A Phase 2 interventional study of iOWH032 and Placebo in Cholera, sponsored by PATH. Completed at 1 site in United States. Open to participants aged 18 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-25.
Sponsored by PATH · Phase 2, Interventional, and Treatment
Among 12 studies in Cholera with a site in United States — 2 open to participants now, 2 under way, none of them phase 3. Cholera · United States.
Among the 12 studies in Cholera with a site in United States, this one is the 10th largest by enrollment, is the only one that started in 2019, is one of 2 in phase 2, and was the 11th registered.
83 studies on the registry are indexed under Cholera; 16 are open to participants now.
This study's enrollment of 47 is below the median of 262 across 72 interventional studies indexed under Cholera.
Browse Cholera studies →2 of the 12 studies in Cholera with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 13 Cholera studies recruiting now, 7 (54%) set no upper age limit and 5 (38%) stop at 75 or younger; 10 take children under 18; 9 take healthy volunteers.
This study: 18 Years to 44 Years · all sexes · healthy volunteers too.
The full table on the hub →12 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 1 started in 2019.
Median enrollment 132 across the 12 interventional studies. Of the 10 that completed or were terminated, 8 (80%) have results posted.
5 of 12 have an industry lead sponsor. The 7 most frequent:
PATH is the lead sponsor of 113 studies on the registry; 7 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 10 (100%) have results posted.
PATH has 4 studies filed under Cholera — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 12 studies in Cholera with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
This trial was designed to assess safety and preliminary efficacy of oral doses of iOWH032 on diarrhea output and clinical symptoms after a cholera challenge in healthy adult participants.
The study consists of a screening phase, an inpatient containment period with challenge with Vibrio cholerae on Day 1 followed by treatment with iOWH032 or placebo and a post-challenge observation period until discharge, an outpatient follow-up period of at least 28 days, and a final follow-up (by telephone) 6 months post-challenge (Day 180) for the collection of serious adverse events.
Participants will be randomized 1:1 to receive either iOWH032 500 mg every 8 hours for three days or matching placebo. Blinded therapeutic dosing will start at the onset of diarrhea or by 48 hours after ingesting the challenge inoculum of V. cholerae. The observation and management of cholera diarrhea and symptomatology will occur on an inpatient isolation research ward over a duration of approximately 11 days, including a three-day course of antibiotics to treat all participants prior to discharge from the inpatient unit.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Willing and able to comply with the study requirements and procedures.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
On Day 1, participants were challenged with 10\^6 colony-forming units (CFU) of freshly-harvested wild-type V. cholerae. At the onset of diarrhea, or at 48 hours after challenge, whichever occurred first, participants received oral iOWH032 500 mg tablets every 8 hours for 3 days. Participants received a 3-day course of antibiotics starting 4 days post-challenge, or sooner if the participant met the criterion for severe cholera diarrhea.
Drug: iOWH032 · Other: V. cholerae Challenge · Drug: Antibiotics
On Day 1, participants were challenged with 10\^6 CFU of freshly-harvested wild-type V. cholerae. At the onset of diarrhea, or at 48 hours after challenge, whichever occurred first, participants received oral matching iOWH032 placebo tablets every 8 hours for 3 days. Participants received a 3-day course of antibiotics starting 4 days post-challenge, or sooner if the participant met the criterion for severe cholera diarrhea.
Drug: Placebo · Other: V. cholerae Challenge · Drug: Antibiotics
Anti-secretory synthetically manufactured small molecule designed to inhibit the cystic fibrosis transmembrane conductance regulator chloride channel.
Oral tablets matching iOWH032 on taste, appearance, dissolution time with the same excipients but no active ingredients.
Freshly-harvested, wild-type Vibrio (V.) cholerae El Tor Inaba strain N16961,10\^6 cfu suspended in 30 mL of sodium bicarbonate solution ingested orally.
