NCT06160531

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 25, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 7, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2024

Completed
Last Updated

August 5, 2025

Status Verified

July 1, 2025

Enrollment Period

5 months

First QC Date

November 29, 2023

Last Update Submit

July 31, 2025

Conditions

Influenza A

Keywords

TolerabilityAntiviralViral challenge model

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • 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

  • Maximum viral load

    Day 1 to Day 8

  • Time to first confirmed nonquantifiable viral assessment

    Day 1 to Day 8

  • +8 more secondary outcomes

Study Arms (3)

CC-42344 Dose 1

EXPERIMENTAL

Low dose group

Drug: CC-42344

CC-42344 Dose 2

EXPERIMENTAL

High dose group

Drug: CC-42344

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

CC-42344DRUG

Anti-influenza A agent

CC-42344 Dose 1CC-42344 Dose 2
PlaceboDRUG

Matching placebo

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • History of or current significant medical condition
  • Upper or lower respiratory tract infection within 4 weeks
  • Vaccination within 4 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary BioEnterprises Innovation Centre

London, E1 2AX, United Kingdom

Location

Study Officials

  • Victoria Parker, MMBS

    hVIVO Services Limited

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2023

First Posted

December 7, 2023

Study Start

November 25, 2023

Primary Completion

May 3, 2024

Study Completion

July 18, 2024

Last Updated

August 5, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)