ClinicaliQ Trial Snapshot
- A Study to Evaluate the Safety and Efficacy of CD388 for Prevention of Influenza — Recruiting • Phase III • Respiratory / COPD / Asthma • NCT07159763.
- What is being tested: CD388 is a novel therapeutic agent administered as a single dose via 3 subcutaneous injections, being evaluated for its efficacy and safety in preventing symptomatic laboratory-confirmed influenza infections compared to placebo in adult and adolescent participants.
- Patient eligibility overview: The trial enrolls adult and adolescent participants (specific age criteria and additional eligibility requirements apply), representing a broad population at risk of influenza infection who would benefit from preventative interventions.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
The purpose of this study is to evaluate how well CD388 works in preventing symptomatic laboratory-confirmed influenza infections, as compared to placebo, when given as a single dose via 3 subcutaneous (SQ) injections to adult and adolescent participants who are at higher risk of developing influenza complications, and to evaluate the safety and tolerability of CD388, as compared to placebo.
Eligibility Snapshot
- : 1. Must be 12 years of age or older at the time of signing the informed consent. 2. Written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA] in the US) obtained from the participant before performing any protocol-related procedures, including screening evaluations. For participants under the legal age of consent as defined by local regulations, the parent(s) or legal guardian(s) may be required to give their signed written informed consent and participants may sign an assent form as specified by local law. 3. Has negative rapid antigen tests for influenza and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) prior to dosing at Day 1. 4. Weight is ≥ 40 kilograms (kg) at screening. 5. Body Mass Index (BMI; calculated as weight in kg divided by height in meters [m] squared)) is ≥ 18 kg/m^2 at screening. 6. In the opinion of the Investigator, must be able to comply with the requirements of the protocol and be able to read, understand, and complete questionnaires in the electronic diary (eDiary), work with smartphones/tablets/computers (if applicable, with assistance by a caregiver, surrogate, or legally authorized representative), and be willing and able to adhere to…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.