Antibiotic therapy may include: * Ciprofloxacin 500 mg, twice daily; * Azithromycin 500 mg, once daily (for those persons who are allergic to fluoroquinolones); * Doxycycline 300 mg, once daily (for those persons who are allergic to fluoroquinolones)
Diarrheal Stool Output Rate
Diarrheal stool output rate is defined as the total volume of diarrheal stools (in mL, Grade 3 and above) divided by the number of hours between initiation of study drug (iOWH032 or placebo) and initiation of antibiotic therapy. Stools were graded based on consistency as follows: * Grade 1 - well formed (normal stool, does not take the shape of the container) * Grade 2 - soft (normal stool, does not take the shape of the container) * Grade 3 - thick liquid (diarrhea, takes the shape of the container readily) * Grade 4 - opaque watery diarrhea * Grade 5 - rice water diarrhea (clear watery) The definition of diarrhea is a grade 3 or higher stool.
Time frame: Day 1 - Day 5 (up to first dose of antibiotic therapy)
Diarrheal Stool Output Rate Including Participants With Symptom Onset After 48 Hours
Stools were graded based on consistency as follows: * Grade 1 - well formed (normal stool, does not take the shape of the container) * Grade 2 - soft (normal stool, does not take the shape of the container) * Grade 3 - thick liquid (diarrhea, takes the shape of the container readily) * Grade 4 - opaque watery diarrhea * Grade 5 - rice water diarrhea (clear watery) The definition of diarrhea is a grade 3 or higher stool. For participants with symptom onset within 48 hours of challenge diarrheal stool output rate is defined as the total volume of diarrheal stools (mL, Grade 3 and above) divided by the number of hours between initiation of study product dosing and initiation of antibiotic therapy. For participants with symptom onset after 48 hours diarrheal stool output rate is defined as the total volume of diarrheal stools (mL, Grade 3 and above) divided by the number of hours between onset of symptoms and initiation of antibiotic therapy.
Time frame: Day 1 - Day 5 (up to first dose of antibiotic therapy)
Number of Participants With Treatment-emergent Serious Adverse Events
A serious adverse event (SAE) is any adverse event that resulted in any of the following outcomes: 1. Death 2. A life-threatening event. 3. Required inpatient hospitalization or prolongation of existing hospitalization 4. Resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions 5. Congenital abnormality or birth defect 6. Important medical event that may not result in one of the above outcomes but may jeopardize the health of the study participant and/or requires medical or surgical intervention to prevent one of the outcomes listed in the above definition of serious adverse event.
Time frame: Day 1 - Day 180
Percentage of Participants With Moderate to Severe Diarrhea With Onset Within 48 Hours Following Cholera Challenge
The percentage of participants with moderate to severe diarrhea with onset within 48 hours following cholera challenge. Diarrhea was defined as a grade 3 or higher stool based on the following scale: * Grade 1 - well formed (normal stool, does not take the shape of the container) * Grade 2 - soft (normal stool, does not take the shape of the container) * Grade 3 - thick liquid (diarrhea, takes the shape of the container readily) * Grade 4 - opaque watery diarrhea * Grade 5 - rice water diarrhea (clear watery) Diarrheal stools (Grade 3-5) were graded for severity according to the following: Mild: ≤ 3 liters loose stools; Moderate: \> 3 liters loose stools; Severe: \> 5 liters loose stools.
Time frame: Day 1 - Day 5 (up to first dose of antibiotic therapy)
Attack Rate of Any Diarrhea Following Cholera Challenge
Attack rate of any diarrhea following cholera challenge is defined as the number of participants with 2 or more loose stools (Grade 3-5) totaling \> 200 mL or 1 loose (Grade 3-5) stool \> 300 mL, respectively, with onset within 48 hours of cholera challenge.
Time frame: Day 1 - Day 5 (up to first dose of antibiotic therapy)
Area Under the Curve (AUC) of Diarrheal Stool Volume Between Challenge Dose and Initiation of Antibiotics
The AUC of diarrheal stool volume and cholera organisms was computed via the trapezoidal rule.
