A First-in-human Single and Repeated Dose Escalation Study of SAR442501 in Healthy Adults Subjects
- Conditions
- Osteochondrodysplasia
- Registration Number
- NCT05846009
- Lead Sponsor
- Sanofi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 76
Inclusion Criteria:<br><br> - Male and female participants, between 18 and 45 years of age, inclusive.<br><br> - Body weight between 50.0 and 85.0 kg, inclusive, body mass index between 18.0 and<br> 32.0 kg/m2, inclusive.<br><br> - Certified as healthy by a comprehensive clinical assessment.<br><br> - Having given written informed consent prior to undertaking any study-related<br> procedure.<br><br>Exclusion Criteria:<br><br> - Any history or presence of clinically relevant medical status as per the protocol.<br><br> - Any participant who, in the judgment of the Investigator, is likely to be<br> noncompliant during the study, or unable to cooperate because of a language problem<br> or poor mental development.<br><br>The above information is not intended to contain all considerations relevant to the<br>potential participation in a clinical trial.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of participants with adverse events/treatment-emergent adverse events/adverse events of special interest
- Secondary Outcome Measures
Name Time Method 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