Monoclonal Antibody for Enterovirus Infections

Recruiting at 3 trial locations

Overseen By C. Buddy Creech

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Must not be taking: Immunosuppressants, Corticosteroids, Antineoplastics, others

Disqualifiers: Pregnancy, Psychiatric conditions, Drug abuse, others

Compensation: Varies

Number of Visits: 10

Duration: 1 week

36 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Healthy adults can join this trial to test a new monoclonal antibody for Enterovirus D68. Participants must be in good health without any serious medical conditions or history of the infection being studied.

Inclusion Criteria

I am in good health overall, as confirmed by recent medical exams.

I can receive IV infusions and have blood drawn without issue.

Provides written informed consent prior to initiation of any study procedures

Exclusion Criteria

History of an infusion reaction to any biologic product

Known, current human immunodeficiency virus (HIV), hepatitis B Virus (HBV), or hepatitis C virus (HCV) infection

I have not taken, nor plan to take, any prohibited medications recently.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment

Participants receive a single intravenous infusion of EV68-228-N or placebo, with active monitoring for adverse events and safety laboratory data through Day 8

1 week

3 visits (in-person)

Follow-up

Participants are monitored for safety and pharmacokinetics, with follow-up visits on Days 8, 15, 29, 61, 91, and 121

16 weeks

6 visits (in-person)

Treatment Details

Interventions

• EV68-228-N

Trial Overview The study is testing different doses (3, 10, and 30 mg/kg) of EV68-228-N versus a placebo. It's designed to see how safe the drug is and how it moves through and out of the body over about four months.

Participant Groups

Group I: Cohort 3A Experimental Treatment 1 Intervention

Healthy adult participants will be randomized at a 5:1 ratio to receive a single intravenous infusion of EV68-228-N N=10 and Placebo (20mM Citrate + 10 mM Glycine, 8% Sucrose, and 0.01% Polysorbate 80) 30 mg/kg. N=2

Group II: Cohort 2A Experimental Treatment 1 Intervention

Healthy adult participants will be randomized at a 5:1 ratio to receive a single intravenous infusion of EV68-228-N and Placebo (20mM Citrate + 10 mM Glycine, 8% Sucrose, and 0.01% Polysorbate 80) 10 mg/kg. N=2

Group III: Cohort 1A Experimental Treatment 1 Intervention

Healthy adult participants will be randomized at a 5:1 ratio. 10 participants to receive a 3 mg/kg single intravenous infusion of EV68-228-N and 2 Participants matching Placebo (20mM Citrate + 10 mM Glycine, 8% Sucrose, and 0.01% Polysorbate 80)

Group IV: Cohort 1B Placebo Group 1 Intervention

Healthy adult participants will be randomized at a 5:1 ratio. 10 participants to receive a 3 mg/kg single intravenous infusion of EV68-228-N and 2 Participants matching Placebo (20mM Citrate + 10 mM Glycine, 8% Sucrose, and 0.01% Polysorbate 80)

Group V: Cohort 2B Placebo Group 1 Intervention

Healthy adult participants will be randomized at a 5:1 ratio to receive a single intravenous infusion of EV68-228-N and Placebo (20mM Citrate + 10 mM Glycine, 8% Sucrose, and 0.01% Polysorbate 80) 10 mg/kg. N=2

Group VI: Cohort 3B Placebo Group 1 Intervention

Healthy adult participants will be randomized at a 5:1 ratio to receive a single intravenous infusion of EV68-228-N N=10 and Placebo (20mM Citrate + 10 mM Glycine, 8% Sucrose, and 0.01% Polysorbate 80) 30 mg/kg. N=2

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

KBio Inc

Industry Sponsor

Trials

5

Recruited

320+