ABO809 for Cryptosporidiosis

No longer recruiting at 1 trial location

Overseen By Novartis Pharmaceuticals

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Novartis Pharmaceuticals

Must not be taking: Nitazoxanide, Antibiotics

Disqualifiers: Cryptosporidium, Gastrointestinal, Immunodeficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ABO809 (experimental treatment) to determine if it can safely induce a specific type of infection, known as Cryptosporidium, in healthy volunteers. Cryptosporidium is a parasite that can cause diarrhea and other stomach issues. The main goal is to understand the body's reaction and monitor for any symptoms or signs of infection. The trial seeks participants who are generally healthy and understand the risks associated with Cryptosporidium. Participants must not have had any past infections or major stomach problems. As a Phase 1 trial, this research aims to understand how ABO809 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team.

Is there any evidence suggesting that ABO809 is likely to be safe for humans?

Research shows that the safety of ABO809 in humans remains under exploration. This treatment is currently in a Phase 1 trial, the initial step in human testing. Phase 1 trials primarily focus on safety, assessing how well participants tolerate the treatment and identifying any side effects.

As an early-stage trial, detailed safety information may be limited. However, the testing of ABO809 in humans suggests that earlier lab and animal studies did not reveal major safety concerns. Phase 1 trials typically involve a small number of participants, who are closely monitored for any adverse effects.

Prospective participants should know that researchers will carefully monitor for any safety issues. This information will help determine whether it is safe to include more participants in future studies. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about ABO809 because it offers a novel approach by using oocysts, which could provide a more targeted and potentially more effective treatment method compared to existing options. Most treatments for similar conditions rely on broad-spectrum drugs that may not specifically target the underlying issue. ABO809's unique mechanism involves delivering a specific dose of oocysts, which could optimize efficacy and safety. This innovative strategy might lead to a more efficient and quicker response, making it a promising candidate in the realm of emerging therapies.

What evidence suggests that ABO809 might be an effective treatment for Cryptosporidium infection?

Research shows that ABO809 is being tested in this trial to determine if it can consistently cause a Cryptosporidium infection in healthy people. This is crucial for developing treatments, as it establishes a reliable method to study the illness. The goal is to discover if a specific amount of the parasite leads to infection and diarrhea. Initial studies focus on how effectively the treatment induces these conditions, rather than curing them. This approach helps researchers better understand the disease process. Information from this trial will be vital for future research into treatments for Cryptosporidium infections. ^{1 3 4 6 7}

Who Is on the Research Team?

Mohamed Al-Ibrahim

Principal Investigator

Pharmaron CPC, Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

Demonstrated understanding of Cryptosporidium disease, safety measures and transmission risks

Good health

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single oral dose of ABO809 to induce Cryptosporidium infection

1 day

1 visit (in-person)

Inpatient Monitoring

Participants are monitored for infection and diarrheal illness with stool samples collected up to 3 times per day

10 days

Daily monitoring (in-person)

Outpatient Follow-up

Participants continue to be monitored for diarrheal illness and Cryptosporidium infection resolution

18 days

Regular follow-up visits (in-person)

Long-term Follow-up

Participants are monitored for adverse events and long-term effects

28 days

What Are the Treatments Tested in This Trial?

Interventions

• ABO809

How Is the Trial Designed?

Group I: ABO809 Experimental Treatment 1 Intervention

Participants will receive ABO809 at a single oral dose of 1x10\^4 oocysts. Other doses such as 1x10\^6 oocysts may be considered to optimize the model

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Published Research Related to This Trial

The web-based adverse event tracking system (eAETS) has effectively supported 175 clinical protocols over four years, capturing 2,440 adverse event reports, including minor symptoms that could indicate serious issues.

Out of the reported AEs, 1,053 did not align with the initial risk profiles, leading to corrective recommendations in 13% of the protocols, highlighting the system's role in enhancing subject safety by identifying unanticipated patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of minor adverse event tracking on subject safety: a web-based system. Shenvi, NV., Gebhart, SS.[2009]

Adverse event reporting in randomized clinical trials (RCTs) is often inadequate, leading to potential safety concerns for new drugs once they are used in larger, more diverse patient populations.

The article highlights specific shortcomings in AE reporting for tumor necrosis factor (TNF) inhibitors, including issues with time-to-event reporting, standardized incidence ratios, and insufficient sample sizes, which can obscure the true safety profile of these medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Some concerns about adverse event reporting in randomized clinical trials. Yazici, Y.[2008]

The definition of an adverse drug event (ADE) should be tailored to the specific purpose of the evaluation, with stricter definitions needed for scientific studies and more flexible ones for clinical use.

Postmarketing safety data for drugs is limited at launch, but can be supplemented through systems like the FDA's Spontaneous Reporting System and targeted research projects, emphasizing the importance of robust epidemiological evidence for regulatory actions like drug recalls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug events: identification and attribution. Rogers, AS.[2022]

Citations

1. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/68/NCT05036668/SAP_001.pdf

Clinical Development - ABO809 Participant-reported outcomes ... All data for background and demographic variables will be listed by ABO809 treatment group.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05036668?cond=%22Cryptosporidiosis%22&viewType=Table&rank=1

Study of Efficacy and Safety of ABO809 in Healthy Participants An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

3. ctv.veeva.com ctv.veeva.com/study/study-of-efficacy-and-safety-of-abo809-in-healthy-participants

Study of Efficacy and Safety of ABO809 in Healthy Participants The purpose of this Phase I controlled human infection model (CHIM) study was to determine if oral administration of a good manufacturing practice (GMP) supply ...

4. withpower.com withpower.com/trial/phase-1-cryptosporidiosis-11-2021-13988

Study of Efficacy and Safety of ABO809 in Healthy ... This trial involves giving healthy volunteers a specific amount of a parasite to see if it causes infection and diarrhea.

5. synapse.patsnap.com synapse.patsnap.com/drug/3bf110850bb4480ca8df4ff75afe07b2

KDU-731 - Drug Targets, Indications, Patents ... Efficacy and Safety of ABO809 in Healthy Participants. 100 Clinical Results ... A Phase 1 study in humans with a primary safety outcome and a secondary ...

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/68/NCT05036668/Prot_000.pdf

ABO809 An Open Label Cryptosporidium Controlled ... available safety data will be performed to determine if it is safe to dose additional participants in subsequent cohorts. The data to be ...

7. trial.medpath.com trial.medpath.com/clinical-trial/83de4e29729662a1/controlled-human-infection-study-trichuris-trichiura

Controlled Human Infection Study of Orally Administered Trichuris ... Adverse events related to abnormal clinical safety laboratory parameter (white blood cell count) values, Day of CHTI through final study visit on study Day 203.