Influenza Viral Challenge Study of CC-42344 in Healthy Participants

Cocrystal Pharma, Inc.78 enrolled

Overview

Participants in this study will be given either CC-42344 (one of two dose levels) or placebo orally for 5 days after receiving an influenza (flu) challenge virus. Participants will not know whether they are getting placebo or CC-42344. The amount of virus in nasal samples will be measured over time. Side effects and pharmacokinetics (the amount of CC-42344 in blood) will also be measured.

This is a single-center, phase 2a, randomized, double-blind, placebo-controlled study in healthy adult participants. The primary goal of this study is to assess the antiviral activity of orally administered CC-42344 in an influenza human viral challenge model, and to explore the impact of different dose levels on efficacy. In addition, the safety, tolerability, and pharmacokinetics will be assessed.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Influenza A

Interventions

CC-42344DRUG

Anti-influenza A agent

PlaceboDRUG

Matching placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy adults * Body weight ≥50 kg * Body mass index ≥18 kg/m2 and ≤35 kg/m2 * Serology results consistent with susceptibility to challenge virus infection Exclusion Criteria: * History of or current significant medical condition * Upper or lower respiratory tract infection within 4 weeks * Vaccination within 4 weeks

Locations (1)

Queen Mary BioEnterprises Innovation Centre

London, United Kingdom

Outcomes

Primary Outcomes

Area under the influenza viral load-time curve (VL-AUC) of influenza challenge virus

Determined by quantitative real time reverse transcriptase polymerase chain reaction (qRT-PCR) on nasal samples

Time frame: Day 1 to Day 8

Secondary Outcomes

Maximum viral load

Determined by qRT-PCR on nasal samples

Time frame: Day 1 to Day 8

Time to first confirmed nonquantifiable viral assessment

Determined by qRT-PCR on nasal samples

Time frame: Day 1 to Day 8

VL-AUC of influenza challenge virus

Determined by viral culture on nasal samples

Time frame: Day 1 to Day 8

Maximum viral load

Determined by viral culture on nasal samples

Time frame: Day 1 to Day 8

Time to first confirmed nonquantifiable viral assessment

Determined by viral culture on nasal samples

Time frame: Day 1 to Day 8

Area under the curve over time of total clinical symptoms score (TSS-AUC)

Time frame: Day 1 to Day 8

Peak TSS

Time frame: Day 1 to Day 8

Peak daily symptom score

Time frame: Day 1 to Day 8

Data from ClinicalTrials.gov

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