Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Single and Repeated Doses of SAR444336 in Healthy Adult Participants

NCT05876767 | Completed Phase 1

• 1 other identifier: TDU17072-TDR17161
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

Brief Summary

This phase 1 study will assess the safety and tolerability, and characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of SAR444336 in healthy subjects following single- and repeated-dose administrations as a first step in clinical development prior to administering this new investigational medicinal product (IMP) to patients.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

• Part 1: Number of subjects with treatment-emergent adverse events (TEAEs)

  Clinical laboratory evaluations including eosinophils, procalcitonin, and c-reactive protein (CRP), Vital signs, 12-lead electrocardiogram (ECG)

  Until Day 43

• Part 2: Number of subjects with treatment-emergent adverse events (TEAEs)

  Clinical laboratory evaluations including eosinophils, procalcitonin, and c-reactive protein (CRP), Vital signs, 12-lead electrocardiogram (ECG)

  Until Day 85

Secondary Outcomes (7)

• Plasma PK parameters: Cmax

  Until Day 29 and Day 85

• Plasma PK parameters: tmax

  Until Day 29 and Day 85

• Plasma PK parameters: AUClast

  Until Day 29 and Day 85

• Plasma PK parameters: AUC

  Until Day 29 and Day 85

• Plasma PK parameters: t1/2z

  Until Day 29 and Day 85

Study Arms (2)

SAR444336

EXPERIMENTAL

SAR444336

Drug: SAR444336

Placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

SAR444336 DRUG

Single or repeated dose subcutaneous injection

SAR444336

Placebo DRUG

Single or repeated dose subcutaneous injection

Placebo

Eligibility Criteria

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

You may qualify if:

• Male and female participants between 18 and 55 years of age inclusive.
• Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG.
• Laboratory values within normal range unless the abnormality is considered not clinical relevant by the investigator. The following parameters, however, must be within normal range: platelet count, and CRP. ALT, AST, total bilirubin (unless the participant has documented or suspected Gilbert syndrome) should be \<1.25 ULN and serum creatinine should be \< ULN.
• Eosinophils \<500 cells/µL
• Normal vital signs after 10 minutes resting in supine position
• Standard 12-lead ECG parameters after 10 minutes resting in supine position in the normal ranges and normal ECG tracing unless the Investigator considers an ECG tracing abnormality to be not clinically relevant.
• Body weight between 50 - 110 kg (inclusive) and body mass index (BMI) between 18 - 30 kg/m2 (inclusive) at screening.
• Only for part 2: Fitzpatrick skin type I - III

You may not qualify if:

• Any disease associated with immune system dysfunction.
• Known polyethylene glycol allergy
• Only for Part 2: Known seafood allergy
• Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, autoimmune, systemic, ocular, or infectious disease, or signs of acute illness that would pose an unacceptable risk to the subject in the opinion of the investigator.
• Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only, more than twice a month).
• Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure ≥30 mmHg within 3 minutes when changing from supine to standing position.
• History or presence of drug or alcohol abuse.
• Smoking regularly more than 10 cigarettes or equivalent per week, unable to stop smoking during the study (occasional smoker can be enrolled).
• Excessive consumption of beverages containing xanthine bases.
• Presence or history of any atopic disease.
• for Part 1: Non-live booster COVID-19 vaccination within 14 days before randomization. First (and second, if applicable) COVID-19 vaccinations are not allowed within 4 weeks before randomization.
• for Part 2: Non-live vaccines including Covid-19: last administration of a vaccine within 4 weeks before randomization.
• Live vaccines: Last administration of a vaccine within 3 months before randomization; Immunomodulatory medication within 60 days before screening.
• Only for Part 2: Participants with known previous exposure to KLH.
• Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, antihepatitis B core antibodies (anti-HBc Ab), anti-hepatitis C virus (anti-HCV) antibodies, anti-HIV1 and anti HIV2 Ab.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (2)

Investigational Site Number :5280001

Leiden, Leiden, 2333 CL, Netherlands

Location

Investigational Site Number :5280002

Groningen, Provincie Groningen, 9728 NZ, Netherlands

Location

Related Links

• TDU17072 Plain Language Results Summary
• TDR17161 Plain Language Results Summary

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: May 25, 2023
• Study Start: October 15, 2021
• Primary Completion: December 12, 2023
• Study Completion: December 12, 2023
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

NL (2)