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Virus Therapy
Study of Efficacy and Safety of ABO809 in Healthy Participants
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.
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 moreSide effects data
From 2022 Phase 1 trial • 30 Patients • NCT0503666870%
Diarrhoea
50%
Headache
50%
Decreased appetite
45%
Abdominal pain
45%
Tachycardia
30%
Haematochezia
30%
Vomiting
30%
Defaecation urgency
25%
Nausea
20%
Dizziness
20%
Pyrexia
20%
Dehydration
20%
Back pain
20%
Flatulence
15%
Abdominal tenderness
15%
Body temperature increased
10%
Constipation
10%
Chills
5%
Abdominal distension
5%
Nasal congestion
5%
Orthostatic hypotension
5%
Rectal tenesmus
5%
Occult blood
5%
Pain
5%
Lipase increased
5%
Fatigue
5%
Hypotension
5%
Oropharyngeal pain
5%
Cough
5%
Aspartate aminotransferase increased
5%
Blood creatine phosphokinase increased
5%
Chromaturia
5%
Night sweats
5%
Hot flush
5%
Occult blood positive
5%
Proctalgia
5%
Dyspepsia
100%
80%
60%
40%
20%
0%
Study treatment Arm
ABO809 1x10^6 CE - Cohorts 2 and 3
Total
ABO809 1x10^6 CE-Cohort 2
ABO809 1x10^4 CE - Cohort 1
ABO809 1x10^6 CE-Cohort 3
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
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,920 Previous Clinical Trials
4,254,657 Total Patients Enrolled
Mohamed Al-IbrahimPrincipal InvestigatorPharmaron CPC, Inc.
1 Previous Clinical Trials
24 Total Patients Enrolled