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Amyotrophic Lateral Sclerosis (Healthy Volunteers)Phase 1NCT05795907

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

A Phase 1 study testing SAR443820 in people with Amyotrophic Lateral Sclerosis (Healthy Volunteers), run by Sanofi at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
What is being tested?
SAR443820
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
84 participants
Where
1 siteUnited States
Study dates
30 Nov 2020to 20 Jul 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 11Show fewer
  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Prism Research-Site Number:8400001

    Saint Paul, Minnesota, 55144

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability and Pharmacokinetics of Ascending Single and 14-day Repeated Oral Doses of SAR443820 in Healthy Adult Participants.

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).

Read the 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.

Being tested
SAR443820, Placebo
Medical subject headings
Amyotrophic Lateral Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SAR443820Drug

    Capsule / Oral

  • PlaceboDrug

    Matching Capsule / Oral

Study groups in NCT05795907
Study groupRoleWhat they receive
SAR443820ExperimentalSingle dose oral ascending dose (parts 1a and 1b) and multiple ascending oral dose (part 2) of SAR443820
Receives: Drug: SAR443820
PlaceboPlacebo comparatorSingle dose oral ascending dose (part 1a) and multiple ascending oral dose (part 2) of matching placebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Day1 up to Day 7 (end of study visit)

  2. Part 2: Number of participants with adverse events

    Measured: Day1 up to Day 21 (end of study visit)

Secondary outcomes (10)

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

    Parts 1a and 1b: Maximum plasma concentration

    Measured: Day1

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

    Parts 1a and 1b: time to reach Cmax

    Measured: Day 1

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

    Parts 1a and 1b: Area under the plasma concentration versus time

    Measured: Day1

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

    Terminal half-life in plasma

    Measured: Day1

  5. Part1b: SAR443820 concentrations in cerebrospinal fluid (CSF) samples

    Part 1b: CSF to plasma concentration ratio

    Measured: Day1

  6. Part 2: Assessment of pharmacokinetic parameter of SAR443820: Cmax in plasma

    Part 2: Maximum plasma concentration

    Measured: Day1 and Day14

  7. Part 2: Assessment of pharmacokinetic parameter of SAR443820: tmax in plasma

    Part 2: Time to reach Cmax

    Measured: Day1 and Day14

  8. Part 2: Assessment of pharmacokinetic parameter of SAR443820: AUC tau in plasma

    Part 2: Area under the plasma concentration versus time during a dosing interval

    Measured: Day1 and Day14

  9. Part 2 Assessment of pharmacokinetic parameter of SAR443820: t1/2z in plasma

    Terminal half-life in plasma

    Measured: Day14

  10. Part 2: Day14/Day1 of 4β-hydroxycholesterol ratio in plasma

    D14/D1 of 4β-hydroxycholesterol ratio

    Measured: Day1 and Day14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2023
  2. Study start30 Nov 2020
  3. Primary completion20 Jul 2021
  4. Study completion20 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Part 1b with open label study design
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05795907
Sponsor's protocol ID
TDU16519-TDR16520
Other IDs
U1111-1254-0034
Status last verified
Mar 2023
First submitted
8 Mar 2023
Last updated
3 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Publications

  • 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.

    PubMed 38010108

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SAR443820 in people with Amyotrophic Lateral Sclerosis (Healthy Volunteers), run by Sanofi at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Parts 1a and 1b: Number of participants with adverse events (time frame: Day1 up to Day 7 (end of study visit)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05795907, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.

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