A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CDI-988 in Healthy Adults After Challenge With Snow Mountain Virus

Phase 2RecruitingNCT07198139

Cocrystal Pharma, Inc.40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Norovirus

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 49 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male or non-pregnant female * Aged 18 to 49 years * Good state of health * Known fucosyl transferase 2 (FUT2) secretor status Exclusion Criteria: * History of participation in any norovirus challenge or vaccine clinical trial * Receipt or planned receipt of any non-live vaccines within 7 days or live vaccines within 30 days before screening or prior to Day 28 * History of suspected norovirus gastroenteritis or chronic/recurrent gastrointestinal symptoms (e.g., diarrhea or vomiting) within 2 years prior to screening * History of diagnosed gastrointestinal malabsorption disorders, major gastrointestinal surgery, or diagnosed chronic GI conditions * Presence of moderate or severe illness, fever (≥38°C), or diarrhea/vomiting within 7 days prior to challenge * Any acute illness on Day 1 (dosing day) * Positive Day 0 stool tests for enteric pathogens * Body weight \<45 kg or BMI \<18 or \>32 kg/m² on Day 0 * Use of immunosuppressive therapy within 6 months prior to Day 0 or having any primary or secondary immunocompromising condition * Use of high-dose systemic corticosteroids (≥20 mg/day prednisolone for ≥2 weeks) or high-dose inhaled steroids for \>7 days within 6 months

Outcomes

Primary Outcomes

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

Time frame: Day 0 to Day 21

Secondary Outcomes

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

Time frame: Day 1 to Day 6

Time to symptom improvement

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.

Time frame: Day 1 to Day 6

Time to first SMV-negative stool

Determined by RT-qPCR

Time frame: Day 1 to Day 6

Area Under the Curve of SMV load

Determined by RT-qPCR

Time frame: Day 1 to Day 21

Incidence of treatment emergent adverse events

Number of participants with adverse events following first dose

Time frame: Day 0 to Day 21

Incidence of serious adverse events

Number of participants with serious adverse events

Time frame: From signing informed consent to Day 21

Maximum plasma concentration of CDI-988

Amount of CDI-988 in the blood

Time frame: 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

Time frame: 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)

Time frame: Day 0 and Day 4 pre-dose and at 2, 3, 4, 6, 8, and 12 hours

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CDI-988 in Healthy Adults After Challenge With Snow Mountain Virus

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts