Safety and antiviral activity of SPX-001 against influenza
Research type
Research Study
Full title
A PHASE 1B, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PROOF-OF-CONCEPT STUDY TO EVALUATE THE EFFICACY ( ANTI-VIRAL ACTIVITY) AND SAFETY OF SPX-001 IN AN INFLUENZA CHALLENGE MODEL IN HEALTHY ADULT PARTICIPANTS
IRAS ID
1006806
Contact name
Jamie Chorlton
Contact email
Sponsor organisation
SpectrumX Medical Limited
ISRCTN Number
ISRCTN52435761
Research summary
The study is designed to provide information about the antiviral effect, safety, and tolerability of SPX-001. Results from this proof-of-concept clinical study will be useful in developing a new therapy for viral respiratory tract infections, e.g., influenza.
Up to 50 participants will be enrolled onto the study. Each participant will remain in the study for about 7 months from screening until their last follow-up visit.
The study is divided into 4 phases:
Screening phase: Screening will occur between Day -90 to Day -3/-2. Historical generic screening data collected through the hVIVO generic screening process may be transferred to this study after the study-specific consent form has been signed by the participant.
Vaccination phase: Participants will be invited to clinic to be randomly allocated to receive a single jab in the arm of dose of either: SPX-001 or placebo.
Participants will resident in the quarantine unit for approximately 11 days (from Day -2/-1 to Day 8). Procedures will include:
Admission to quarantine unit on Day -2/-1.
Baseline assessment will be conducted as per Schedule of Events (SoE) up to inoculation on Day 0.
Influenza virus inoculation on Day 0.
Randomisation.:
From Day 1 (am) to Day 7 inclusive, participants will be given 3 daily doses of SPX-001 or placebo
Quarantine phase: Participants will stay in the quarantine unit for approximately 11 days (from Day -2 to Day 8).
Final follow-up visit: Participant are invited to come in for their follow up visit on Day 28 (±3 days).REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
23/EE/0157
Date of REC Opinion
30 Nov 2023
REC opinion
Further Information Favourable Opinion