Clinical trial NCT05858788: A Single Ascending Dose Study to Characterize the Pharmacokinetics, Safety, and Tolerability of SAR441566 in Healthy Adult Japanese Male Participants.
Official title: A Phase 1, Open Label, 3-treatment Period, 1-sequence, Cross-over Study to Evaluate Pharmacokinetics, Safety, and Tolerability After Single Ascending Oral Doses of SAR441566 in Healthy Adult Japanese Male Participants.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2023-05-15
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a cross-over, Phase 1, 3-treatment period single sequence study. The purpose of this study is to characterize pharmacokinetics (PK), safety, and tolerability of single ascending oral doses of SAR441566 in healthy male Japanese participants, 18-55 years of age.

Detailed description: The duration of the study for a participant will be up to approximately 65 days.

Eligibility criteria: Inclusion Criteria:

* Japanese participants whose Japanese ethnicity is defined according to the following criteria: born in Japan or born outside of Japan, and are descendent of 4 ethnic Japanese grandparents who were all born in Japan.
* Male participants between the ages of 18 and 55 years, inclusive
* Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination including 12-lead ECG, and clinical laboratory tests)
* Body weight between 50.0 and 100.0 kg, inclusive, and body mass index (BMI) between 18.0 and 30.0 kg/m\^2, inclusive.

Exclusion 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, dermatological (including phototoxic dermatitis), osteomuscular, articular, psychiatric, systemic, ocular, immune disorders or infectious disease, or signs of acute illness.
* Receipt of live (attenuated) vaccines within 3 months and/or non live vaccines (eg, COVID-19 vaccination) within 4 weeks prior to first dose on Day 1, or planned to receive these vaccines at any time throughout the study.
* History of tuberculosis and/or a positive QuantiFERON-TB Gold (QFT) test.
* Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis B core antibody (anti-HBc Ab), anti-hepatitis C virus antibody (anti-HCV Ab), anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab), SARS-CoV-2
* Any medication within 14 days before inclusion (before first study treatment administration) or within 5 times the elimination half-life or pharmacodynamic half-life of the medication whichever the longest.

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

Primary outcomes:
measure: Assessment of plasma pharmacokinetic (PK) parameters for SAR441566: Cmax
timeFrame: From Day 1 to Day 5 of each period (5 days per period)
measure: Assessment of plasma pharmacokinetic (PK) parameters for SAR441566: AUClast
timeFrame: From Day 1 to Day 5 of each period (5 days per period)
measure: Assessment of plasma pharmacokinetic (PK) parameters for SAR441566: AUC
timeFrame: From Day 1 to Day 5 of each period (5 days per period)
Secondary outcomes:
measure: Number of participants with adverse events (AE) and treatment-emergent adverse events (TEAEs)
timeFrame: Up to end of study visit (which will occur at latest day 37 of study)
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Parexel International-Site Number:8400001
state: California
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: