Single-dose study of SAR441344 in healthy Chinese and Japanese participants

JRCT ID: jRCT2071220098

Registered date:31/01/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Healthy adult participants
• Date of first enrollment: 08/02/2023
• Target sample size: 36
• Countries of recruitment: South Korea,Japan
• Study type: Interventional

Intervention(s)

Drug: SAR441344
Pharmaceutical form: Injection, Route of administration: SC injection or IV infusion

Outcome(s)

• Primary Outcome: Pharmacokinetic (PK) parameters: at least Cmax, AUClast, and AUC

Secondary Outcome

- Assessment of adverse events (AE)/treatmentemergent
adverse events (TEAE)
- Clinical laboratory evaluations
- Vital signs and 12-lead electrocardiogram (ECG)
- Local tolerability at injection site
- Anti-drug antibodies (ADA)
- Plasma sCD40L concentration

Key inclusion & exclusion criteria

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

Include criteria

- East Asian (ethnic Chinese or Japanese) adult male or female 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, and laboratory tests.
- Laboratory parameters within the normal range (or defined screening threshold for the Investigator site), unless the Investigator considers an abnormality to be clinically
irrelevant for healthy participant.
- Body weight within the range from 50 to 100 kg, inclusive, if male; and between 45 and 90 kg, inclusive, if female; body mass index (BMI) within the range from 18.0 to 30.0 kg/m^2, inclusive.
- Contraceptive used by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breastfeeding.
- Capable of giving signed informed consent with the requirements and restrictions listed in the informed
consent form (ICF) and in this protocol.

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, gynecologic (if female), or infectious disease, or signs of acute illness.
- Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month).
- Blood donation, any volume, within 2 months before inclusion (Note: For a site in Japan, blood donation of 400 mL within 12 weeks [for male] or 16 weeks [for female], 200 mL within 4 weeks or apheresis donation within 2 weeks before the first IMP administration).
- Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure >=20 mmHg within 3 minutes when changing from supine to standing position.
- Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
- History or presence of drug or alcohol abuse.
Prior/concomitant therapy
- Any medication within 14 days before inclusion or within 5 times the elimination half-life or PD half-life of the medication (whichever is longer), with the exception of hormonal contraceptives.
- Participant must not have received any vaccination within the 4 weeks before inclusion and should adhere to vaccination restrictions for the study (ie, participant may not receive any vaccines from inclusion to EOS).
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.

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

Related Information

• Primary Sponsor: Tanaka Tomoyuki