Phase 3 study

Reproduced exactly, unedited. Written for researchers rather than for patients.

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

Primary Stratum A (non-immunocompromised participants who have chronic stable medical conditions) and Primary Stratum B (participants who are immunocompromised either due to underlying disease or receipt of immunosuppressive medications)

• Has negative rapid antigen tests for influenza and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) prior to dosing at Day 1
• Weight is ≥ 40 kg

Primary Stratum A only

• Has a history of pulmonary disease
• Has moderate to severe asthma, as defined by the Global Initiative for Asthma (GINA 2025)
• Has existing cardiac disease
• Has insulin-dependent diabetes
• Has moderate renal impairment
• Is ≥ 65 years of age at the time of randomization but does not meet any of the above criteria for Primary Stratum A, and is otherwise healthy

Primary Stratum B only

• Has a solid tumor diagnosis AND has received chemotherapy and/or immunotherapy within 1 year of screening

• Has a diagnosis of a hematologic malignancy within 5 years of screening AND has received any chemotherapy or biologic therapy within 1 year of screening

• Participants who have had a solid organ transplant (SOT) must satisfy all of the following:

  • Has received a kidney, liver, heart, or lung transplant more than 6 months prior to screening
  • Is currently receiving at least two immunosuppressive medications

• Participants who have had a hematopoietic stem cell transplant (HSCT) must satisfy at least one of the following:

  • Has a history of hematopoietic stem cell transplantation (HSCT) (i.e., autologous, allogeneic, bone marrow, peripheral blood stem cell, tandem [peripheral blood and marrow]) within 1 year of screening
  • Has a history of non-autologous HSCT with graft-versus-host disease (GvHD) requiring active treatment with immunosuppressants (e.g., systemic corticosteroids ≥1 mg/kg at screening), regardless of the duration of time since HSCT

• Is receiving immunosuppressive medicines

• Has received chimeric antigen receptor-modified T-cell therapy

• Has received B-cell depleting therapies (e.g., rituximab, ocrelizumab, ofatumumab, alemtuzumab) within the 12 months prior to screening

• Has a diagnosis of any primary immunodeficiency except immunoglobulin A (IgA) deficiency

• Has advanced or untreated human immunodeficiency virus (HIV) infection

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

• Known or suspected allergy or history of anaphylaxis or other serious adverse reactions to zanamivir (following administration of inhaled or intravenous formulations), monoclonal antibody (mAbs (including Fc domains)), or any of the components of CD388 or placebo
• Has an acute (time-limited) or febrile (temperature ≥ 38.0°C [≥ 100.4°F]) illness within 7 days prior to planned dosing on Day 1
• Has severe chronic kidney disease (CKD) or is receiving hemodialysis
• Receipt within the past 30 days or 5 half-lives (whichever is longer) or anticipated receipt of any drug or other biologic agent (e.g., mAbs) administered for the prevention or treatment of influenza
• Has a clinically significant bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder) or medical history of significant bleeding or bruising following intramuscular or subcutaneous (SC) injections or venipuncture
• Has previously enrolled in this study (CD388.SQ.3.06)