)

  5. 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

    Measured: From Day1 up to Day92 (EOS)

  6. 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

    Measured: From Day1 up to Day92 (EOS)

Secondary outcomes (1)

  1. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2023
  2. Study start28 Apr 2022
  3. Primary completion22 May 2023
  4. Study completion22 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
2-part, open-label study with 1 arm in Part 1 and a randomized, 2 arms parallel design in Part 2
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05796479
Sponsor's protocol ID
PKM17597
Status last verified
Sep 2025
First submitted
13 Mar 2023
Last updated
19 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Amlitelimab DP1 and Amlitelimab DP2 in people with Healthy Volunteers, run by Sanofi at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Maximum Plasma concentration observed (Cmax ) (time frame: From Day1 up to Day92 (end of study [EOS])). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05796479.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in