Healthy volunteers help compare two forms of experimental drug amlitelimab
NCT ID NCT05796479
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early-stage study tested two different versions of the experimental drug amlitelimab in 32 healthy adults. The goal was to see how the body absorbs and processes each version and to check for any safety issues. Participants received a single injection and were monitored for about 17 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- amlitelimab
- What could go wrong
- This is an early-phase study in healthy volunteers, not patients, so it cannot show whether the drug works for any disease. The main goal is just to compare two versions of the drug.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
32 people
The number who actually took part.
- Started
-
Apr 2022
- Finished
-
May 2023
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Clinical Pharmacology of Miami-Site Number: 8400001
Hialeah, Florida, 33014, United States
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