A study to investigate the pharmacokinetics and safety with a single dose of SAR442970 in healthy adult Japanese participants

JRCT ID: jRCT2071230056

Registered date:30/08/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Healthy Volunteers
• Date of first enrollment: 26/09/2023
• Target sample size: 12
• Study type: Interventional

Intervention(s)

Drug: SAR442970
Pharmaceutical form: Solution for injection, Route of administration: Subcutaneous injection in abdomen

Outcome(s)

Primary Outcome

1. Assessment of Serum pharmacokinetic parameter Cmax, AUClast, and AUC
[Time Frame: Up to Day 50]

Secondary Outcome

1. Number of participants with adverse events (AE) and treatment-emergent adverse events (TEAEs)
[Time Frame: Up to Day 50]

2. Incidence of anti-SAR442970 antibodies (ADA)
[Time Frame: Up to Day 50]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 55age old
• Gender: Both

Include criteria

- Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
- Vital signs after 10 minutes resting in supine position within the following range:
90 mmHg <=systolic blood pressure (SBP) <140 mmHg
45 mmHg <=diastolic blood pressure (DBP) <90 mmHg
45 bpm <=pulse rate <100 bpm
- Standard 12-lead ECG parameters after 10 minutes resting in supine position in the following ranges: 45 bpm <=heart rate (HR) <100 bpm, 120 ms <PR <220 ms, QRS <120 ms, QTc (Fridericia algorithm recommended) <=450 ms, and normal ECG tracing unless the Investigator considers an ECG tracing abnormality to be not clinically relevant.
- 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. Hepatic transaminases (aspartate aminotransferase, alanine aminotransferase) should not exceed 1.25X the upper laboratory norm. A repeated sample can be collected and tested to confirm an abnormal test result.
- Body weight within 50.0 and 100.0 kg, inclusive; and body mass index (BMI) within the range 18.0 and 30.0 kg/m^2, inclusive.
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
- - Is a woman of nonchildbearing potential (WONCBP) OR
- - Is a woman of childbearing potential (WOCBP) and agrees to use a contraceptive method that is highly effective.
- Male participants are eligible to participate if they agree to the following during the study intervention period and for at least 50 days after the administration of study intervention:
- - Refrain from donating or cryopreserving sperm; Plus either:
- - - Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR
- - - Must agree to use contraception/barrier as detailed below
- - A male condom; the participant should also be advised of the benefit for a female partner to use a highly effective method of contraceptionas a condom may break or leak when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant.
- Capable of giving signed informed consent which includes compliance 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:
- 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.
- Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month).
- Participants with a history of tuberculosis regardless of treatment or a positive T-SPOT-TB blood test.
- Participants with a history of invasive opportunistic infections such as histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, Pneumocystis jirovecii, aspergillosis, irrespective of resolution.
- Participants with fever (temperature >38 C), or chronic persistent or recurring infection(s) requiring active treatment with antibiotics, antivirals or antifungals within 4 weeks prior to IMP administration or other frequent recurrent infections deemed unacceptable as per Investigator's judgement.
- Participants who received any live vaccination within 12 weeks or any non-live vaccination within 14 days of IMP administration or intend to receive any vaccination during the study.
- Positive result on any of the following tests: hepatitis B surface antigen (HBs Ag), anti-hepatitis B surface antibody (anti-HBs Ab, except for participants with HBs Ag negative and anti-HBs Ab positive results due to a clear vaccination history), anti-hepatitis B core antibody (anti-HBc Ab), anti-hepatitis C virus antibody (anti-HCV Ab), human immunodeficiency virus antigen/antibody (HIV Ag/Ab), rapid plasma reagin (RPR) and treponema pallidum latex agglutination (TPLA) for syphilis.
- Participants 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

Related Information

• Primary Sponsor: Tanaka Tomoyuki