Time frame: Day 1 to Day 5 (prior to first dose of antibiotic)
Peak Shedding of Cholera Organisms
Quantitative cultures were performed on the first two stool samples of each 24-hour period prior to the initiation of antibiotics to determine the number of cholera organisms per gram of stool. Peak shedding represents the highest colony-forming unit (CFU) counts observed for each participant.
Time frame: Day 1 to Day 5 (prior to first dose of antibiotic)
Duration of Diarrheal Episodes
Duration of diarrheal episodes was calculated using Kaplan-Meier methods as the time from cholera challenge to the time of the first formed stool (Grade 1), after which all following stools were also formed.
Time frame: Day 1 to Day 5 (prior to first dose of antibiotics)
Total Number of Loose (Grade 3-5) Stools
Total number of loose stools (Grade 3 and above) per participant during the interval immediately following challenge and prior to initiation of antibiotic therapy.
Time frame: Day 1 to Day 5 (prior to first dose of antibiotic therapy)
Percentage of Participants With Fever Following Cholera Challenge
The presence of fever was defined as a body temperature of ≥ 39°C (102.1°F).
Time frame: Day 1 to Day 5, prior to first dose of antibiotics
Percentage of Participants With Vomiting Following Cholera Challenge
Time frame: Day 1 to Day 5, prior to first dose of antibiotics
Number of Participants With Solicited Adverse Effects
Solicited adverse events (AEs) include nausea, abdominal discomfort and pain, abdominal cramps, headache, malaise, anorexia, pollakiuria, micturition urgency, sinus tachycardia, increased alertness, and were collected by interview through 7 days post-challenge (Days 1-8)
Time frame: Day 1 - Day 8
Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAE)
Unsolicited AEs include any AEs reported spontaneously by the participant, observed by the study personnel during study visits or those identified during review of medical records or source documents. Investigators assigned causality of unsolicited AEs to either the study drug, cholera infection, or an alternate etiology.
Time frame: From first dose of study drug up to Day 29
A total of 47 healthy adults were enrolled at one clinical research site in the United States. Participants were confined in an inpatient isolation research ward for a duration of approximately 11 days until discharge criteria were met.
| Milestone | iOWH032 | Placebo |
|---|---|---|
| Started | 23 | 24 |
| Completed | 23 | 22 |
| Not completed | 0 | 2 |
| Withdrew: Lost to follow-up | 0 | 2 |
Diarrheal stool output rate is defined as the total volume of diarrheal stools (in mL, Grade 3 and above) divided by the number of hours between initiation of study drug (iOWH032 or placebo) and initiation of antibiotic therapy. Stools were graded based on consistency as follows: * Grade 1 - well formed (normal stool, does not take the shape of the container) * Grade 2 - soft (normal stool, does not take the shape of the container) * Grade 3 - thick liquid (diarrhea, takes the shape of the container readily) * Grade 4 - opaque watery diarrhea * Grade 5 - rice water diarrhea (clear watery) The definition of diarrhea is a grade 3 or higher stool.
| mL/hour | iOWH032 | Placebo |
|---|---|---|
| Diarrheal Stool Output Rate | 25.42 (7.2 to 65.9) | 32.57 (14.7 to 53.0) |
Stools were graded based on consistency as follows: * Grade 1 - well formed (normal stool, does not take the shape of the container) * Grade 2 - soft (normal stool, does not take the shape of the container) * Grade 3 - thick liquid (diarrhea, takes the shape of the container readily) * Grade 4 - opaque watery diarrhea * Grade 5 - rice water diarrhea (clear watery) The definition of diarrhea is a grade 3 or higher stool. For participants with symptom onset within 48 hours of challenge diarrheal stool output rate is defined as the total volume of diarrheal stools (mL, Grade 3 and above) divided by the number of hours between initiation of study product dosing and initiation of antibiotic therapy. For participants with symptom onset after 48 hours diarrheal stool output rate is defined as the total volume of diarrheal stools (mL, Grade 3 and above) divided by the number of hours between onset of symptoms and initiation of antibiotic therapy.
