A Phase 1, open label study to evaluate the pharmacokinetics, safety and tolerability of single subcutaneous dose amlitelimab in healthy adult participants.

JRCT ID: jRCT2071220049

Registered date:31/08/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Healthy adult participants
• Date of first enrollment: 09/09/2022
• Target sample size: 24
• Countries of recruitment: South Korea,Japan
• Study type: Interventional

Intervention(s)

Drug: SAR445229
Pharmaceutical form: Vial, Route of administration: Subcutaneous Injection

Outcome(s)

• Primary Outcome: PK parameters: at least tmax, Cmax, AUClast, AUC, t1/2z, tlast, CL/F, Vz/F

Secondary Outcome

1. Assessment of adverse events /treatment-emergent adverse events, clinical laboratory evaluations, vital signs, electrocardiogram and local tolerability at injection site.
2. Anti-drug antibodies

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 45age old
• Gender: Both

Include criteria

- Chinese or Japanese male and female adult participants, between 20 and 45 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, laboratory tests.
- Vital signs in supine position after 10 minutes resting within the following ranges:
- 95 mmHg < systolic blood pressure (SBP) <140 mmHg.
- 45 mmHg < diastolic blood pressure (DBP) <90 mmHg.
- 45 bpm < heart rate (HR) <100 bpm."
- Body weight within the range from 50 to 100 kg and body mass index (BMI) within the range from 18-30 kg/m^2 (inclusive).
- Capable of giving signed informed consent includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

NOTE: Other Inclusion criteria may apply.

Exclude criteria

Participants are excluded from the study if any of the following criteria apply:
Medical conditions
- 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.
- Serious infections requiring hospitalization within 30 days prior to screening or any active or chronic infection requiring systemic treatment within 2 weeks prior to baseline (1 week in the event of superficial skin infections).
- Have basal or squamous cell skin cancer in the last 3 years prior to baseline. Any other malignancies not in remission within the past 5 years prior to baseline (excluding in situ cervical carcinoma that has been excised and cured).
- Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month).

Prior/concomitant therapy
- 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.
- Treatment with a live (attenuated) immunization within 12 weeks prior to IMP administration; administrations of COVID-19 vaccine within 14 days prior to IMP administration.

Other exclusions
- Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.

NOTE: Other Exclusion criteria may apply.

Related Information

• Primary Sponsor: Tanaka Tomoyuki