Back to resultsA First-in-human Single and Repeated Dose Escalation Study of SAR442501 in Healthy Adults Subjects
Primary Purpose
Osteochondrodysplasia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SAR442501
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Osteochondrodysplasia
Eligibility Criteria
Inclusion Criteria: Male and female participants, between 18 and 45 years of age, inclusive. Body weight between 50.0 and 85.0 kg, inclusive, body mass index between 18.0 and 32.0 kg/m2, inclusive. Certified as healthy by a comprehensive clinical assessment. Having given written informed consent prior to undertaking any study-related procedure. Exclusion Criteria: Any history or presence of clinically relevant medical status as per the protocol. Any participant who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development. The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
Sites / Locations
- Investigational site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
SAR442501
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Number of participants with adverse events/treatment-emergent adverse events/adverse events of special interest
Secondary Outcome Measures
Assessment of PK parameter: Maximum observed concentration (Cmax)
Assessment of PK parameter: First time to reach Cmax (tmax)
Assessment of PK parameter: Partial area under the serum concentration time curve (AUC)
Immunogenicity: evaluate the presence of anti-SAR442501 antibodies
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05846009
Brief Title
A First-in-human Single and Repeated Dose Escalation Study of SAR442501 in Healthy Adults Subjects
Official Title
A Phase I, First-in-human, Two-part, Randomized, Placebo-controlled, Double-blind, Single and Repeated Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Doses of SAR442501 in Healthy Adult Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 18, 2020 (Actual)
Primary Completion Date
July 13, 2021 (Actual)
Study Completion Date
July 13, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the first-in-human (FIH) study is to obtain safety, tolerability, and pharmacokinetic information on SAR442501 in a healthy adult volunteer population using an integrated single ascending dose (SAD)-multiple ascending dose (MAD) parallel cohort study design.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteochondrodysplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SAR442501
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SAR442501
Intervention Description
Subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subcutaneous injection
Primary Outcome Measure Information:
Title
Number of participants with adverse events/treatment-emergent adverse events/adverse events of special interest
Time Frame
Baseline up to end of study (EOS) (Day 89)
Secondary Outcome Measure Information:
Title
Assessment of PK parameter: Maximum observed concentration (Cmax)
Time Frame
Baseline up to EOS (Day 89)
Title
Assessment of PK parameter: First time to reach Cmax (tmax)
Time Frame
Baseline up to EOS (Day 89)
Title
Assessment of PK parameter: Partial area under the serum concentration time curve (AUC)
Time Frame
Baseline up to EOS (Day 89)
Title
Immunogenicity: evaluate the presence of anti-SAR442501 antibodies
Time Frame
Baseline up to EOS (Day 89)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male and female participants, between 18 and 45 years of age, inclusive.
Body weight between 50.0 and 85.0 kg, inclusive, body mass index between 18.0 and 32.0 kg/m2, inclusive.
Certified as healthy by a comprehensive clinical assessment.
Having given written informed consent prior to undertaking any study-related procedure.
Exclusion Criteria:
Any history or presence of clinically relevant medical status as per the protocol.
Any participant who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.
The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational site
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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
Learn more about this trial
A First-in-human Single and Repeated Dose Escalation Study of SAR442501 in Healthy Adults Subjects
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