Diarrhea InfectiousPhase 1MBL-ETEC-21-01NCT06896136
Study in Healthy Adults Challenged With Enterotoxigenic E. Coli, of the Safety, Tolerability and Anti-Diarrheal Activity of VENBETA6890, an Orally Administered, Human Monoclonal IgA
A Phase 1 study testing VENBETA6890 in people with Diarrhea Infectious, run by Mark Klempner at 1 site in United States.
Trial summary
This is a phase 1, randomized, placebo-controlled, blinded study in up to 36 healthy adults, aged 18-45 years, challenged with Enterotoxigenic Escherichia coli, evaluating the safety, tolerability and anti-diarrheal activity of VENBETA6890, an orally administered, human monoclonal IgA. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Diarrhea Infectious
- What is being tested?
- VENBETA6890
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2025to 22 May 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Male or female ages 18-45 years, inclusive at screening 2. Body weight 50 to 105 kg, inclusive at screening 3. Provide written informed consent before initiation of any study procedures. 4. Willing and able to complete all study requirements, restrictions, confinement to the Research Isolation ward, visits and procedures 5. Completion of a training session and demonstration of comprehension of the protocol procedures and knowledge of ETEC-associated illness by passing a written examination (passing grade is at least 70%).
- 6. Healthy as judged by the Principal Investigator (PI) and determined by medical history, physical examination, medication history, and laboratory assessments.
- 7. At Screening: Normal to Grade 1 values14 for the following laboratory determinations:
- Complete Blood Count: WBC, absolute neutrophil count (ANC), hemoglobin, and platelet count
- IgA
- Comprehensive Metabolic Panel: creatinine, alanine aminotransferase (ALT), and total bilirubin
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- Urine protein and urine glucose
- Urine illicit drug (positive cannabis allowed) and serum alcohol screening
- Willingness to comply with COVID-19 screening PCR testing prior to dosing 8. Female subjects must be of non-childbearing potential (as defined as surgically sterile or postmenopausal for more than 1 year), or if of childbearing potential must be practicing abstinence or using an effective licensed method of birth control (e.g., history of hysterectomy or tubal ligation; use hormonal or barrier birth control such as implants, injectables, combined oral contraceptives, contraceptive patches, some intrauterine devices (IUDs), cervical sponges, diaphragms, condoms with spermicidal agents; or must have a vasectomized partner) within 28-days prior to the administration of VENBETA6890 or placebo and must agree to continue such precautions for 28 days after the last dose. A woman is eligible if she is monogamous with a vasectomized male.
- Male subjects with female sexual partner(s) of reproductive potential must fall into one of the following categories to qualify for enrollment:
- Documented to be surgically sterilized (defined as having successfully undergone vasectomy at least 90 days prior to Screening)
- Must agree to use a physical barrier method of contraception (e.g., a male condom) in addition to their partner's use (if partner is a WOCBP) of a birth control method from the time of Screening until 90 days after the last dose of study drug. The following methods of contraception are acceptable for use by female partners (if WOCBP) of male subjects:
- Oral, implantable, transdermal, injectable, or intravaginal hormonal contraception taken for at least 90 days prior to Screening
- Intrauterine device (IUD [copper or hormonal])
- Contraceptive sponge with condom Male subjects must agree not to donate sperm from the time of Check-in through 90 days after the final dose of study drug 9. Agrees to avoid live-culture yogurt and other probiotics for at least 14 days prior to the first dose of VENBETA6890 and during the study.
- 10. Agrees not to participate in another clinical trial during the study period.
Who cannot join
- 1. Positive pregnancy test at Screening or within 24 h prior to VENBETA6890 or placebo dosing 2. Breastfeeding 3. Poor venous access, as defined by inability to obtain venous blood, for screening labs, after 3 venipuncture attempts 4. Abnormal vital signs, defined as:
- Systolic BP >150 mmHg or Diastolic BP >90 mmHg
- Resting heart rate >100 bpm
- Temperature ≥38.0°C 5. Abnormal electrocardiogram (ECG) parameters, defined as:
- PR>220 msec
- QRS>120 msec
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- QTcF>450 msec for males or >460 msec for females 6. IgA deficiency 7. Evidence of current or past infection with testing for human immunodeficiency virus (HIV), hepatitis C virus (HCV) antibody, or Hepatitis B triple screening panel (Hepatitis B surface antigen, Hepatitis B surface antibody, Hepatitis B total core antibody) with confirmatory testing as indicated.
