Single & Multiple Ascending Dose Study of SAR443820 in Healthy Adult Participants

Sanofi

Status and phase: Completed; Phase 1

Conditions: Amyotrophic Lateral Sclerosis (Healthy Volunteers)

Treatments: Drug: SAR443820; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05795907

TDU16519-TDR16520

U1111-1254-0034 (Registry Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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84 participants in 2 patient groups, including a placebo group

SAR443820

Experimental group

Description:

Single dose oral ascending dose (parts 1a and 1b) and multiple ascending oral dose (part 2) of SAR443820

Treatment:

Drug: SAR443820

Placebo

Placebo Comparator group

Description:

Single dose oral ascending dose (part 1a) and multiple ascending oral dose (part 2) of matching placebo

Treatment:

Drug: Placebo