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Participants in this study will be given either CDI-988 or placebo orally before receiving a norovirus challenge virus and continuing for 5 days. Participants will not know whether they are getting placebo or CDI-988. The study will evaluate how well CDI-988 compared to placebo can reduce the incidence of clinical symptoms after a challenge with norovirus. The amount of virus in stool samples will be measured over time. Side effects and pharmacokinetics (the amount of CDI-988 in blood) will also be measured.
This is a single center Phase 1b randomized, double-blind, placebo-controlled study. The primary objective will be to evaluate the efficacy of CDI-988 in comparison to placebo in reducing the incidence of clinical symptoms after challenge with norovirus. Secondary objectives will be to evaluate the efficacy of CDI-988 in comparison to placebo in reducing viral shedding and disease severity and to evaluate the safety of CDI-988 in comparison to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Snow Mountain Virus | Other | Challenge with Snow Mountain Virus |
|
| Stage 2: Drug CDI-988 | Experimental |
| |
| Stage 2: Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CDI-988 | Drug | Antiviral to treat norovirus |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of norovirus-confirmed disease | Disease is defined as diarrhea and/or vomiting (during the inpatient period), with laboratory-confirmed infection (with SMV specific primers on stool/emesis) or seroconversion | Day 0 to Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Vesikari Score (MVS) symptom scores during the inpatient period in infected patients | Score based on duration of diarrhea, maximum number of stools in a 24 hour period, duration of vomiting and maximum number of vomiting episodes in a 24 hour period | Day 1 to Day 6 |
| Time to symptom improvement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Huang, MD, PhD | Contact | 936-577-5770 | dhuang@cocrystalpharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Nadine Rouphael, MD | Hope Clinic of the Emory Vaccine Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hope Clinic of the Emory Vaccine Center | Recruiting | Decatur | Georgia | 30030 | United States |
Only aggregate participant data will be available from this study
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| Drug |
Matching placebo |
|
| Snow Mountain Virus | Other | Challenge with Snow Mountain Virus |
|
From peak Total Symptom Score to point where Total Symptom Score is within 3 points of baseline prior to challenge. The Modified Vesikari Score is a clinical tool used to assess the severity of acute gastroenteritis in children. The minimum and maximum values are 0 and 20, respectively. Higher scores mean a worse clinical severity. For example, a higher score reflects more severe symptoms such as longer duration or higher frequency of diarrhea or vomiting. |
| Day 1 to Day 6 |
| Time to first SMV-negative stool | Determined by RT-qPCR | Day 1 to Day 6 |
| Area Under the Curve of SMV load | Determined by RT-qPCR | Day 1 to Day 21 |
| Incidence of treatment emergent adverse events | Number of participants with adverse events following first dose | Day 0 to Day 21 |
| Incidence of serious adverse events | Number of participants with serious adverse events | From signing informed consent to Day 21 |
| Maximum plasma concentration of CDI-988 | Amount of CDI-988 in the blood | Day 0 and Day 4 pre-dose and at 2, 3, 4, 6, 8, and 12 hours |
| Time of maximum plasma concentration of CDI-988 | time to reach maximum plasma concentration | Day 0 and Day 4 pre-dose and at 2, 3, 4, 6, 8, and 12 hours |
| Area under the plasma concentration time curve | Measurement of area under the plasma concentration-time curve (AUC) | Day 0 and Day 4 pre-dose and at 2, 3, 4, 6, 8, and 12 hours |