Influenza Viral Challenge Study of CC-42344 in Healthy Participants

Cocrystal Pharma

Status and phase: Enrolling; Phase 2

Conditions: Influenza A

Treatments: Drug: Placebo; Drug: CC-42344

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06160531

CC-42344-P2-001

CPI-CST-001 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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96 participants in 3 patient groups, including a placebo group

CC-42344 Dose 1

Experimental group

Description:

Low dose group

Treatment:

Drug: CC-42344

CC-42344 Dose 2

Experimental group

Description:

High dose group

Treatment:

Drug: CC-42344

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo