Phase 1, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Tolerabili… (NCT06444048) | Clinical Trial Compass
CompletedPhase 1
Phase 1, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of an Enterovirus D68-specific Monoclonal Antibody in Healthy Adults
United States36 participantsStarted 2024-06-26
Plain-language 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.
Who can participate
Age range18 Years – 49 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
✓. Females of childbearing potential must agree to not donate ova or oocytes during the study.
Exclusion criteria
✕. 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.
What they're measuring
1
Number of Participants Experiencing Solicited Adverse Events (AEs) Through 48 Hours Post-infusion
Timeframe: Day 1 (post-infusion) through 48 hours post-infusion
2
Number of Participants Experiencing Unsolicited AEs - Including Clinical and Laboratory AEs - Through Day 29
Timeframe: Day 1 (post-infusion) through Day 29
3
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
Timeframe: Day 1 (post-infusion) through Day 121
Trial details
NCT IDNCT06444048
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
✕. Body mass index (BMI) 18 kg/m2 to 32 kg/m2, inclusive, and a weight of 125 kg or less at time of screening.
✕0. Must have adequate venous access for intravenous (IV) infusion and blood sampling.
✕. 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.