A randomized, double-blind, placebo-controlled single and multiple ascending dose study of the safety, tolerability and pharmacokinetics of oral doses of SAR443122 in healthy adult subjects.

A randomized, double-blind, placebo-controlled single and multiple ascending dose study of the safety, tolerability and pharmacokinetics of oral doses of SAR443122 in healthy adult subjects. - SAD and MAD of SAR443122

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48479

Enrollment

Registered

2019-06-17

Start date

2019-06-27

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Auto immune disease

Interventions

Group 1a: Group 1 day 1

SAR443122 10 milligrams (mg) or placebo

once fasted Group 2 day 1

SAR443122 30 mg or placebo

once fasted Group 3 day 1

SAR443122 100 mg or placebo

once fasted Group 4 day 1

SAR443122 200 mg or placebo

once fasted Group 5 day 1

SAR443122 400 mg or placebo

once fasted Group 6 day 1

SAR443122 X mg or placebo

once fasted Group 1b: 9 volunteers Period 1 Once 100 milligrams (mg) of SAR443122 as capsules by mouth under fasting conditions Period 2: Once 100 mg of SAR443122 as capsules by mouth under fasting

SAR443122 W mg or placebo

once a day fasted Group 9: Day 1-14

once a day fasted Group 10: Day 1-14

SAR443122 Y mg or placebo

once a day fasted Group 11: Day 1-14

SAR443122 Z mg or placebo

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male or female subjects 18 - 55 years 50 - 100 kg BMI 18.0 - 30.0 kg/m2

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Design outcomes

Secondary

Measure	Time frame
To determine the pharmacokinetic (PK) parameters of SAR443122 after single ascending oral doses in healthy adult subjects To determine the pharmacokinetic parameters of SAR443122 after ascending repeated oral doses in healthy adult subjects	—

Primary

Measure	Time frame
To assess the tolerability and safety of SAR443122 after single ascending oral doses in healthy adult subjects. To explore relative bioavailability between study formulation (SF) and solid dosage form (SDF) formulation of SAR443122 To explore the effect of a high-fat meal on the PK of the SDF formulation of SAR443122 To assess the tolerability and safety of 14-day ascending repeated oral doses of SAR443122 in healthy adult subjects	—

Measure

Time frame

To assess the tolerability and safety of SAR443122 after single ascending oral doses in healthy adult subjects. To explore relative bioavailability between study formulation (SF) and solid dosage form (SDF) formulation of SAR443122 To explore the effect of a high-fat meal on the PK of the SDF formulation of SAR443122 To assess the tolerability and safety of 14-day ascending repeated oral doses of SAR443122 in healthy adult subjects

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)