Influenza APhase 2NCT06160531
Influenza Viral Challenge Study of CC-42344 in Healthy Participants
A Phase 2 study testing CC-42344 in people with Influenza A, run by Cocrystal Pharma, Inc. at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza A
- What is being tested?
- CC-42344
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Nov 2023to 18 Jul 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- History of or current significant medical condition
- Upper or lower respiratory tract infection within 4 weeks
- Vaccination within 4 weeks
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen Mary BioEnterprises Innovation Centre
London, E1 2AX
About this study
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
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.
Read the 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.
- Conditions
- Influenza A
- Being tested
- CC-42344, Placebo
- Keywords
- Tolerability, Antiviral, Viral challenge model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-42344Drug
Anti-influenza A agent
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| CC-42344 Dose 1 | Experimental | Low dose group Receives: Drug: CC-42344 |
| CC-42344 Dose 2 | Experimental | High dose group Receives: Drug: CC-42344 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1 to Day 8
Secondary outcomes (13)
Maximum viral load
Determined by qRT-PCR on nasal samples
Measured: Day 1 to Day 8
Time to first confirmed nonquantifiable viral assessment
Determined by qRT-PCR on nasal samples
Measured: Day 1 to Day 8
VL-AUC of influenza challenge virus
Determined by viral culture on nasal samples
Measured: Day 1 to Day 8
Maximum viral load
Determined by viral culture on nasal samples
Measured: Day 1 to Day 8
Time to first confirmed nonquantifiable viral assessment
Determined by viral culture on nasal samples
Measured: Day 1 to Day 8
Area under the curve over time of total clinical symptoms score (TSS-AUC)
Measured: Day 1 to Day 8
Peak TSS
Measured: Day 1 to Day 8
Peak daily symptom score
Measured: Day 1 to Day 8
Time to symptom resolution
Measured: Day 1 to Day 8
Incidence of adverse events (AEs)
Number of participants with AEs
Measured: Day 1 to Day 28
Incidence of serious adverse events (SAEs)
Number of participants with SAEs
Measured: Day 1 to Day 28
Incidence of AEs related to viral challenge
Number of participants with AEs related to viral challenge
Measured: Day 1 to Day 28
Incidence of SAEs related to viral challenge
Number of participants with SAEs related to viral challenge
Measured: Day 1 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start25 Nov 2023
- Primary completion3 May 2024
- Study completion18 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza AStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cocrystal Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- hVIVO Services Limited
- Responsible party
- Sponsor
- Investigators
- Victoria Parker, MMBS, Principal investigator, hVIVO Services Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06160531
- Sponsor's protocol ID
- CC-42344-P2-001
- Other IDs
- CPI-CST-001
- Status last verified
- Jul 2025
- First submitted
- 29 Nov 2023
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06160531
- Acronym / sponsor ID
- CC-42344-P2-001
- Conditions
- Influenza A
- Keywords
- Tolerability, Antiviral, Viral challenge model
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Cocrystal Pharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- hVIVO Services Limited
- Study start
- 25 Nov 2023 (actual)
- Primary completion
- 3 May 2024 (actual)
- Study completion
- 18 Jul 2024 (actual)
- First posted
- 7 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CC-42344 Dose 1 | Experimental | Drug: CC-42344Low dose group |
| CC-42344 Dose 2 | Experimental | Drug: CC-42344High dose group |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- History of or current significant medical condition
- Upper or lower respiratory tract infection within 4 weeks
- Vaccination within 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CC-42344Anti-influenza A agent | Drug | CC-42344 Dose 1, CC-42344 Dose 2 |
| PlaceboMatching placebo | Drug | Placebo |
Primary outcome
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
13 secondary outcomes
Maximum viral load
Time frame: Day 1 to Day 8
Time to first confirmed nonquantifiable viral assessment
Time frame: Day 1 to Day 8
VL-AUC of influenza challenge virus
Time frame: Day 1 to Day 8
Maximum viral load
Time frame: Day 1 to Day 8
Time to first confirmed nonquantifiable viral assessment
Time frame: Day 1 to Day 8
Area under the curve over time of total clinical symptoms score (TSS-AUC)
Time frame: Day 1 to Day 8
Peak TSS
Time frame: Day 1 to Day 8
Peak daily symptom score
Time frame: Day 1 to Day 8
Time to symptom resolution
Time frame: Day 1 to Day 8
Incidence of adverse events (AEs)
Time frame: Day 1 to Day 28
Incidence of serious adverse events (SAEs)
Time frame: Day 1 to Day 28
Incidence of AEs related to viral challenge
Time frame: Day 1 to Day 28
Incidence of SAEs related to viral challenge
Time frame: Day 1 to Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Individual participant dataSharing planned: No
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Healthy Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victoria Parker, MMBS principal investigator
hVIVO Services Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CC-42344 in people with Influenza A, run by Cocrystal Pharma, Inc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the influenza viral load-time curve (VL-AUC) of influenza challenge virus (time frame: Day 1 to Day 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.