Study of Efficacy and Safety of ABO809 in Healthy Participants

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

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial involves giving healthy volunteers a specific amount of a parasite to see if it causes infection and diarrhea. Researchers aim to understand how the body reacts by monitoring for signs of infection and related symptoms. Healthy individuals are chosen to ensure clear observation of the infection process.

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 ABO809 generally safe for humans?

The safety of ABO809 in humans is not directly addressed in the provided research articles. However, general information about adverse event reporting in clinical trials suggests that new and unexpected safety concerns can emerge after a drug is widely used. It's important to monitor for adverse events and consult with healthcare professionals for specific safety information about ABO809. ^{1 2 3 4 5}

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]

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

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

2. Australia pubmed.ncbi.nlm.nih.gov

Surveillance of adverse events following immunisation in Australia annual report, 2017 [2020]

3. Australia pubmed.ncbi.nlm.nih.gov

NSW annual report describing adverse events following immunisation, 2011. [2014]

4. United States pubmed.ncbi.nlm.nih.gov

Adverse drug events: identification and attribution. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

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