Phase 1
N=42
Phase 1 Study of SAR440894 vs Placebo
Chikungunya Virus Infection
Bottom Line
View on ClinicalTrials.gov: NCT04441905 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Frequency of Adverse Events (AEs) — 5; 3; 2; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Placebo (Other); SAR440894 (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Adverse Events (AEs) |
5; 3; 2; 3; 2; 6 | — |
| PRIMARY Frequency of Serious Adverse Events (SAEs) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Frequency of Clinically Significant Vital Signs Results |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Frequency of Clinically Significant Chemistry Laboratory Results |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Frequency of Clinically Significant Hematology Laboratory Results |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Frequency of Clinically Significant Coagulation Laboratory Results |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Frequency of Clinically Significant Urinalysis Laboratory Results |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Frequency of Clinically Significant Electrocardiogram (ECG) Results |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Maximum Concentration (Cmax) of SAR440894 in Plasma |
7.2444; 29.1216; 91.8476; 307.1714; 466.6280 | — |
| SECONDARY Minimum Concentration (Cmin) of SAR440894 in Plasma |
1.1677; 2.9886; 5.1829; 35.3937; 59.7625 | — |
| SECONDARY Time of Maximum Concentration (Tmax) of SAR440894 in Plasma |
2.10; 2.05; 5.00; 3.65; 2.00 | — |
| SECONDARY Time of Minimum Concentration (Tmin) of SAR440894 in Plasma |
3097.0; 3542.5; 3578.0; 3530.5; 3577.0 | — |
| SECONDARY Area Under the Concentration-Time Curve From 0 h (Pre-Dose) to the Lase Concentration Above the Lower Limit of Quantitation (AUC0-last) of SAR440894 in Plasma |
5108.6; 24191.0; 68548.3; 268599.9; 437019.3 | — |
| SECONDARY Area Under the Concentration-Time Curve From 0 h (Pre-Dose) to Infinity (AUC0-inf) of SAR440894 in Plasma |
9083.8; 30661.2; 85239.6; 364777.5; 693676.5 | — |
| SECONDARY Terminal Phase Elimination Rate Constant (Lambda-z) of SAR440894 in Plasma |
0.0004111; 0.0004631; 0.0005153; 0.0003884; 0.0002922 | — |
| SECONDARY Terminal Half-Life (t1/2) of SAR440894 in Plasma |
1687.0; 1497.9; 1344.0; 1784.0; 2373.0 | — |
| SECONDARY Clearance (CL) of SAR440894 in Plasma |
0.0331; 0.0328; 0.0352; 0.0275; 0.0288 | — |
| SECONDARY Volume of Distribution (Vd) of SAR440894 in Plasma |
80.38; 70.47; 68.25; 70.55; 98.72 | — |
| SECONDARY Incidence of Anti-drug Antibody (ADA) Assay Results |
0; 0; 0; 0; 0; 0 | — |
Summary
A single, ascending-dose design with five dose-cohorts of 8 subjects. Forty healthy adults aged 18 to 45, inclusive, will be recruited and admitted at multiple sites. Each subject will be randomized to receive either SAR440894 or matching placebo via 60-minute intravenous infusion. In each cohort of 8 subjects, the randomization ratio will be 6 active to 2 placebo, and 2 sentinel subjects (one from each active and placebo group) will be dosed first. Dosing of the next dose-cohort will be dependent on acceptable meeting predefined safety criteria in the preceding cohort. Each subject's participation will take place over approximately 150 days, not including the screening visit. There are no hypotheses for this phase I study. The primary objective will be to determine the safety of single ascending intravenous (IV) infusions of SAR440894 when administered in healthy adults.
Eligibility Criteria
Inclusion Criteria
- Must be a healthy adult 18 to 45 years of age, inclusive, with a body mass index (BMI) greater than 18 or less than 35 kg/m^2, inclusive.
- Participants of childbearing potential* having vaginal intercourse must use an effective method of contraception** from 45 days before study product administration through the final study visit.
*Not sterilized via hysterectomy or bilateral oophorectomy and/or salpingectomy or be less than 1 year from the last menses if menopausal.
**Includes any of the following (a) exclusive non-male sexual relationships; (b) monogamous relationship with vasectomized partner (greater than or equal to 180 days between procedure and subject receipt of investigational product); (c) bilateral tubal ligation or tubal occlusion (eg., Essure(R)); (d) effective intrauterine device (IUD); (e) hormonal implants (eg., Implanon(R)); (f) other hormonal contraceptives (such as birth control pills, vaginal rings, patches or injections); (g) barrier methods (condom, diaphragm, cervical cap) PLUS spermicide (gel or foam)
- Women of childbearing potential must agree not to donate ova or oocytes (ie, human eggs) during the study.
- Male subjects (including those with vasectomies) whose partners are of childbearing potential should use condoms with spermicide and not donate sperm for the duration of the study.
- Must have adequate venous access for IV infusions and blood draws.
- Agrees to be available for all study visits and willing to cooperate fully with the requirements* of the study protocol.
*Requirements include remaining in confinement for at least 72 hours after receiving study product and other activities outlined in the protocol's Schedule of Events.
- Is able to understand the informed consent process and procedures and signs the consent form.
- Will agree not to donate any blood or blood products* for the duration of the study.
- Includes whole blood, red blood cells, platelets, plasma, or plasma derivatives.
- Will agree to avoid travel to endemic areas (as defined by the Center for Disease Control (CDC)) for Chikungunya Virus (CHIKV) at any point during the Follow-up period (https://www.cdc.gov/chikungunya/geo/index.html).
Exclusion Criteria
- Has any medical condition (renal dysfunction) that, in the opinion of the site PI or appropriate sub-investigator listed on Form Food and Drug Administration (FDA) 1572, is a contraindication to study participation.
- Has any clinically significant (CS) electrocardiogram (ECG) abnormalities in the opinion of the site Principal Investigator (PI) or appropriate sub-investigator been listed on Form FDA 1572.
- Use of any prohibited prescription medication (excluding contraceptives in females) within 14 days before study product administration, through Day 56** *Prohibited medications include immunosuppressives; immune modulators; oral corticosteroids (topical/intranasal steroids are acceptable); prescription Non-Steroidal Anti-inflammatory Drugs (NSAIDs); anti-neoplastic agents; any vaccine (licensed or investigational). If study activities overlap with the influenza season, subjects will be instructed to obtain influenza vaccine at least 45 days prior to proposed dosing or delay vaccination until after Day 56. Subjects will be instructed to obtain the last dose of any vaccine for SARS-CoV-2 (COVID-19) at least 45 days prior to proposed dosing or delay vaccination until after Day 56.
- Use of nonprescription systemic drugs within 7 days before study product administration (includes vitamins, antacids*, over-the-counter drugs**, herbal/dietary supplements, etc.) through Day 28***
*Nonprescription drugs and supplements may be allowed before Day 28 at the discretion of the site PI.
**Includes proton pump inhibitors and H2-blockers (Histamine-2 blockers)
***Nonprescription drugs and supplements may be allowed before Day 28 at the discretion of the site PI. In the event an OTC oral contraceptive becomes available during the course
Data sourced from ClinicalTrials.gov (NCT04441905). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.