Chikungunya Virus InfectionPhase 1NCT04441905
Phase 1 Study of SAR440894 vs Placebo
A Phase 1 study testing SAR440894 in people with Chikungunya Virus Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Chikungunya Virus Infection
- What is being tested?
- SAR440894
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Oct 2020to 22 Aug 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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)
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- 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 of the study, it must be reviewed and approved by the site PI.
- Hypertension, with confirmed systolic blood pressure (BP) greater than 140 mm Hg or confirmed diastolic BP greater than 90 mm Hg, measured after 5 minutes of rest at Screening.
- Hypotension, with confirmed systolic BP less than 90 mm Hg.
- Resting heart rate (HR) less than 45 bpm or greater than 100 bpm at Screening.
- Body weight less than 50 kg.
- History of a significant illness, per the investigators' clinical judgment, within 2 weeks before dosing (subjects can screen after illness is resolved for 2 weeks).
- Known diagnosis of prolonged QT interval, congenital long QT syndrome, bradyarrhythmias, or uncompensated heart failure.
- Males with a mean QTcF greater than 450 msec or females with a mean QTcF greater than 470 msec (Fridericia's correction) at Screening.*
- ECG tracings should be recorded at least 1 minute apart, after at least 5 minutes of rest in the supine position. If the mean QTcF value from the 3 tracings exceeds the limits stated, the subject is disqualified.
- Any history of malignancy ever, except low-grade skin cancer (ie, basal cell carcinoma thought to be cured).
- History of drug abuse, alcohol abuse, or significant psychiatric history according to the investigators' judgment within 12 months before Screening.
- Positive for hepatitis B virus surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) antibody at Screening.
- Excessive consumption of beverages containing xanthine bases, or more than 400 mg of caffeine per day within 1 week of study product administration through the final study visit.
- Consumption of alcohol within 24 hours before study product administration.
- Use of nicotine-containing products within 45 days before study product administration through the final study visit.
- Positive drug screen*, positive cotinine screen, or positive breathalyzer test for alcohol at Screening or admission (Day -1).
- Cannabinoids, amphetamines, barbiturates, cocaine, opiates, benzodiazepines and phencyclidine. Subjects should be notified by phone not to consume any poppy seeds within 24 hours before the Screening urine test to avoid a false positive opioid test result.
- If female, serum positive pregnancy test at Screening or serum positive pregnancy test on Day -1.
- Breastfeeding throughout the duration of the study
- Total WBC and platelet counts, hemoglobin*, total bilirubin*, alanine/aspartate aminotransferase* and sodium* are Grade 1 or higher at Screening visit*.
- For sodium; potential subjects excluded prior to Protocol Version 6.0 with Grade 1 sodium values may be rescreened.
- For hemoglobin; a lower limit within 0.5 g/dL of the lower limit of normal (LLN) is allowable at Screening.
- For total bilirubin; ULN values will be allowed at Screening and Day -1/baseline provided the AST and ALT are within normal limits. Potential subjects excluded prior to Protocol Version 6.0 with bilirubin values below the Version 6.0 upper limit may be rescreened.
- For ALT/AST; subjects who screened prior to Protocol Version 11.0 were excluded if AST/ALT results were Grade 1 or higher at Screening. Subjects who screen with Protocol Version 11.0, AST/ALT is exclusionary if Screening results are 1.5 × ULN or if assessed as CS by the site PI.
- Grade 1 or higher toxicity, see Appendix C and Appendix D for subjects who screened and enrolled prior to Protocol Version 11.0. Subjects who screen and enroll with Protocol Version 11.0, toxicity will be assessed with the NCI CTCAE, Version 5.0 - November 2017. Safety laboratory tests drawn on Day -1 or Screening if within 48 hours of planned dosing will serve as baseline values. Day -1 laboratory tests with a Grade 1 severity, other than those noted above, will not exclude subjects from participation.
- All other abnormal laboratory values collected at Screening and on Day -1 will be exclusionary at the discretion of the PI.
