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

NCT05795907 | Completed Phase 1 FDA Drug

• 2 other identifiers: TDU16519-TDR16520U1111-1254-0034
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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).

Conditions

Amyotrophic Lateral Sclerosis (Healthy Volunteers)

Outcome Measures

Primary Outcomes (2)

• Parts 1a and 1b: Number of participants with adverse events

  Day1 up to Day 7 (end of study visit)

• Part 2: Number of participants with adverse events

  Day1 up to Day 21 (end of study visit)

Secondary Outcomes (10)

• Parts 1a and 1b: Assessment of pharmacokinetic parameter of SAR443820: Cmax in plasma

  Day1

• Parts 1a and 1b: Assessment of pharmacokinetic parameter of SAR443820: tmax in plasma

  Day 1

• Parts 1a and 1b : Assessment of pharmacokinetic parameter of SAR443820: AUC in plasma

  Day1

• Parts 1a and 1b : Assessment of pharmacokinetic parameter of SAR443820: t1/2z in plasma

  Day1

• Part1b: SAR443820 concentrations in cerebrospinal fluid (CSF) samples

  Day1

Study Arms (2)

SAR443820

EXPERIMENTAL

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

Drug: SAR443820

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

SAR443820 DRUG

Capsule / Oral

SAR443820

Placebo DRUG

Matching Capsule / Oral

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Positive result for hepatitis B, C or HIV
• Positive result on urine drug screen
• Positive alcohol test.
• Current psychiatric disorder, suicidal ideation in the previous 6 months (as assessed by the C-SSRS), or a lifetime suicide attempt.
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Prism Research-Site Number:8400001

Saint Paul, Minnesota, 55144, United States

Location

Related Publications (1)

• Hincelin-Mery A, Nicolas X, Cantalloube C, Pomponio R, Lewanczyk P, Benamor M, Ofengeim D, Krupka E, Hsiao-Nakamoto J, Eastenson A, Atassi N. Safety, pharmacokinetics, and target engagement of a brain penetrant RIPK1 inhibitor, SAR443820 (DNL788), in healthy adult participants. Clin Transl Sci. 2024 Jan;17(1):e13690. doi: 10.1111/cts.13690. Epub 2023 Dec 11.

  PMID: 38010108 DERIVED

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Trial Transparency email recommended (Toll free for US & Canada)

  Sanofi

  STUDY DIRECTOR

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1b with open label study design

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: April 3, 2023
• Study Start: November 30, 2020
• Primary Completion: July 20, 2021
• Study Completion: July 20, 2021
• Last Updated: April 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)