- 8. Having received prior vaccines for or have had prior infection with ETEC, Heat-Labile Toxin (LT), cholera, Campylobacter, or Shigella, within the past 3 years 9. History of diarrhea during travel to a developing country within the past 3 years 10. History of chronic gastrointestinal illness, including severe dyspepsia, lactose intolerance, or another significant gastrointestinal tract disease (e.g., irritable bowel syndrome, inflammatory bowel syndrome, gastric ulcer disease) 11. Regular use (≥ once weekly) of laxatives, anti-diarrheal agents, anti-constipation agents, or antacid therapies 12. History of major gastrointestinal surgery (uncomplicated laparoscopic appendectomy or cholecystectomy >1-year prior is permitted) 13. Abnormal bowel habits, as defined by <3 stools per week or >2 stools per day in the past 6 months 14. Use of systemic antibiotics within the past 2 weeks prior to Day 1 15. Use of topical (skin), otic, or ophthalmic antibiotics is acceptable, if those doses are not expected to result in significant systemic absorption levels 16. Use of oral, parenteral or high-dose inhaled steroids within 30 days. High-dose oral or parenteral steroids is defined as ≥20 mg total daily dose, or equivalent dose of other glucocorticoids; high-dose inhaled steroids is defined as >800 μg/day of beclomethasone dipropionate or equivalent.
- 17. Use of any medication which might affect immune function within 30 days
- Examples include anti-cancer drugs, immunomodulating monoclonal antibody therapeutics, and rheumatologic therapies 18. Diagnosis of schizophrenia or other major psychiatric disease 19. Alcohol or drug abuse within last 5 years; current smokers or use of nicotine in any form within 6 months prior to screening and until after end of study.
- 20. Presence of immunosuppression, which could be due to active neoplastic disease or a history of any hematologic malignancy (excluding resolved non-melanoma skin cancers), radiation therapy, or primary or secondary immunodeficiencies 21. History of allergy to quinolone (e.g., ciprofloxacin) or sulfa drugs (e.g., trimethoprim-sulfamethoxazole) 22. Known history of seizure disorder (remote history of a childhood seizure disorder which has completely resolved is acceptable) 23. Has consumed any nutrients or drugs with known strong cytochrome P450 3A4/5 (CYP3A4/5) inhibitors or inducers or P-glycoprotein inhibitors or inducers, starting from 14 days prior to Day 1 until the completion of study procedures at the end of study 24. Another investigational medication within 60 days or 5 half-lives, whichever is longer prior to Day 1 25. Participation in an investigational device study within 60 days prior to Day 1 26. Consumption of prescription and over-the-counter medication (including topical medications), traditional Chinese medicine, or herbal medicine, vitamin, mineral, plant, and other dietary supplements within 14 days or 5 half-lives, whichever is longer, prior to Day 1 and throughout the study 27. Consumption of liquids or foods containing grapefruit or cranberry from 7 days prior to Day 1 (Part A) or Check-in (Part B) and throughout the study 28. Consumption of any food containing poppy seeds from 48 h prior to Day 1 (Part A) or Check-in (Part B) and throughout the study 29. Donation of bone marrow or peripheral stem cells within 90 days prior to Day 1 or blood or plasma within 60 days prior to Day 1 30. Participation in strenuous exercise within 72 h prior to Day 1 (Part A) or Check-in (Part B) 31. Consumption of caffeine-containing substances within 72 h prior to Day 1 (Part A) or Check-in (Part B) 32. Occupation involving the handling of ETEC, cholera, or Shigella bacteria 33. Occupation in food handling industry or care of: very young children (<2 years old), elderly (≥70 years) or immunocompromised 34. Any other criteria which, in the investigator's opinion, would compromise the safety of the study, the ability of a subject to participate, or the results of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1, Randomized, Placebo-Controlled, Blinded Study in Healthy Adults Challenged With Enterotoxigenic Escherichia Coli, of the Safety, Tolerability and Anti-Diarrheal Activity of VENBETA6890, an Orally Administered, Human Monoclonal IgA
This is a phase 1, randomized, placebo-controlled, blinded study in up to 36 healthy adults, aged 18-45 years, challenged with Enterotoxigenic Escherichia coli, evaluating the safety, tolerability and anti-diarrheal activity of VENBETA6890, an orally administered, human monoclonal IgA.
