A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CDI-988 in Healthy Adults After Challenge With Snow Mountain Virus
NCT07198139 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-02-17
Summary
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.
Conditions
Interventions
- DRUG
-
CDI-988
Antiviral to treat norovirus
- DRUG
-
Matching placebo
- OTHER
-
Snow Mountain Virus
Challenge with Snow Mountain Virus
Sponsors & Collaborators
-
Cocrystal Pharma, Inc.
lead INDUSTRY
Principal Investigators
-
Nadine Rouphael, MD · Hope Clinic of the Emory Vaccine Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 49 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-03-01
- Primary Completion
- 2026-10-01
- Completion
- 2026-12-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Study to Evaluate Safety, Tolerability and Pharmacokinetics of IDB-011
NCT06925919 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Safety and Immunogenicity of AdCOVID in Healthy Adults (COVID-19 Vaccine Study)
NCT04679909 ·Status: COMPLETED ·Phase: PHASE1
-
Phase 1 Norwalk Vaccine Study
NCT00806962 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of LY3832479 (LY-CoV016) in Healthy Participants
NCT04441931 ·Status: COMPLETED ·Phase: PHASE1
-
The Safety and Tolerability of MY-586 COVID-19 Neutralizing Antibody Nasal Spray in Healthy Subjects
NCT05977101 ·Status: UNKNOWN ·Phase: NA
-
Safety, Tolerability and Pharmacokinetics of Inhaled Nanoparticle Formulation of Remdesivir (GS-5734) and NA-831
NCT04480333 ·Status: UNKNOWN ·Phase: PHASE1
-
Phase 1, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of an Enterovirus D68-specific Monoclonal Antibody in Healthy Adults
NCT06444048 ·Status: COMPLETED ·Phase: PHASE1
-
A Double-Blind Placebo Controlled Study To Determine the Optimal Immunopharmacological Dose Level of Isoprinosine in Immunodepressed Volunteers
NCT00002059 ·Status: COMPLETED ·Phase: NA
-
A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD0914
NCT01929629 ·Status: COMPLETED ·Phase: PHASE1
-
Study To Assess Local Tolerability of Crisaborole 2% Ointment and Vehicle Ointment In Healthy Participants Using Subject-reported Assessments and Objective Measurements
NCT03760042 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Immunogenicity and Safety of a Recombinant Protein COVID-19 Vaccine SCTV01E-1 in Population Aged Above 18 Years
NCT05522829 ·Status: UNKNOWN ·Phase: PHASE2
-
The Safety, Tolerability and Immunogenicity of COVID-19 Vaccine (SCTV01C) in Healthy, Unvaccinated Adults
NCT05148091 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
ABNCoV2 Vaccine in Adult Subjects Previously Vaccinated for SARS-CoV-2
NCT05329220 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Efficacy and Safety of DXP604 in Patients With Mild to Moderate COVID-19
NCT05381519 ·Status: UNKNOWN ·Phase: PHASE2
-
LY3819253 (LY-CoV555) for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)
NCT05780268 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase 2b/3, Randomized, Observer-Blinded, Placebo-Controlled, Multicenter Clinical Study Evaluating the Efficacy and Safety of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and Older
NCT04652102 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Norwalk Vaccine Study
NCT00973284 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Phase I/II Trial of Povidone-iodine (PVP-I) Nasal Swab For Preventing COVID-19 Spread in Healthy Subjects
NCT04510402 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
Phase I Clinical Study of Recombinant Novel Coronavirus Vaccine
NCT04445194 ·Status: UNKNOWN ·Phase: PHASE1
-
Efficacy and Safety of NVX-CoV2705
NCT07086222 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE4
-
Study to Evaluate the Safety and Efficacy of a Monoclonal Antibody Cocktail for the Prevention of COVID-19
NCT05142527 ·Status: WITHDRAWN ·Phase: PHASE2/PHASE3
-
Bivalent Norovirus Vaccine Study
NCT01168401 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Learn About Effects of Living With COVID-19 and the Use of the Medicines Nirmatrelvir-Ritonavir in Treating COVID-19.
NCT06085924 ·Status: COMPLETED
-
Safety and Immunogenicity of COVID-19 Vaccine, AdCLD-CoV19-1
NCT05520970 ·Status: TERMINATED ·Phase: PHASE2
-
A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897 in Healthy Adults
NCT02114268 ·Status: COMPLETED ·Phase: PHASE1