- Potassium, bicarbonate or creatinine/eGFR* results are Grade 1 or higher at either Screening or Day -1/Baseline visits.
- For creatinine; subjects who screened prior to Protocol Version 11.0 were excluded if creatinine results were Grade 1 or higher. Subjects who screen with Protocol Version 11.0, creatinine is not an exclusionary criterion, instead subjects should have a calculated eGFR using Chronic Kidney Disease Epidemiology Collaboration Creatinine Equation (CKD-EPI) of >/= 90 mL/min/1.73m2 to be enrolled in the study.
- Received an experimental agent (vaccine, drug, biologic, device, or medication) within 45 days or 5 half-lives (whichever is longer) before study product administration.*
- Prior participation at any time in noninvasive methodology trials in which no drugs were given is acceptable.
- Is participating in or plans to participate in another clinical trial with an interventional agent that will be received during this trial.
- Has donated more than 500 mL of blood or blood products* within the month before Screening.
- Includes whole blood, red blood cells, platelets, plasma, or plasma derivatives.
- Has a history of serologically-proven Chikungunya virus (CHIKV) exposure at any point, or positive anti CHIKV antibodies (ie., positive IgM or IgG) at Screening.
- Has received blood products within 120 days prior to Screening.
- Has received mAb in the past 3-months or 5 half-lives (whichever is longer) prior to Screening, whether licensed or investigational, or plans to receive a mAb outside of this study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
PPD - Austin Clinical Research Unit
Austin, Texas, 78744-1645
Duke University School of Medicine - Duke Clinical Research Institute - Duke Clinical Research Unit
Durham, North Carolina, 27710
Pharmaceutical Product Development - Orlando Clinical Research Unit
Orlando, Florida, 32806
About this study
Official title: A Phase 1, Randomized, Double-Blind, Multi-Site, Single Dose Escalation Study to Evaluate the Safety, Pharmacokinetics, and Immunogenicity of SAR440894 vs Placebo in Healthy Adults
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.
Read the detailed description
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. The secondary objectives are: 1) to determine the pharmacokinetics (PK) of single ascending doses of 60-minute IV infusions SAR440894 in healthy adults and 2) to asses the immunogenicity of single ascending doses of 60-minute IV infusions SAR440894 in healthy adults.
- Conditions
- Chikungunya Virus Infection
- Being tested
- Placebo, SAR440894
- Keywords
- Chikungunya Virus, dose escalation, healthy adults, Immunogenicity, Pharmacokinetics, phase 1, placebo, SAR440894
- Medical subject headings
- Chikungunya Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
One time 60-minute IV infusion of lyophilized placebo for SAR440894
SAR440894Biological
One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 0.3 mg/kg of SAR440894 (n=6) or placebo (n=2) administered once during a 60-minute intravenous (IV) infusion. 2 sentinel subjects will receive dosing for review of safety data (SAR440894 n=1, placebo n=1) before remainder of cohort. Receives: Other: Placebo; Biological: SAR440894 |
| Cohort 2 | Experimental | 1 mg/kg of SAR440894 (n=6) or placebo (n=2) administered once during a 60-minute intravenous (IV) infusion. 2 sentinel subjects will receive dosing for review of safety data (SAR440894 n=1, placebo n=1) before remainder of cohort. Receives: Other: Placebo; Biological: SAR440894 |
| Cohort 3 | Experimental | 3 mg/kg of SAR440894 (n=6) or placebo (n=2) administered once during a 60-minute intravenous (IV) infusion. 2 sentinel subjects will receive dosing for review of safety data (SAR440894 n=1, placebo n=1) before remainder of cohort. Receives: Other: Placebo; Biological: SAR440894 |
| Cohort 4 | Experimental | 10 mg/kg of SAR440894 (n=6) or placebo (n=2) administered once during a 60-minute intravenous (IV) infusion. 2 sentinel subjects will receive dosing for review of safety data (SAR440894 n=1, placebo n=1) before remainder of cohort. Receives: Other: Placebo; Biological: SAR440894 |
| Cohort 5 | Experimental | 20 mg/kg of SAR440894 (n=6) or placebo (n=2) administered once during a 60-minute intravenous (IV) infusion. 2 sentinel subjects will receive dosing for review of safety data (SAR440894 n=1, placebo n=1) before remainder of cohort. Receives: Other: Placebo; Biological: SAR440894 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Adverse Events (AEs)
The number of participants who experienced at least one unsolicited AE. An AE is defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of medicinal (investigational) product. Any medical condition that was present at screening was considered a baseline finding and not reported as an AE. However, if the severity (i.e., grade) of any pre-existing medical condition increases, it was recorded as an AE. For participants who enrolled prior to protocol v11.0, AEs were assessed with protocol defined criteria. For participants who enrolled under protocol v11.0, AEs were assessed with NCI CTCAE, Version 5.0.