Read the detailed description
Part A will consist of 1 sentinel dosing group of 2 subjects randomized 1:1 to receive VENBETA6890 or placebo and will evaluate VENBETA6890 at dose levels of 15 mg/kg. On Day 1, subjects will receive 15 mg/kg in the morning and a second dose of 15 mg/kg 8 - 12 h later in the outpatient clinic. On Day 2, they will receive a third dose of 15 mg/kg at approximately 8 - 12 h after the last dose on Day 1. The occurrence of local and systemic reactogenicity (solicited AEs) over the subsequent 7-days post-dosing will be collected; non-solicited non-serious AEs will be collected through 28-days post-dosing and serious adverse events (SAEs) will be collected through 2 months. An independent Safety Monitoring Committee (SMC) will review the cumulative 7-day safety data for the sentinel group and must approve for the study to proceed to Part B.
Part B will consist of a single inpatient cohort of up to 34 subjects who will be randomized 1:1 to receive VENBETA6890 15 mg/kg, or placebo on Day -1 at approximately 12 h pre-challenge, Day 1 at approximately 1 h pre-challenge, and Day 1 at approximately 12 h post-challenge. All subjects will be challenged with wild-type ETEC strain H10407 and will be closely monitored on the inpatient unit for ETEC diarrheal illness. Subjects will receive the 3-day course of antibiotic therapy starting on Day 6 or earlier dependent on symptoms. Discharge from the inpatient unit is contingent upon the absence of ETEC diarrheal illness, including no diarrhea and no fever, plus two sequential negative stool cultures for ETEC separated by at least 12 hours.
An SMC will review the cumulative safety data after data collected during the Day 29 visit of the inpatient challenge cohort has been compiled.
- Conditions
- Diarrhea Infectious
- Being tested
- VENBETA6890, Placebo
- Keywords
- ETEC, Diarrhea, Oral Prophylaxis
- Medical subject headings
- Dysentery, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VENBETA6890Drug
Part A will consist of 1 sentinel dosing group of 2 subjects randomized 1:1 to receive VENBETA6890 and will evaluate VENBETA6890 at dose levels of 15 mg/kg. On Day 1, subjects will receive 15 mg/kg in the morning and a second dose of 15 mg/kg 8 - 12 h later in the outpatient clinic. On Day 2, they will receive a third dose of 15 mg/kg at approximately 8 - 12 h after the last dose on Day 1.
PlaceboDrug
Part A Placebo (saline) will be administered at dose levels of 15 mg/kg. On Day 1, subjects will receive 15 mg/kg in the morning and a second dose of 15 mg/kg 8 - 12 h later in the outpatient clinic. On Day 2, they will receive a third dose of 15 mg/kg at approximately 8 - 12 h after the last dose on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Part A arm 1 Investigational Product | Experimental | Arm 1 Investigational product - Venbeta Receives: Drug: VENBETA6890 |
| Part A Arm 2 | Placebo comparator | Part A Arm 2 Placebo Receives: Drug: Placebo |
| Part B Arm 2 | Placebo comparator | Part B Arm 2 Particpants receive placebo. Receives: Drug: Placebo |
| Part B Arm 1 | Experimental | Part B Arm 1 Participants receive Investigational Product Receives: Drug: VENBETA6890 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants who Experience Treatment Emergent Adverse Events
The number of participants who experience treatment emergent adverse events. Severity of Treatment Emergent Adverse Events (TEAEs) are determined by changes in vital signs (VS), Physical examination (PE), and routine clinical laboratory tests.
