Study of CD388 Intramuscular or Subcutaneous Administration in Healthy Subjects

Inclusion Criteria

• Willing and able to provide written informed consent.
• Males and females 18 to 65 years of age, inclusive.
• A female subject must meet one of the following criteria:
• If of childbearing potential - agrees to use a highly effective, preferably user-independent method of contraception (failure rate of <1 percent per year when used consistently and correctly) for at least 30 days prior to screening and agrees to remain on a highly effective method until 205 days after last dose of study medication. Examples of highly-effective methods of contraception include: abstinence from heterosexual intercourse; hormonal contraceptives (birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch); intrauterine device (with or without hormones); or a double barrier method (e.g., condom and spermicide).
• If a female of non-childbearing potential - should be surgically sterile (i.e., has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation/occlusion) or in a menopausal state (at least 1 year without menses), as confirmed by follicle-stimulating hormone (FSH) levels (≥40 milli-International units [mIU]/milliliter [mL]).
• A woman of childbearing potential must have a negative highly sensitive serum pregnancy test (β-human chorionic gonadotropin) at screening and a negative urine pregnancy test on Day -1 before the first dose of study drug.
• A male subject that engages in sexual activity that has the risk of pregnancy must agree to use a double barrier method (e.g., condom and spermicide) and agree to not donate sperm during the study and until at least 205 days after the last dose of the study medication.
• Good health and without signs or symptoms of current illness.
• Normal clinical examination, including:
• No physical examination findings that an Investigator determines would interfere with interpretation of study results.
• Screening ECG without clinically significant abnormalities.
• Creatinine clearance (CrCL) ≥80 mL/minute as calculated using the Cockcroft-Gault equation.
• Negative urine screen for drugs of abuse and alcohol at screening and Day -1.
• Body mass index (BMI; weight in kilograms [kg] divided by height in meters [m] squared) between 18.0 and 32.0 kg/m^2, inclusive.
• Willing to refrain from strenuous physical activity that could cause muscle aches or injury, including contact sports, at any time from screening through 30 days after any dose of study drug.
• Subject has adequate venous access for blood collection.

Exclusion Criteria

• History of any hypersensitivity or allergic reaction to zanamivir or other neuraminidase inhibitors (i.e., laninamivir, oseltamivir, peramivir), or to excipients of the CD388 Injection drug formulation; or history of drug-induced exfoliative skin disorders (e.g., Stevens-Johnson syndrome [SJS], erythema multiforme, or toxic epidermal necrolysis [TEN]).
• History of any of the following:
• Allergies, anaphylaxis, skin rashes (foods such as milk, eggs, medications, vaccines, polyethylene glycol [PEG], etc.).
• Chronic immune-mediated disease, positive first-degree family history of autoimmune diseases.
• Atopic dermatitis or psoriasis.
• Bleeding disorder.
• Psychiatric condition, seizures, hallucinations, anxiety, depression, or treatment for mental conditions.
• Migraines.
• Syncope, or vasovagal syndrome with injections or blood draws.
• Cardiac arrhythmia.
• Subjects with one or more of the following laboratory abnormalities at screening as defined by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events v2.1 (DAIDS 2017):
• Serum creatinine, Grade ≥1 (≥1.1 × upper limit of normal [ULN])
• Pancreatic amylase or lipase, Grade ≥2 (≥1.5 × ULN)
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT), Grade ≥1 (≥1.25 × ULN)
• Total bilirubin, Grade ≥1 (≥1.1 × ULN)
• Any other toxicity Grade ≥2, except for Grade 2 elevations of t