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A Phase 1, open-label, randomized, parallel study to evaluate the pharmacokinetics, safety, and tolerability of single-dose SAR443765 in healthy adult Japanese participants

Pharmacokinetics, safety, and tolerability of a single-dose of SAR443765 in healthy Japanese participants

Tanaka Tomoyuki

Sanofi K.K.

Tokyo Opera City Tower, 3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo 163-1488, Japan

clinical-trials-jp@sanofi.com

Clinical Study Unit

Sanofi K.K.

Tokyo Opera City Tower, 3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo 163-1488, Japan

+81-363013670

clinical-trials-jp@sanofi.com

Complete

Mar. 13, 2023

Interventional

randomized controlled trial

open(masking not used)

uncontrolled control

parallel assignment

other

Participants are eligible to be included in the study only if all of the following criteria apply:
- Japanese male or female participant, must be 18 to 45 years of age inclusive, at the time of signing the informed consent.
- Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
- Within 50.0 and 100.0 kg, inclusive, if male; and between 40.0 and 90.0 kg, inclusive, if female; and body mass index (BMI) within the range 18.0 and 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.

Participants are excluded from the study if any of the following criteria apply:
Medical conditions
- Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness, unless the investigator considers an abnormality to be not clinically significant.
- Subject has clinical signs and symptoms consistent with COVID-19, eg, fever, dry cough, dyspnea, loss of taste and smell, sore throat, fatigue or confirmed infection by appropriate laboratory test within the last 4 weeks prior to IMP administration. Subject who had severe course of COVID-19 (ie, hospitalization, extracorporeal membrane oxygenation [ECMO], mechanically ventilated).
- Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month).
- Blood donation of 400 mL within 12 weeks (male) or 16 weeks (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 >=30 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. Participants with a history of mild seasonal allergies might be included at Investigator's discretion.

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.

Both

Healthy adult participants

Drug: SAR443765
Pharmaceutical form: Solution for injection, Route of administration: SC injection in abdomen

Serum PK parameters at least Cmax, AUClast, and AUC

- Assessment of adverse events (AEs) /treatment-emergent adverse events (TEAEs)
- Local tolerability at injection site
- Anti-drug antibodies (ADA)

+81-92-283-7701

Feb. 09, 2023

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

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