Measured: up to day 60
Proportion of Participants who experience treatment emergent adverse events.
Severity of Treatment Emergent Adverse Events (TEAEs) are determined by changes in vital signs (VS), Physical examination (PE), and routine clinical laboratory tests.
Measured: up to 60 days
Secondary outcomes (2)
Number of participants experiencing diarrhea after enterotoxigenic E.coli (ETEC) challenge
This outcome is measuring the number of participants who experience diarrhea after ETEC challenge. DIARRHEA is defined as at least 1 loose stool (stool consistency of Grade 3 or higher per protocol definition) of ≥ 300 g or at least 2 loose stools totaling ≥ 200 g during any 48-hour period
Measured: 120 hours post challenge
Proportion of participants experiencing diarrhea after ETEC challenge
This outcome is measuring the proportion of participants who experience diarrhea after ETEC challenge. DIARRHEA is defined as at least 1 loose stool (stool consistency of Grade 3 or higher per protocol definition) of ≥ 300 g or at least 2 loose stools totaling ≥ 200 g during any 48-hour period
Measured: 120 hours post challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start11 Feb 2025
- Primary completion22 May 2025
- Study completion22 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diarrhea InfectiousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mark Klempner
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Pharmaron CPC, Inc., University of Maryland
- Responsible party
- Sponsor-investigator, Mark Klempner, University of Massachusetts, Worcester
- Investigators
- Sponsor Investigator, MD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06896136
- Sponsor's protocol ID
- Pro00084264
- Acronym
- MBL-ETEC-21-01
- Status last verified
- Jul 2025
- First submitted
- 19 Mar 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Randomized, Placebo-Controlled, Blinded Study in Healthy Adults Challenged With Enterotoxigenic Escherichia Coli, of the Safety, Tolerability and Anti-Diarrheal Activity of VENBETA6890, an Orally Administered, Human Monoclonal IgA
- ClinicalTrials.gov ID
- NCT06896136
- Acronym / sponsor ID
- MBL-ETEC-21-01 / Pro00084264
- Conditions
- Diarrhea Infectious
- Keywords
- ETEC, Diarrhea, Oral Prophylaxis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Mark KlempnerUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Pharmaron CPC, Inc., University of Maryland
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- 22 May 2025 (actual)
- Study completion
- 22 May 2025 (actual)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 1, randomized, placebo-controlled, blinded study in up to 36 healthy adults, aged 18-45 years, challenged with Enterotoxigenic Escherichia coli, evaluating the safety, tolerability and anti-diarrheal activity of VENBETA6890, an orally administered, human monoclonal IgA.
Detailed description
Part A will consist of 1 sentinel dosing group of 2 subjects randomized 1:1 to receive VENBETA6890 or placebo and will evaluate VENBETA6890 at dose levels of 15 mg/kg. On Day 1, subjects will receive 15 mg/kg in the morning and a second dose of 15 mg/kg 8 - 12 h later in the outpatient clinic. On Day 2, they will receive a third dose of 15 mg/kg at approximately 8 - 12 h after the last dose on Day 1. The occurrence of local and systemic reactogenicity (solicited AEs) over the subsequent 7-days post-dosing will be collected; non-solicited non-serious AEs will be collected through 28-days post-dosing and serious adverse events (SAEs) will be collected through 2 months. An independent Safety Monitoring Committee (SMC) will review the cumulative 7-day safety data for the sentinel group and must approve for the study to proceed to Part B.
Part B will consist of a single inpatient cohort of up to 34 subjects who will be randomized 1:1 to receive VENBETA6890 15 mg/kg, or placebo on Day -1 at approximately 12 h pre-challenge, Day 1 at approximately 1 h pre-challenge, and Day 1 at approximately 12 h post-challenge. All subjects will be challenged with wild-type ETEC strain H10407 and will be closely monitored on the inpatient unit for ETEC diarrheal illness. Subjects will receive the 3-day course of antibiotic therapy starting on Day 6 or earlier dependent on symptoms. Discharge from the inpatient unit is contingent upon the absence of ETEC diarrheal illness, including no diarrhea and no fever, plus two sequential negative stool cultures for ETEC separated by at least 12 hours.
