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Virus Therapy

Cryptosporidium parvum oocysts (ABO809) for Cryptosporidiosis

Phase 1

Waitlist Available

Led By Mohamed Al-Ibrahim

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up adverse events were reported from oral administration of abo809 up to a maximum duration of 56 days.

Awards & highlights

No Placebo-Only Group

Summary

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.

Eligible Conditions

Cryptosporidiosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ adverse events were reported from oral administration of abo809 up to a maximum duration of 56 days.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~adverse events were reported from oral administration of abo809 up to a maximum duration of 56 days.

This trial's timeline: 3 weeks for screening, Varies for treatment, and adverse events were reported from oral administration of abo809 up to a maximum duration of 56 days. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants With Cryptosporidium Infection From 72 Hours to 10 Days Post ABO809 Oral Administration

Secondary study objectives

Maximum Stool Grade by Stool Grade Category

Number of Diarrhea Stools Per Participant

Number of Participants With Adverse Events of Special Interest (AESIs)

+9 more

Side effects data

From 2022 Phase 1 trial • 30 Patients • NCT05036668

80%

Diarrhoea

70%

Abdominal pain

60%

Headache

60%

Tachycardia

60%

Decreased appetite

50%

Vomiting

40%

Nausea

30%

Haematochezia

30%

Body temperature increased

20%

Pyrexia

20%

Dizziness

20%

Abdominal tenderness

20%

Defaecation urgency

20%

Dehydration

20%

Back pain

20%

Flatulence

10%

Occult blood

10%

Oropharyngeal pain

10%

Aspartate aminotransferase increased

10%

Hypotension

10%

Dyspepsia

10%

Pain

10%

Cough

10%

Nasal congestion

10%

Proctalgia

10%

Constipation

100%

80%

60%

40%

20%

Study treatment Arm

ABO809 1x10^6 CE-Cohort 2

ABO809 1x10^4 CE - Cohort 1

ABO809 1x10^6 CE - Cohorts 2 and 3

ABO809 1x10^6 CE-Cohort 3

Total

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: ABO809Experimental Treatment1 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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cryptosporidium parvum oocysts (ABO809)

2022

Completed Phase 1

~30

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