| mL/hour | iOWH032 | Placebo |
|---|---|---|
| Diarrheal Stool Output Rate Including Participants With Symptom Onset After 48 Hours | 25.42 (6.3 to 63.8) | 29.22 (12.5 to 49.6) |
A serious adverse event (SAE) is any adverse event that resulted in any of the following outcomes: 1. Death 2. A life-threatening event. 3. Required inpatient hospitalization or prolongation of existing hospitalization 4. Resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions 5. Congenital abnormality or birth defect 6. Important medical event that may not result in one of the above outcomes but may jeopardize the health of the study participant and/or requires medical or surgical intervention to prevent one of the outcomes listed in the above definition of serious adverse event.
| Participants | iOWH032 | Placebo |
|---|---|---|
| Number of Participants With Treatment-emergent Serious Adverse Events | 0 | 1 |
The percentage of participants with moderate to severe diarrhea with onset within 48 hours following cholera challenge. Diarrhea was defined as a grade 3 or higher stool based on the following scale: * Grade 1 - well formed (normal stool, does not take the shape of the container) * Grade 2 - soft (normal stool, does not take the shape of the container) * Grade 3 - thick liquid (diarrhea, takes the shape of the container readily) * Grade 4 - opaque watery diarrhea * Grade 5 - rice water diarrhea (clear watery) Diarrheal stools (Grade 3-5) were graded for severity according to the following: Mild: ≤ 3 liters loose stools; Moderate: \> 3 liters loose stools; Severe: \> 5 liters loose stools.
| percentage of participants | iOWH032 | Placebo |
|---|---|---|
| Percentage of Participants With Moderate to Severe Diarrhea With Onset Within 48 Hours Following Cholera Challenge | 43.8 (19.8 to 70.1) | 55.0 (31.5 to 76.9) |
Attack rate of any diarrhea following cholera challenge is defined as the number of participants with 2 or more loose stools (Grade 3-5) totaling \> 200 mL or 1 loose (Grade 3-5) stool \> 300 mL, respectively, with onset within 48 hours of cholera challenge.
| percentage of participants | iOWH032 | Placebo |
|---|---|---|
| Attack Rate of Any Diarrhea Following Cholera Challenge | 93.8 (69.8 to 99.8) | 100.0 (83.2 to 100.0) |
The AUC of diarrheal stool volume and cholera organisms was computed via the trapezoidal rule.
| liters * hours | iOWH032 | Placebo |
|---|---|---|
| Area Under the Curve (AUC) of Diarrheal Stool Volume Between Challenge Dose and Initiation of Antibiotics | 14.91 (9.3 to 20.8) | 13.80 (9.3 to 17.7) |
Quantitative cultures were performed on the first two stool samples of each 24-hour period prior to the initiation of antibiotics to determine the number of cholera organisms per gram of stool. Peak shedding represents the highest colony-forming unit (CFU) counts observed for each participant.
| CFU/g | iOWH032 | Placebo |
|---|---|---|
| Peak Shedding of Cholera Organisms | 124960186.25 ± 163145761.682 | 186793500.00 ± 304578375.607 |
Duration of diarrheal episodes was calculated using Kaplan-Meier methods as the time from cholera challenge to the time of the first formed stool (Grade 1), after which all following stools were also formed.
| hours | iOWH032 | Placebo |
|---|---|---|
| Duration of Diarrheal Episodes | 156.48 (114.1 to 217.8) | 169.68 (108.9 to 216.4) |
Total number of loose stools (Grade 3 and above) per participant during the interval immediately following challenge and prior to initiation of antibiotic therapy.
| loose stools | iOWH032 | Placebo |
|---|---|---|
| Total Number of Loose (Grade 3-5) Stools | 12.0 (5 to 15) | 10.5 (8 to 18) |
The presence of fever was defined as a body temperature of ≥ 39°C (102.1°F).
