Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous and Subcutaneous Single and Repeated Doses of SAR441344 in Healthy Adult Subjects

• Sponsor: Sanofi (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05845996
• Collaborator: (none)
• Enrollment: 56
• Location: 1
• Arms: 2
• Actual Duration (Months): 13.4
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief Summary

Primary Objective is the tolerability and safety of ascending single and repeated intravenous infusion (IV) and/or subcutaneous (SC) administration of SAR441344

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: SAR441344; Drug: placebo; Biological: Keyhole limpet hemocyanin	Phase 1

Detailed Description

The study duration of Part 1 is approximately 22 weeks, including a treatment period of 1 day; The study duration of Part 2 is approximately 26 weeks for each subject, including a treatment period of 29 days.

Study Design

• Study Type: Interventional
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Parallel Design, Placebo-controlled Single and Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous and Subcutaneous Doses of SAR441344 in Healthy Adult Subjects
• Actual Study Start Date: Feb 26, 2019
• Actual Primary Completion Date: Apr 10, 2020
• Actual Study Completion Date: Apr 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SAR441344 Single or multiple Ascending dose of SAR441344 Dose 1 administered intravenously and/or subcutaneously	Drug: SAR441344; Solution for intravenous/subcutaneous injection; Biological: Keyhole limpet hemocyanin; Subcutaneous Lyophilized powder for reconstitution
Placebo Comparator: placebo matching placebo	Drug: placebo; Solution for intravenous/subcutaneous injection; Biological: Keyhole limpet hemocyanin; Subcutaneous Lyophilized powder for reconstitution

Outcome Measures

Primary Outcome Measures

1. Part 1: Number of participants with adverse event(AE) [From baseline to day 127]

   Number of participants with AE from baseline to day 127

2. Part 2: Number of participants with adverse event (AE) [From baseline to day 155]

   Number of participants with AE from baseline to day 155

Secondary Outcome Measures

1. Assessment of PK parameter: Cmax [From Day 1 to Day 127 and to Day 155]

   Maximum plasma concentration (Cmax) observed

2. Assessment of PK parameter: tmax [From Day 1 to Day 127 and Day 155]

   First time to reach Cmax (tmax)

3. Assessment of PK parameter: AUClast [From Day 1 to Day 127]

   Area under the plasma concentration versus time curve from time zero to the real time

4. Assessment of PK parameter: AUC [Area under the plasma concentration versus time curve extrapolated to infinity]

   From Day 1 to Day 127

5. Assessment of PK parameter: AUC0-tau [From day 1 to Day 155]

   Area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval (336 hours)

6. Assessment of PK parameter: Ctrough [From Day 1 to Day 155]

   Plasma concentration observed just before treatment administration during repeated dosing

7. Assessment of PK parameter: t1/2z [From Day 1 to Day 127 and Day 155]

   Terminal half-life associated with the terminal slope (λz)

8. Assessment of PK parameter: CL(/F) [Apparent total body clearance of a drug from the plasma]

   From Day 1 to Day 127

9. Assessment of PK parameter: CLss(/F) [Apparent total body clearance of a drug from the plasma]

   From day 1 to Day 155

10. Anti-SAR441344 antibodies [From Day 1 to Day 127 and Day 155]

    Number of subjects with treatment emergent anti-drug antibody formation

11. Assessment of anti-KLH IgG and IgM [From Day 1 to Day 127 and Day 155]

    Measurement of anti-KLH IgG and IgM levels in response to KLH immunization

12. AE attributed to KLH immunization [From Day 1 to Day 127 and Day 155]

    Number of participants with AE attributed to KLH immunization

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion criteria

• Having given written informed consent prior to undertaking any study-related procedure.

Exclusion criteria

• Any subject 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 a patient's potential participation in a clinical trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PPD-Site Number:8400001	Austin	Texas	United States	78744

Sponsors and Collaborators

• Sanofi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sanofi
• ClinicalTrials.gov Identifier: NCT05845996
• Other Study ID Numbers: TDU15525-TDR15526; U1111-1217-2909
• First Posted: May 6, 2023
• Last Update Posted: May 6, 2023
• Last Verified: Apr 12, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Keyhole-limpet hemocyanin

Study Results

No Results Posted as of May 6, 2023