Measured: Day 1 through Day 150
Frequency of Serious Adverse Events (SAEs)
The number of participants who experienced at least one SAE throughout the course of the study. An AE is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes:
- Death
- A life-threatening adverse event
- Inpatient hospitalization or prolongation of existing hospitalization
- A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or
- A congenital anomaly/birth defect.
Measured: Day 1 through Day 150
Frequency of Clinically Significant Vital Signs Results
The number of participants who experienced at least one clinically significant vital signs abnormality post-dosing is summarized by parameter. Clinical significance was determined by the site investigator for all results that met toxicity grading criteria. For participants who enrolled prior to protocol v11.0, vital signs results were graded according to protocol-defined toxicity criteria. For participant who enrolled under protocol v11.0, vital signs results were graded according to the NCI CTCAE, Version 5.0.
Measured: Day 1 through Day 150
Frequency of Clinically Significant Chemistry Laboratory Results
The number of participants who experienced at least one clinically significant chemistry laboratory abnormality post-dosing is summarized by parameter. Clinical significance was determined by the site investigator for all results that were outside the normal range. For participants who enrolled prior to protocol v11.0, laboratory results were graded according to protocol-defined toxicity criteria. For participants who enrolled under protocol v11.0, laboratory results were graded according to the NCI CTCAE, Version 5.0.
Measured: Day 1 through Day 150
Frequency of Clinically Significant Hematology Laboratory Results
The number of participants who experienced at least one clinically significant hematology laboratory abnormality post-dosing is summarized by parameter. Clinical significance was determined by the site investigator for all results that were outside the normal range. For participants who enrolled prior to protocol v11.0, laboratory results were graded according to protocol-defined toxicity criteria. For participants who enrolled under protocol v11.0, laboratory results were graded according to the NCI CTCAE, Version 5.0.
Measured: Day 1 through Day 150
Frequency of Clinically Significant Coagulation Laboratory Results
The number of participants who experienced at least one clinically significant coagulation laboratory abnormality post-dosing is summarized by parameter. Clinical significance was determined by the site investigator for all results that were outside the normal range. For participants who enrolled prior to protocol v11.0, laboratory results were graded according to protocol-defined toxicity criteria. For participants who enrolled under protocol v11.0, laboratory results were graded according to the NCI CTCAE, Version 5.0.
Measured: Day 1 through Day 150
Frequency of Clinically Significant Urinalysis Laboratory Results
The number of participants who experienced at least one clinically significant urinalysis laboratory abnormality post-dosing is summarized by parameter. Clinical significance was determined by the site investigator for all results that were outside the normal range. For participants who enrolled prior to protocol v11.0, laboratory results were graded according to protocol-defined toxicity criteria. For participants who enrolled under protocol v11.0, laboratory results were graded according to the NCI CTCAE, Version 5.0.
Measured: Day 1 through Day 150
Frequency of Clinically Significant Electrocardiogram (ECG) Results
The number of participants who experienced at least one clinically significant ECG result post-dosing. Clinical significance was determined by the site investigator.
