The trial is taking place at:
H

hVIVO Services Limited | Queen Mary BioEnterprises Innovation Centre

Veeva-enabled site

Influenza Viral Challenge Study of CC-42344 in Healthy Participants

C

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

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

Trial contacts and locations

1

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Central trial contact

Hardeep Johal, BSc

Data sourced from clinicaltrials.gov

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