None listed
Conditions
Brief summary
This is a parallel, randomized, placebo-controlled, two-part, Phase 1, Investigator- and participant blinded, first-in-human (FIH) study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) profiles, and immunogenicity of single (SAD17442) and multiple (MAD17443) ascending, subcutaneous doses of SAR444559 in male and female healthy participants aged 18 to 55 years. Part 1 – SAD17442: - The study duration per participant will be up to 12 weeks, including screening period. - The treatment duration will be 7 weeks including a 4-day in-house institutionalization period after single dose administration and a follow-up period up to the end of study (EOS) visit. PD is as assessed as exploratory part of the protocol. The number of visits will be 10 ambulatory on-site visits and one 4-day in-house period, and 4 to 5 ambulatory visits to the ophthalmologist. Part 2 – MAD17443: - The study duration per participant will be approximately 16 weeks, including screening period and treatment period of 11 weeks. - The treatment duration will be approximately 11 weeks including 4-day in-house institutionalization periods after each dose administration (3 total doses) and follow-up periods between and after each of the three institutionalizations up to the end of study (EOS) visit. PD is as assessed as exploratory part of the protocol. The number of visits will be 10 ambulatory on-site visits and three 4-day in-house periods, and 4 to 5 ambulatory visits to the ophthalmologist.
Interventions
Part 1:
SAR444559: Single dose administration of SAR444559 on Day 1, of approximatively 9 single ascending dose levels. The starting dose will be 0.03 mg.
Treatment duration will be 7 weeks, including a 4-day in-house institutionalisation period after single dose administration and a follow-up period up to the end of study (EOS) visit.
Mode of administration: Subcutaneous (SC) injection administered by the clinical study site staff in the clinical study center. The dose increment factors for
Part 1: SAR444559: Single dose administration of SAR444559 on Day 1, of approximatively 9 single ascending dose levels. The starting dose will be 0.03 mg. Treatment duration will be 7 weeks, including a 4-day in-house institutionalisation period after single dose administration and a follow-up period up to the end of study (EOS) visit. Mode of administration: Subcutaneous (SC) injection administered by the clinical study site staff in the clinical study center. The dose increment factors for dose escalation will be based on the observed cell depletion and may be adjusted following emerging safety and tolerability. Part 2: SAR444559: Multiple dose administrations of SAR444559 every 2 weeks (Q2W) on days 1, 15, and 29, of up to 3 ascending repeated dose levels. The starting dose of part 2 will be determined upon review of adverse event, PK and PD data from Part 1 by a safety review committee. The dose increment factors for dose escalation will be based on the observed cell depletion and may be adjusted following emerging safety, tolerability. Treatment duration will be approximately 11 weeks including 4-day in-house institutionalisation periods after each dose administration (3 total doses) and follow-up periods between and after each of the three institutionalizations up to the end of study (EOS) visit. Mode of administration: SC injections administered by the clinical study site staff in the clinical study centre. Participants in part 1 and part 2 are recruited independently, and part 2 will be undertaken in unique participant cohorts. The strategies used to monitor adherence to and/or fidelity of the intervention will include supervised administration at site, appropriate record of each administration information, and double confirmation of the dosing by another member of the study site staff other than the one administrating the study intervention.
Sponsors
Sanofi-Aventis Australia Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Participants who are overtly healthy as determined by medical evaluation including medical/surgical history, physical examination, laboratory tests, and cardiac monitoring. Body weight within 50 to 100 kg and body mass index (BMI) within the range 18 to 32 kg/m2 (inclusive). A female participant not pregnant or breastfeeding, and one of the following conditions applies: -- Is a woman of non-child-bearing potential (WONCBP) or -- Is a woman of child-bearing potential (WOCBP) and agrees to use a contraceptive method that is highly effective Male participants who agree to refrain from donating and cryopreservating sperm
Exclusion criteria
Participants are excluded from the study if any of the following criteria apply: -History or presence of cardiovascular, respiratory (excluding fully resolved childhood asthma with no history of hospitalization), hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data. - Significant ocular disease including but not limited to any history of glaucoma, any retinal pathology or history of retinal issues including retinal tears/holes/detachment, history of ocular inflammation/uveitis, moderate/severe refractive errors, pathologic gonioscopy result, and shallow anterior chamber. -Live vaccines: Last administration of a vaccine within 3 months before randomization.
Outcome results
None listed