Influenza Viral Challenge Study of CC-42344 in Healthy Participants

Influenza A Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06160531
• Other study ID #: CC-42344-P2-001
• Secondary ID: CPI-CST-001
• Status: Recruiting
• Phase: Phase 2
• Start date: November 25, 2023
• Est. completion date: July 2024

Study information

• Verified date: November 2023
• Source: Cocrystal Pharma, Inc.
• Contact: Hardeep Johal, BSc
• Phone: 44 (0)7442 810912
• Email: h.johal[@]hvivo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: July 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Influenza A
• Influenza, Human

Intervention

Drug:
• CC-42344
Anti-influenza A agent
• Placebo
Matching placebo

Locations

Country	Name	City	State
United Kingdom	Queen Mary BioEnterprises Innovation Centre	London

Sponsors (2)

Lead Sponsor	Collaborator
Cocrystal Pharma, Inc.	hVIVO Services Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 1 to Day 8
Secondary	Maximum viral load	Determined by qRT-PCR on nasal samples	Day 1 to Day 8
Secondary	Time to first confirmed nonquantifiable viral assessment	Determined by qRT-PCR on nasal samples	Day 1 to Day 8
Secondary	VL-AUC of influenza challenge virus	Determined by viral culture on nasal samples	Day 1 to Day 8
Secondary	Maximum viral load	Determined by viral culture on nasal samples	Day 1 to Day 8
Secondary	Time to first confirmed nonquantifiable viral assessment	Determined by viral culture on nasal samples	Day 1 to Day 8
Secondary	Area under the curve over time of total clinical symptoms score (TSS-AUC)		Day 1 to Day 8
Secondary	Peak TSS		Day 1 to Day 8
Secondary	Peak daily symptom score		Day 1 to Day 8
Secondary	Time to symptom resolution		Day 1 to Day 8
Secondary	Incidence of adverse events (AEs)	Number of participants with AEs	Day 1 to Day 28
Secondary	Incidence of serious adverse events (SAEs)	Number of participants with SAEs	Day 1 to Day 28
Secondary	Incidence of AEs related to viral challenge	Number of participants with AEs related to viral challenge	Day 1 to Day 28
Secondary	Incidence of SAEs related to viral challenge	Number of participants with SAEs related to viral challenge	Day 1 to Day 28