Clinical trial NCT06160531: Influenza Viral Challenge Study of CC-42344 in Healthy Participants
Official title: Randomised, Phase 2a, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity Against Influenza Infection, Safety, Tolerability, and Pharmacokinetics of CC-42344 Via a Human Viral Challenge Model in Healthy Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Influenza A
Keywords: Tolerability
Antiviral
Viral challenge model
Lead sponsor: Cocrystal Pharma, Inc.
Sponsor class: INDUSTRY
Collaborators: name: hVIVO Services Limited
First posted: 2023-12-07
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Area under the influenza viral load-time curve (VL-AUC) of influenza challenge virus
timeFrame: Day 1 to Day 8
Secondary outcomes:
measure: Maximum viral load
timeFrame: Day 1 to Day 8
measure: Time to first confirmed nonquantifiable viral assessment
timeFrame: Day 1 to Day 8
measure: VL-AUC of influenza challenge virus
timeFrame: Day 1 to Day 8
measure: Maximum viral load
timeFrame: Day 1 to Day 8
measure: Time to first confirmed nonquantifiable viral assessment
timeFrame: Day 1 to Day 8
measure: Area under the curve over time of total clinical symptoms score (TSS-AUC)
timeFrame: Day 1 to Day 8
measure: Peak TSS
timeFrame: Day 1 to Day 8
measure: Peak daily symptom score
timeFrame: Day 1 to Day 8
measure: Time to symptom resolution
timeFrame: Day 1 to Day 8
measure: Incidence of adverse events (AEs)
timeFrame: Day 1 to Day 28
measure: Incidence of serious adverse events (SAEs)
timeFrame: Day 1 to Day 28
measure: Incidence of AEs related to viral challenge
timeFrame: Day 1 to Day 28
measure: Incidence of SAEs related to viral challenge
timeFrame: Day 1 to Day 28
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Queen Mary BioEnterprises Innovation Centre
Study officials:
affiliation: hVIVO Services Limited
name: Victoria Parker, MMBS
role: PRINCIPAL_INVESTIGATOR
References: