Phase 1 N=36 Randomized Triple-blind Treatment

Phase 1, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of an Enterovirus D68-specific Monoclonal Antibody in Healthy Adults

Enterovirus Infection

Bottom Line

View on ClinicalTrials.gov: NCT06444048 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2026

Primary outcome: Primary: Number of Participants Experiencing Solicited Adverse Events (AEs) Through 48 Hours Post-infusion — 7; 4; 3; 3 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: EV68-228-N (Biological); Placebo for EV68-228-N (Other)
Age: Adult · 18+ yrs
Sex: All
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Primary completion: Apr 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Experiencing Solicited Adverse Events (AEs) Through 48 Hours Post-infusion	7; 4; 3; 3	—
PRIMARY Number of Participants Experiencing Unsolicited AEs - Including Clinical and Laboratory AEs - Through Day 29	2; 5; 3; 3	—
PRIMARY Number of Participants Experiencing Unsolicited Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and New Onset Chronic Medical Conditions (NOCMCs) Through the End of the Study	0; 0; 0; 0; 0; 0	—
SECONDARY Area Under the Concentration-time Curve From Time 0 (Time of Infusion Start, t=0 Hours) to the Last Quantifiable Concentration (AUC0-last) of EV68-228-N in Serum	20800; 86590; 245200	—
SECONDARY Area Under the Concentration-time Curve From Time 0 (Time of Infusion Start, t=0 Hours) to Infinity (AUC0-infinity) of EV68-228-N in Serum	21600; 88850; 251700	—
SECONDARY Area Under the Concentration-time Curve From Time 0 (Time of Infusion Start, t=0 Hours) to 48 Hours Post-dose (AUC0-48) of EV68-228-N in Serum	2435; 9966; 29440	—
SECONDARY Maximum Observed Serum Concentration (Cmax) of EV68-228-N in Serum	76.21; 313.8; 937.7	—
SECONDARY Time of Maximum Observed Serum Concentration (Tmax) of EV68-228-N in Serum	1.35; 1.5; 3.5	—
SECONDARY Apparent Terminal Elimination Half-life (t1/2) of EV68-228-N in Serum	601.75; 588.42; 611.52	—
SECONDARY Total Clearance (CL) of EV68-228-N in Serum	0.139; 0.112; 0.120	—
SECONDARY Volume of Distribution (Vz) of EV68-228-N in Serum During the Terminal Phase	120.61; 95.48; 105.18	—
SECONDARY Number of Participants With Detectable Anti-EV68-228-N Antibodies in Serum	0; 2; 1; 0	—

Summary

This is a Phase 1, randomized, placebo-controlled, double-blinded study to assess the safety and pharmacokinetics of single IV administrations of EV68-228-N in healthy adult volunteers. Three doses (3, 10 and 30 mg/kg) of EV68-228-N will be evaluated in three separate, sequential cohorts in this single dose escalation study. The cohorts will be randomized in a 5:1 randomization scheme. The first two participants in each cohort will serve as sentinels. Sentinel participants may be located at different sites. Sentinel safety data will be collected through Day 3 before submitting to the Protocol Safety Review Team (PSRT) for review. The PSRT is comprised of the Principal Investigator (PI), the DMID Medical Monitor, and the DMID Medical Officer. Data to be reviewed will include clinical data collected from Visits 1, 2 and 3, the results of laboratory testing conducted at these visits, solicited adverse events (AEs) and the passive reporting of adverse events through Day 3. From the time of infusion of the sentinels to at least 48 hours after infusion, no new participants will be given study product or placebo, but screening may continue. If no safety signal is detected in the sentinel group, and after approval from the DMID Medical Monitor, the remaining 10 participants in the cohort will be dosed following the overall 5:1 randomization scheme. All participants will be actively monitored for AEs and safety laboratory data following dosing through Day 8. Data will be reviewed by the PSRT and discussed with the Safety Monitoring Committee (SMC) for their concurrence before advancing to the next cohort. Electronic review of the safety data by the SMC is required prior to the cohort dose escalation when halting rules are met or there are any safety concerns. The primary objective is to evaluate the safety of a single IV infusion of either 3, 10, or 30 mg/kg of EV68-228-N when administered to healthy adults.

Eligibility Criteria

Inclusion Criteria

Provides written informed consent prior to initiation of any study procedures.
Is able to understand and agrees to adhere to planned study procedures and is available for all study visits.
Adult volunteers 18 to 49 years of age, inclusive.
Females who are of childbearing potential must agree not to become pregnant. Not of childbearing potential includes post-menopausal females (defined as no menses for at least 12 months without an alternative medical cause for amenorrhea) or surgically sterile females with documented history of hysterectomy, bilateral oophorectomy, tubal ligation/salpingectomy, or Essure(R) placement.
Females who have sexual intercourse with male partners must agree to use at least one acceptable form of contraception for the duration of the study.

Acceptable methods of birth control include long-acting reversible contraception (LARC), combined pill, progestin-only pill, hormone-releasing transdermal patch or vaginal ring, and depot medroxyprogesterone acetate (DMPA) injection. Participants who choose to use a licensed hormonal product should use them for a minimum of 28 days prior to study infusion. True sexual abstinence or a monogamous relationship with a vasectomized partner who has been vasectomized for 180 days or more prior to the participant's first infusion are also acceptable contraceptive methods.

Participants who report practicing true abstinence, defined as no heterosexual vaginal-penile intercourse, need to practice true abstinence at all times during the study. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and the withdrawal method are not acceptable methods of contraception.

Females of childbearing potential must agree to not donate ova or oocytes during the study.
Participant is in good health Good health is defined by the absence of a medical condition described in the exclusion criteria. If the participant has another current, ongoing medical condition, the condition cannot meet any of the following criteria: (1) was first diagnosed within 3 months of enrollment with a clinically significant condition, in the opinion of investigator that has worsened within 3 months of enrollment; (2) had non-elective surgery, clinically significant medical procedure, or hospitalization within 3 months of enrollment; (3) received new prescription for systemic medication within 30 days of enrollment, unless the new prescription is in the same class of agent or a transition from generic to/from brand name equivalent; or (4) takes medication that may pose a risk to participant's safety or impede assessment of adverse events or study endpoints if they participate in the study.
Must agree to refrain from donating blood or blood products during the study. This includes whole blood cells, red blood cells, platelets, plasma, and plasma derivatives collected and donated outside of the study blood draws.
Body mass index (BMI) 18 kg/m2 to 32 kg/m2, inclusive, and a weight of 125 kg or less at time of screening.
Must have adequate venous access for intravenous (IV) infusion and blood sampling.

Exclusion Criteria

All participants meeting any of the exclusion criteria at baseline will be excluded from study participation.

Positive pregnancy test at screening or prior to infusion.
Female participant who is lactating.
Presence of significant psychiatric condition, that in the opinion of the site PI or appropriate sub-investigator, precludes study participation.
History of drug abuse or alcohol abuse within 6 months of enrollment that, in the opinion of the site PI or appropriate sub-investigator, precludes study participation.
Has a significant acute illness (with or without fever), as determined by the site PI or appropriate sub-investigator, within 72 hours prior to infusion.

If the participant meets all other eligibility criteria, they may be enrolled and dosed once they meet this eligibility criterion. If

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Data sourced from ClinicalTrials.gov (NCT06444048). 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.