Measured: Day 1 through Day 150
Secondary outcomes (11)
Maximum Concentration (Cmax) of SAR440894 in Plasma
PK parameters were estimated from the SAR440894 plasma concentration-time data after a complete dose using Phoenix WinNonlin Non-compartmental analysis.
Measured: Day 1 through Day 150
Minimum Concentration (Cmin) of SAR440894 in Plasma
PK parameters were estimated from the SAR440894 plasma concentration-time data after a complete dose using Phoenix WinNonlin Non-compartmental analysis.
Measured: Day 1 through Day 150
Time of Maximum Concentration (Tmax) of SAR440894 in Plasma
PK parameters were estimated from the SAR440894 plasma concentration-time data after a complete dose using Phoenix WinNonlin Non-compartmental analysis.
Measured: Day 1 through Day 150
Time of Minimum Concentration (Tmin) of SAR440894 in Plasma
PK parameters were estimated from the SAR440894 plasma concentration-time data after a complete dose using Phoenix WinNonlin Non-compartmental analysis.
Measured: Day 1 through Day 150
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
PK parameters were estimated from the SAR440894 plasma concentration-time data after a complete dose using Phoenix WinNonlin Non-compartmental analysis.
Measured: Day 1 through Day 150
Area Under the Concentration-Time Curve From 0 h (Pre-Dose) to Infinity (AUC0-inf) of SAR440894 in Plasma
PK parameters were estimated from the SAR440894 plasma concentration-time data after a complete dose using Phoenix WinNonlin Non-compartmental analysis. AUC0-inf was estimated for parameters meeting the following lambda-z acceptance criteria: rsq_adjusted (adjusted r squared) >= 0.90 and includes at least 3 time points after Tmax.
Measured: Day 1 through Day 150
Terminal Phase Elimination Rate Constant (Lambda-z) of SAR440894 in Plasma
PK parameters were estimated from the SAR440894 plasma concentration-time data after a complete dose using Phoenix WinNonlin Non-compartmental analysis. AUC0-inf was estimated for parameters meeting the following lambda-z acceptance criteria: rsq_adjusted (adjusted r squared) >= 0.90 and includes at least 3 time points after Tmax.
Measured: Day 1 through Day 150
Terminal Half-Life (t1/2) of SAR440894 in Plasma
PK parameters were estimated from the SAR440894 plasma concentration-time data after a complete dose using Phoenix WinNonlin Non-compartmental analysis. AUC0-inf was estimated for parameters meeting the following lambda-z acceptance criteria: rsq_adjusted (adjusted r squared) >= 0.90 and includes at least 3 time points after Tmax.
Measured: Day 1 through Day 150
Clearance (CL) of SAR440894 in Plasma
PK parameters were estimated from the SAR440894 plasma concentration-time data after a complete dose using Phoenix WinNonlin Non-compartmental analysis. AUC0-inf was estimated for parameters meeting the following lambda-z acceptance criteria: rsq_adjusted (adjusted r squared) >= 0.90 and includes at least 3 time points after Tmax.
Measured: Day 1 through Day 150
Volume of Distribution (Vd) of SAR440894 in Plasma
PK parameters were estimated from the SAR440894 plasma concentration-time data after a complete dose using Phoenix WinNonlin Non-compartmental analysis. AUC0-inf was estimated for parameters meeting the following lambda-z acceptance criteria: rsq_adjusted (adjusted r squared) >= 0.90 and includes at least 3 time points after Tmax.
Measured: Day 1 through Day 150
Incidence of Anti-drug Antibody (ADA) Assay Results
Incidence of ADA is defined as either treatment-induced or treatment-boosted ADA at any time point post dosing. For immunogenicity assays, a positive result is defined as a positive screening assay followed by a positive confirmation assay. Treatment-induced ADA is defined as a negative result at baseline and a positive result post-dose. Treatment-boosted ADA is defined as a positive result at both baseline and post-dose, with a 4-fold increase in titer.
