Single & Multiple Ascending Dose Study of SAR443820 in Healthy Adult Participants
- Conditions
- Amyotrophic Lateral Sclerosis (Healthy Volunteers)
- Interventions
- Drug: Placebo
- Registration Number
- NCT05795907
- Lead Sponsor
- Sanofi
- Brief Summary
This is a Phase 1, single-center study conducted in 2 parts:
Part 1a, single ascending dose (SAD-TDU16519): Double-blind, randomized, placebo-controlled sequential ascending single oral doses including up to 6 cohorts. Each cohort will include 8 participants (6 receiving SAR443820 and 2 placebo).
Part 1b (TDU16519): - Open label, single SAR443820 dose in one or two separated cohort(s) for SAR443820 measurements in CSF and in plasma.
Part 2, multiple ascending dose (MAD -TDR16520): Double-blind, randomized, placebo-controlled, sequential ascending repeated oral doses for 14 days, including up to 4 cohorts. Each cohort will include 10 participants (8 receiving SAR443820 and 2 placebo).
- Detailed Description
The duration of the study for a participant will include:
Screening Period: up to 28 days
Part 1a:
Treatment in fasted condition: 1 day (Day 1). Study observation Period from Day -2/Day -1 to Day 3. Follow-up with the end of study: from Day 5 to Day 7. Total duration from screening per participant: up to 5 weeks.
Part 1b:
Treatment in fed condition: 1 day (Day 1). Study observation Period from Day -1/Day1 to Day 2. Follow-up with the end of study: from Day 5 to Day 7. Total duration from screening per participant: up to 5 weeks.
Part 2:
Treatment: 14 days (Day 1 to Day 14). Study observation Period from Day -2/Day -1 to Day 17. Follow-up with the end of study: from Day 19 to Day 21. Total duration from screening per participant: up to 7 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
Male and/or female participant, between 18 and 55 years of age, inclusive. Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index between 18.0 and 30.0 kg/m2, inclusive.
Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
Having given written informed consent prior to undertaking any study-related procedure.
Not under any administrative or legal supervision or under institutionalization due to regulatory or juridical order.
Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteo-muscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.
Personal medical history of seizure.
Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month).
Any medication (including St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion.
Positive result for hepatitis B, C or HIV
Positive result on urine drug screen
Positive alcohol test.
Any consumption of citrus fruits or their juices within 5 days before inclusion.
Current psychiatric disorder, suicidal ideation in the previous 6 months (as assessed by the C-SSRS), or a lifetime suicide attempt.
Additional exclusion criteria applied, and specially for Part 1b, criteria related to the study procedure of lumbar puncture.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description SAR443820 SAR443820 Single dose oral ascending dose (parts 1a and 1b) and multiple ascending oral dose (part 2) of SAR443820 Placebo Placebo Single dose oral ascending dose (part 1a) and multiple ascending oral dose (part 2) of matching placebo
- Primary Outcome Measures
Name Time Method Part 2: Number of participants with adverse events Day1 up to Day 21 (end of study visit) Parts 1a and 1b: Number of participants with adverse events Day1 up to Day 7 (end of study visit)
- Secondary Outcome Measures
Name Time Method Parts 1a and 1b: Assessment of pharmacokinetic parameter of SAR443820: Cmax in plasma Day1 Parts 1a and 1b: Maximum plasma concentration
Parts 1a and 1b: Assessment of pharmacokinetic parameter of SAR443820: tmax in plasma Day 1 Parts 1a and 1b: time to reach Cmax
Parts 1a and 1b : Assessment of pharmacokinetic parameter of SAR443820: AUC in plasma Day1 Parts 1a and 1b: Area under the plasma concentration versus time
Parts 1a and 1b : Assessment of pharmacokinetic parameter of SAR443820: t1/2z in plasma Day1 Terminal half-life in plasma
Part1b: SAR443820 concentrations in cerebrospinal fluid (CSF) samples Day1 Part 1b: CSF to plasma concentration ratio
Part 2: Assessment of pharmacokinetic parameter of SAR443820: Cmax in plasma Day1 and Day14 Part 2: Maximum plasma concentration
Part 2: Assessment of pharmacokinetic parameter of SAR443820: tmax in plasma Day1 and Day14 Part 2: Time to reach Cmax
Part 2: Assessment of pharmacokinetic parameter of SAR443820: AUC tau in plasma Day1 and Day14 Part 2: Area under the plasma concentration versus time during a dosing interval
Part 2 Assessment of pharmacokinetic parameter of SAR443820: t1/2z in plasma Day14 Terminal half-life in plasma
Part 2: Day14/Day1 of 4β-hydroxycholesterol ratio in plasma Day1 and Day14 D14/D1 of 4β-hydroxycholesterol ratio
Trial Locations
- Locations (1)
Prism Research-Site Number:8400001
🇺🇸Saint Paul, Minnesota, United States