An SMC will review the cumulative safety data after data collected during the Day 29 visit of the inpatient challenge cohort has been compiled.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A arm 1 Investigational Product | Experimental | Drug: VENBETA6890Arm 1 Investigational product - Venbeta |
| Part A Arm 2 | Placebo comparator | Drug: PlaceboPart A Arm 2 Placebo |
| Part B Arm 2 | Placebo comparator | Drug: PlaceboPart B Arm 2 Particpants receive placebo. |
| Part B Arm 1 | Experimental | Drug: VENBETA6890Part B Arm 1 Participants receive Investigational Product |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 1. Male or female ages 18-45 years, inclusive at screening 2. Body weight 50 to 105 kg, inclusive at screening 3. Provide written informed consent before initiation of any study procedures. 4. Willing and able to complete all study requirements, restrictions, confinement to the Research Isolation ward, visits and procedures 5. Completion of a training session and demonstration of comprehension of the protocol procedures and knowledge of ETEC-associated illness by passing a written examination (passing grade is at least 70%).
- 6. Healthy as judged by the Principal Investigator (PI) and determined by medical history, physical examination, medication history, and laboratory assessments.
- Male subjects with female sexual partner(s) of reproductive potential must fall into one of the following categories to qualify for enrollment:
- Documented to be surgically sterilized (defined as having successfully undergone vasectomy at least 90 days prior to Screening)
- Must agree to use a physical barrier method of contraception (e.g., a male condom) in addition to their partner's use (if partner is a WOCBP) of a birth control method from the time of Screening until 90 days after the last dose of study drug. The following methods of contraception are acceptable for use by female partners (if WOCBP) of male subjects:
Key exclusion criteria (11 listed)
- 1. Positive pregnancy test at Screening or within 24 h prior to VENBETA6890 or placebo dosing 2. Breastfeeding 3. Poor venous access, as defined by inability to obtain venous blood, for screening labs, after 3 venipuncture attempts 4. Abnormal vital signs, defined as:
- 8. Having received prior vaccines for or have had prior infection with ETEC, Heat-Labile Toxin (LT), cholera, Campylobacter, or Shigella, within the past 3 years 9. History of diarrhea during travel to a developing country within the past 3 years 10. History of chronic gastrointestinal illness, including severe dyspepsia, lactose intolerance, or another significant gastrointestinal tract disease (e.g., irritable bowel syndrome, inflammatory bowel syndrome, gastric ulcer disease) 11. Regular use (≥ once weekly) of laxatives, anti-diarrheal agents, anti-constipation agents, or antacid therapies 12. History of major gastrointestinal surgery (uncomplicated laparoscopic appendectomy or cholecystectomy >1-year prior is permitted) 13. Abnormal bowel habits, as defined by <3 stools per week or >2 stools per day in the past 6 months 14. Use of systemic antibiotics within the past 2 weeks prior to Day 1 15. Use of topical (skin), otic, or ophthalmic antibiotics is acceptable, if those doses are not expected to result in significant systemic absorption levels 16. Use of oral, parenteral or high-dose inhaled steroids within 30 days. High-dose oral or parenteral steroids is defined as ≥20 mg total daily dose, or equivalent dose of other glucocorticoids; high-dose inhaled steroids is defined as >800 μg/day of beclomethasone dipropionate or equivalent.
- 17. Use of any medication which might affect immune function within 30 days
- Examples include anti-cancer drugs, immunomodulating monoclonal antibody therapeutics, and rheumatologic therapies 18. Diagnosis of schizophrenia or other major psychiatric disease 19. Alcohol or drug abuse within last 5 years; current smokers or use of nicotine in any form within 6 months prior to screening and until after end of study.
