Monoclonal Antibody for Enterovirus Infections

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety of a new treatment, EV68-228-N (a monoclonal antibody), for enterovirus infections. Enteroviruses are common viruses that can cause mild to severe illnesses. Participants will receive different doses of the treatment to observe its effects. The trial seeks healthy adults without serious medical conditions or allergies to certain substances.

As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop all current medications, but you cannot use certain medications like systemic immunosuppressive drugs, oral corticosteroids, or systemic anti-cancer drugs within 30 days before starting the trial. It's best to discuss your current medications with the trial team to see if they are allowed.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that EV68-228-N, a monoclonal antibody treatment, has shown promise in early studies. In tests with mice, it protected against the breathing and nerve problems caused by EV-D68, a virus that usually leads to mild respiratory illness. While these findings are hopeful, it is important to remember that this is a Phase 1 trial. Phase 1 trials primarily focus on assessing the safety of a treatment, meaning they are just beginning to evaluate how well people can tolerate it. Researchers are still gathering information about its safety in humans, but these early trials are crucial to ensure the treatment's safety before progressing to larger studies. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about EV68-228-N because it represents a novel approach to treating enterovirus infections, which currently lack specific antiviral drugs. Unlike existing care, which primarily involves supportive measures like hydration and pain relief, this treatment uses a monoclonal antibody that specifically targets and neutralizes the virus. This targeted action could potentially offer a more effective way to control the infection and reduce symptoms quickly. Additionally, the treatment is delivered through a single intravenous infusion, which may provide faster results compared to more prolonged oral medication courses.

What evidence suggests that this treatment might be an effective treatment for enterovirus infections?

Research has shown that the monoclonal antibody EV68-228-N, which participants in this trial may receive, may help fight enterovirus infections. In lab studies, EV68-228-N successfully stopped paralysis caused by various strains of enterovirus D68. This suggests the antibody might be useful in treating illnesses caused by similar viruses. Although this research remains in the early stages, the initial results are promising for its potential use in treating enterovirus-related diseases. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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

Has any medical disease or condition that precludes study participation

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11980581/

EV68-228-N monoclonal antibody treatment halts ... We found that EV68-228-N effectively halted the progression of paralysis when tested against both 2014 and 2016 EV-D68 isolates in an ...

2. academic.oup.com academic.oup.com/ofid/article/11/11/ofae656/7882874

Enterovirus D68: Genomic and Clinical Comparison of 2 ... Our results show significant differences in the clinical outcomes of EV-D68 infections ... data that include prior infections or vaccinations.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06444048

Study Details | NCT06444048 | Phase 1, Randomized, ... 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 ...

4. pharmaceutical-technology.com pharmaceutical-technology.com/data-insights/ev68-228-n-kbio-enterovirus-infections-likelihood-of-approval/

EV68-228-N by KBio for Enterovirus Infections According to GlobalData, Phase I drugs for Enterovirus Infections have an 83% phase transition success rate (PTSR) indication benchmark for ...

5. nature.com nature.com/articles/s42003-025-08253-y

Structural insights from vaccine candidates for EV-D68 These vaccines have demonstrated safety, efficient production, and high effectiveness in preventing viral infections and associated diseases.

6. cdc.gov cdc.gov/non-polio-enterovirus/about/about-enterovirus-d68.html

About Enterovirus D68 EV-D68 typically causes respiratory illness, which can be mild (like a common cold) or more serious. Children with asthma may have a higher ...

7. niaid.nih.gov niaid.nih.gov/news-events/nih-sponsored-trial-enterovirus-d68-therapeutic-begins

NIH-Sponsored Trial of Enterovirus D68 Therapeutic Begins EV-D68 typically causes respiratory illnesses that are mild. Non-polio enteroviruses are very common. Most infections are asymptomatic or cause ...

8. news.unchealthcare.org news.unchealthcare.org/2024/06/antibody-trial-launched-to-address-enterovirus-threat/

Antibody Trial Launched to Address Enterovirus Threat One of the potently neutralizing antibodies against EV-D68 they isolated, EV68-228, protected mice from respiratory and neurologic disease when ...