Measured: Day 1 through Day 150
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start14 Oct 2020
- Primary completion22 Aug 2024
- Study completion22 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chikungunya Virus InfectionStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04441905
- Sponsor's protocol ID
- 18-0006
- Status last verified
- 11 Sep 2025
- First submitted
- 19 Jun 2020
- Last updated
- 13 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Multi-Site, Single Dose Escalation Study to Evaluate the Safety, Pharmacokinetics, and Immunogenicity of SAR440894 vs Placebo in Healthy Adults
- ClinicalTrials.gov ID
- NCT04441905
- Acronym / sponsor ID
- 18-0006
- Conditions
- Chikungunya Virus Infection
- Keywords
- Chikungunya Virus, dose escalation, healthy adults, Immunogenicity, Pharmacokinetics, phase 1, placebo, SAR440894
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- 22 Aug 2024 (actual)
- Study completion
- 22 Aug 2024 (actual)
- First posted
- 22 Jun 2020 (actual)
- Results
- Posted 26 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. The secondary objectives are: 1) to determine the pharmacokinetics (PK) of single ascending doses of 60-minute IV infusions SAR440894 in healthy adults and 2) to asses the immunogenicity of single ascending doses of 60-minute IV infusions SAR440894 in healthy adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Other: Placebo, Biological: SAR4408940.3 mg/kg of SAR440894 (n=6) or placebo (n=2) administered once during a 60-minute intravenous (IV) infusion. 2 sentinel subjects will receive dosing for review of safety data (SAR440894 n=1, placebo n=1) before remainder of cohort. |
| Cohort 2 | Experimental | Other: Placebo, Biological: SAR4408941 mg/kg of SAR440894 (n=6) or placebo (n=2) administered once during a 60-minute intravenous (IV) infusion. 2 sentinel subjects will receive dosing for review of safety data (SAR440894 n=1, placebo n=1) before remainder of cohort. |
| Cohort 3 | Experimental | Other: Placebo, Biological: SAR4408943 mg/kg of SAR440894 (n=6) or placebo (n=2) administered once during a 60-minute intravenous (IV) infusion. 2 sentinel subjects will receive dosing for review of safety data (SAR440894 n=1, placebo n=1) before remainder of cohort. |
| Cohort 4 | Experimental | Other: Placebo, Biological: SAR44089410 mg/kg of SAR440894 (n=6) or placebo (n=2) administered once during a 60-minute intravenous (IV) infusion. 2 sentinel subjects will receive dosing for review of safety data (SAR440894 n=1, placebo n=1) before remainder of cohort. |
| Cohort 5 | Experimental | Other: Placebo, Biological: SAR44089420 mg/kg of SAR440894 (n=6) or placebo (n=2) administered once during a 60-minute intravenous (IV) infusion. 2 sentinel subjects will receive dosing for review of safety data (SAR440894 n=1, placebo n=1) before remainder of cohort. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (42 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboOne time 60-minute IV infusion of lyophilized placebo for SAR440894 | Other | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
| SAR440894One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus | Biological | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
Primary outcome
Frequency of Adverse Events (AEs)
Time frame: Day 1 through Day 150
The number of participants who experienced at least one unsolicited AE. An AE is defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of medicinal (investigational) product. Any medical condition that was present at screening was considered a baseline finding and not reported as an AE. However, if the severity (i.e., grade) of any pre-existing medical condition increases, it was recorded as an AE. For participants who enrolled prior to protocol v11.0, AEs were assessed with protocol defined criteria. For participants who enrolled under protocol v11.0, AEs were assessed with NCI CTCAE, Version 5.0.
Frequency of Serious Adverse Events (SAEs)
Time frame: Day 1 through Day 150
The number of participants who experienced at least one SAE throughout the course of the study. An AE is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening adverse event * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or * A congenital anomaly/birth defect.
Frequency of Clinically Significant Vital Signs Results
Time frame: Day 1 through Day 150
The number of participants who experienced at least one clinically significant vital signs abnormality post-dosing is summarized by parameter. Clinical significance was determined by the site investigator for all results that met toxicity grading criteria. For participants who enrolled prior to protocol v11.0, vital signs results were graded according to protocol-defined toxicity criteria. For participant who enrolled under protocol v11.0, vital signs results were graded according to the NCI CTCAE, Version 5.0.
Frequency of Clinically Significant Chemistry Laboratory Results
Time frame: Day 1 through Day 150
The number of participants who experienced at least one clinically significant chemistry laboratory abnormality post-dosing is summarized by parameter. Clinical significance was determined by the site investigator for all results that were outside the normal range. For participants who enrolled prior to protocol v11.0, laboratory results were graded according to protocol-defined toxicity criteria. For participants who enrolled under protocol v11.0, laboratory results were graded according to the NCI CTCAE, Version 5.0.
Frequency of Clinically Significant Hematology Laboratory Results
Time frame: Day 1 through Day 150
The number of participants who experienced at least one clinically significant hematology laboratory abnormality post-dosing is summarized by parameter. Clinical significance was determined by the site investigator for all results that were outside the normal range. For participants who enrolled prior to protocol v11.0, laboratory results were graded according to protocol-defined toxicity criteria. For participants who enrolled under protocol v11.0, laboratory results were graded according to the NCI CTCAE, Version 5.0.
Frequency of Clinically Significant Coagulation Laboratory Results
Time frame: Day 1 through Day 150
The number of participants who experienced at least one clinically significant coagulation laboratory abnormality post-dosing is summarized by parameter. Clinical significance was determined by the site investigator for all results that were outside the normal range. For participants who enrolled prior to protocol v11.0, laboratory results were graded according to protocol-defined toxicity criteria. For participants who enrolled under protocol v11.0, laboratory results were graded according to the NCI CTCAE, Version 5.0.
Frequency of Clinically Significant Urinalysis Laboratory Results
Time frame: Day 1 through Day 150
The number of participants who experienced at least one clinically significant urinalysis laboratory abnormality post-dosing is summarized by parameter. Clinical significance was determined by the site investigator for all results that were outside the normal range. For participants who enrolled prior to protocol v11.0, laboratory results were graded according to protocol-defined toxicity criteria. For participants who enrolled under protocol v11.0, laboratory results were graded according to the NCI CTCAE, Version 5.0.
Frequency of Clinically Significant Electrocardiogram (ECG) Results
Time frame: Day 1 through Day 150
The number of participants who experienced at least one clinically significant ECG result post-dosing. Clinical significance was determined by the site investigator.
11 secondary outcomes
Maximum Concentration (Cmax) of SAR440894 in Plasma
Time frame: Day 1 through Day 150
Minimum Concentration (Cmin) of SAR440894 in Plasma
Time frame: Day 1 through Day 150
Time of Maximum Concentration (Tmax) of SAR440894 in Plasma
Time frame: Day 1 through Day 150
Time of Minimum Concentration (Tmin) of SAR440894 in Plasma
Time frame: Day 1 through Day 150
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
Time frame: Day 1 through Day 150
Area Under the Concentration-Time Curve From 0 h (Pre-Dose) to Infinity (AUC0-inf) of SAR440894 in Plasma
Time frame: Day 1 through Day 150
Terminal Phase Elimination Rate Constant (Lambda-z) of SAR440894 in Plasma
Time frame: Day 1 through Day 150
Terminal Half-Life (t1/2) of SAR440894 in Plasma
Time frame: Day 1 through Day 150
Clearance (CL) of SAR440894 in Plasma
Time frame: Day 1 through Day 150
Volume of Distribution (Vd) of SAR440894 in Plasma
Time frame: Day 1 through Day 150
Incidence of Anti-drug Antibody (ADA) Assay Results
Time frame: Day 1 through Day 150
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SAR440894 in people with Chikungunya Virus Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Adverse Events (AEs) (time frame: Day 1 through Day 150). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.