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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Cocrystal Pharma, Inc.
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Area under the influenza viral load-time curve (VL-AUC) of influenza challenge virus
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
CC-42344 Dose 1
Low dose group
Intervention: CC-42344 (Drug)
CC-42344 Dose 2
High dose group
Intervention: CC-42344 (Drug)
Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Area under the influenza viral load-time curve (VL-AUC) of influenza challenge virus
Time Frame: Day 1 to Day 8
Determined by quantitative real time reverse transcriptase polymerase chain reaction (qRT-PCR) on nasal samples
Secondary Outcomes
- Maximum viral load(Day 1 to Day 8)
- Time to first confirmed nonquantifiable viral assessment(Day 1 to Day 8)
- VL-AUC of influenza challenge virus(Day 1 to Day 8)
- Area under the curve over time of total clinical symptoms score (TSS-AUC)(Day 1 to Day 8)
- Peak TSS(Day 1 to Day 8)
- Peak daily symptom score(Day 1 to Day 8)
- Time to symptom resolution(Day 1 to Day 8)
- Incidence of adverse events (AEs)(Day 1 to Day 28)
- Incidence of serious adverse events (SAEs)(Day 1 to Day 28)
- Incidence of AEs related to viral challenge(Day 1 to Day 28)
- Incidence of SAEs related to viral challenge(Day 1 to Day 28)