| percentage of participants | iOWH032 | Placebo |
|---|---|---|
| Percentage of Participants With Fever Following Cholera Challenge | 6.3 (0.2 to 30.2) | 5.0 (0.1 to 24.9) |
| percentage of participants | iOWH032 | Placebo |
|---|---|---|
| Percentage of Participants With Vomiting Following Cholera Challenge | 6.3 (0.2 to 30.2) | 25.0 (8.7 to 49.1) |
Solicited adverse events (AEs) include nausea, abdominal discomfort and pain, abdominal cramps, headache, malaise, anorexia, pollakiuria, micturition urgency, sinus tachycardia, increased alertness, and were collected by interview through 7 days post-challenge (Days 1-8)
| Participants | iOWH032 | Placebo |
|---|---|---|
| Any solicited adverse event | 3 | 2 |
| Abdominal discomfort | 2 | 0 |
| Headache | 1 | 0 |
| Malaise | 0 | 1 |
| Nausea | 0 | 1 |
Unsolicited AEs include any AEs reported spontaneously by the participant, observed by the study personnel during study visits or those identified during review of medical records or source documents. Investigators assigned causality of unsolicited AEs to either the study drug, cholera infection, or an alternate etiology.
| Participants | iOWH032 | Placebo |
|---|---|---|
| Any unsolicited TEAE | 18 | 21 |
| Study drug-related TEAE | 4 | 3 |
| TEAE leading to discontinuation from study | 0 | 0 |
| TEAE leading to death | 0 | 0 |
Collected over Serious adverse events and deaths were collected from first dose of study drug up to Day 180. Non-serious adverse events are reported from first dose of study drug up to Day 29.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| iOWH032 | 0/23 (0%) | 0/23 (0%) | 18/23 (78.3%) |
| Placebo | 0/24 (0%) | 1/24 (4.2%) | 21/24 (87.5%) |
| Event | iOWH032 | Placebo |
|---|---|---|
| PyelonephritisInfections and infestations | 0/23 | 1/24 |
| Event | iOWH032 | Placebo |
|---|---|---|
| HeadacheNervous system disorders | 8/23 | 9/24 |
| NauseaGastrointestinal disorders | 6/23 | 5/24 |
| Sinus tachycardiaCardiac disorders | 6/23 | 1/24 |
| VomitingGastrointestinal disorders | 1/23 | 6/24 |
| DiarrhoeaGastrointestinal disorders | 5/23 | 4/24 |
| PyrexiaGeneral disorders | 4/23 | 5/24 |
| Abdominal discomfortGastrointestinal disorders | 4/23 | 2/24 |
| ChillsGeneral disorders | 4/23 | 2/24 |
| Abdominal painGastrointestinal disorders | 2/23 | 4/24 |
| Decreased appetiteMetabolism and nutrition disorders | 3/23 | 3/24 |
All enrolled participants
| Age, Continuous(years) | iOWH032 | Placebo | Total |
|---|---|---|---|
| Mean | 32.0 ± 6.15 | 32.3 ± 5.97 | 32.1 ± 6.00 |
| Sex: Female, Male(Participants) | iOWH032 | Placebo | Total |
|---|---|---|---|
| Female | 9 | 11 | 20 |
| Male | 14 | 13 | 27 |
| Race/Ethnicity, Customized(Participants) | iOWH032 | Placebo | Total |
|---|---|---|---|
| White | 2 | 5 | 7 |
| Black or African American | 21 | 19 | 40 |
| Blood Type(Participants) | iOWH032 | Placebo | Total |
|---|---|---|---|
| Type O | 12 | 13 | 25 |
| Non-O | 11 | 11 | 22 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2019 to primary completion in Jul 2020, 8 months.
Results were first posted in Mar 2021, 7 months after primary completion.
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Studies of the drug tested here: IOWH-032