- 20. Presence of immunosuppression, which could be due to active neoplastic disease or a history of any hematologic malignancy (excluding resolved non-melanoma skin cancers), radiation therapy, or primary or secondary immunodeficiencies 21. History of allergy to quinolone (e.g., ciprofloxacin) or sulfa drugs (e.g., trimethoprim-sulfamethoxazole) 22. Known history of seizure disorder (remote history of a childhood seizure disorder which has completely resolved is acceptable) 23. Has consumed any nutrients or drugs with known strong cytochrome P450 3A4/5 (CYP3A4/5) inhibitors or inducers or P-glycoprotein inhibitors or inducers, starting from 14 days prior to Day 1 until the completion of study procedures at the end of study 24. Another investigational medication within 60 days or 5 half-lives, whichever is longer prior to Day 1 25. Participation in an investigational device study within 60 days prior to Day 1 26. Consumption of prescription and over-the-counter medication (including topical medications), traditional Chinese medicine, or herbal medicine, vitamin, mineral, plant, and other dietary supplements within 14 days or 5 half-lives, whichever is longer, prior to Day 1 and throughout the study 27. Consumption of liquids or foods containing grapefruit or cranberry from 7 days prior to Day 1 (Part A) or Check-in (Part B) and throughout the study 28. Consumption of any food containing poppy seeds from 48 h prior to Day 1 (Part A) or Check-in (Part B) and throughout the study 29. Donation of bone marrow or peripheral stem cells within 90 days prior to Day 1 or blood or plasma within 60 days prior to Day 1 30. Participation in strenuous exercise within 72 h prior to Day 1 (Part A) or Check-in (Part B) 31. Consumption of caffeine-containing substances within 72 h prior to Day 1 (Part A) or Check-in (Part B) 32. Occupation involving the handling of ETEC, cholera, or Shigella bacteria 33. Occupation in food handling industry or care of: very young children (<2 years old), elderly (≥70 years) or immunocompromised 34. Any other criteria which, in the investigator's opinion, would compromise the safety of the study, the ability of a subject to participate, or the results of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VENBETA6890Part A will consist of 1 sentinel dosing group of 2 subjects randomized 1:1 to receive VENBETA6890 and will evaluate VENBETA6890 at dose levels of 15 mg/kg. On Day 1, subjects will receive 15 mg/kg in the morning and a second dose of 15 mg/kg 8 - 12 h later in the outpatient clinic. On Day 2, they will receive a third dose of 15 mg/kg at approximately 8 - 12 h after the last dose on Day 1. | Drug | Part A arm 1 Investigational Product, Part B Arm 1 |
| PlaceboPart A Placebo (saline) will be administered at dose levels of 15 mg/kg. On Day 1, subjects will receive 15 mg/kg in the morning and a second dose of 15 mg/kg 8 - 12 h later in the outpatient clinic. On Day 2, they will receive a third dose of 15 mg/kg at approximately 8 - 12 h after the last dose on Day 1. | Drug | Part A Arm 2, Part B Arm 2 |
Primary outcome
Number of Participants who Experience Treatment Emergent Adverse Events
Time frame: up to day 60
The number of participants who experience treatment emergent adverse events. Severity of Treatment Emergent Adverse Events (TEAEs) are determined by changes in vital signs (VS), Physical examination (PE), and routine clinical laboratory tests.
Proportion of Participants who experience treatment emergent adverse events.
Time frame: up to 60 days
Severity of Treatment Emergent Adverse Events (TEAEs) are determined by changes in vital signs (VS), Physical examination (PE), and routine clinical laboratory tests.
2 secondary outcomes
Number of participants experiencing diarrhea after enterotoxigenic E.coli (ETEC) challenge
Time frame: 120 hours post challenge
Proportion of participants experiencing diarrhea after ETEC challenge
Time frame: 120 hours post challenge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sponsor Investigator, MD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VENBETA6890 in people with Diarrhea Infectious, run by Mark Klempner at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants who Experience Treatment Emergent Adverse Events (time frame: up to day 60). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.