ANCHOR Study(CD388.SQ.3.06)

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of CD388, a Novel Long-Acting Antiviral Conjugate, for the Prevention of Influenza in Adults and Adolescents at Higher Risk of Developing Influenza Complications.

Rationale

Influenza can cause serious illness and complications, particularly among people who are at increased risk because of age, underlying medical conditions or immunocompromised status. The ANCHOR Study is designed to evaluate CD388 in a real-world influenza season, providing an opportunity to assess whether a long-acting antiviral approach can prevent symptomatic influenza infection following a single dose.

Primary Objective

The primary objective is to evaluate the clinical efficacy of CD388 in preventing symptomatic, laboratory-confirmed influenza infection compared with placebo.

Secondary Objectives

The study will:

• Evaluate the safety and tolerability of CD388 compared with placebo.
• Assess the pharmacokinetics of CD388 in plasma.
• Evaluate the development of anti-drug antibodies among participants receiving CD388.

Investigators

Dr Jeanne Coetzee – Principal Investigator
Prof Lee Fairlie – Sub-Investigator
Dr Faeezah Patel – Sub-Investigator
Dr Elizea Horne – Sub-Investigator
Dr Mrinmayee Dhar – Sub-Investigator
Tiffany Deborah Seef – Clinical Associate
Karabo Busisiwe Tloubatla – Clinical Associate

Latest Updated: March 2026

For more details, please email rhicomms@wrhi.ac.za