The Effectiveness of CD388 to Prevent Flu in an Influenza Challenge Model in Healthy Adults

Inclusion Criteria

• Written informed consent signed and dated by the participant and the PI/investigator obtained before any assessment is performed.
• Adult male or female aged between 18 and 55 years old, inclusive, on the day prior to signing the consent form.
• A total body weight ≥50 kilograms (kg) and body mass index (BMI) ≥18 kg/meter squared (m^2) and ≤35kg/m^2.
• In good health with no history, or current evidence, of clinically significant medical conditions, and no clinically significant test abnormalities that will interfere with participant safety, as defined by medical history, physical examination (including vital signs), electrocardiogram (ECG), and routine laboratory tests as determined by the Principal Investigator (PI)/investigator.
• Participants will have a documented medical history either prior to entering the study or following medical history review with the study physician at screening.
• The following criteria are applicable to female participants participating in the study.
• Females of childbearing potential must have a negative pregnancy test prior to enrolment.
• Females of non-childbearing potential:
• Postmenopausal females defined as amenorrhea for ≥12 months with no alternative medical cause. A high follicle-stimulating hormone (FSH) level, within appropriate postmenopausal range, may be used to confirm postmenopausal state in the absence of combined hormonal contraception or hormone replacement therapy. If there is <12 months of amenorrhea 2 FSH samples are required at least 4 to 6 weeks apart.
• Documented status as being surgically sterile (e.g., tubal ligation, hysterectomy, bilateral salpingectomy, and bilateral oophorectomy).
• The following criteria apply to female and male participants:
• Female participants of childbearing potential must use 1 form of highly effective contraception. Hormonal methods must be in place from at least 2 weeks prior to the first study visit. The contraception use must continue until 5 effective half-lives (205 days) after the last dose of investigational medicinal product (IMP). Highly effective contraception is as described below:
• Established use of hormonal methods of contraception described below (for a minimum of 30 days prior to the first study visit). When hormonal methods of contraception are used, male partners are required to use a condom with a spermicide:
• a) combined (estrogen- and progestogen containing) hormonal contraception associated with inhibition of ovulation:
• (i) oral
• (ii) intravaginal
• (iii) transdermal
• b) progestogen-only hormonal contraception associated with inhibition of ovulation:
• (i) oral
• (ii) injectable
• (iii) implantable
• Intrauterine device.
• Intrauterine hormone-releasing system.
• Bilateral tubal ligation.
• Male sterilization (with the appropriate post vasectomy documentation of the absence of sperm in the ejaculate) where the vasectomized male is the sole partner for that woman.
• True abstinence - sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the participant.
• Male participants must agree to the contraceptive requirements below at entry to quarantine and continuing until 5 effective half-lives (205 days) after the last dose of IMP.
• Use a condom with a spermicide to prevent pregnancy in a female partner or to prevent exposure of any partner (male or female) to the IMP.
• Male sterilization with the appropriate post vasectomy documentation of the absence of sperm in the ejaculate (please note that the use of condom with spermicide will still be required to prevent partner exposure). This applies only to males participating in the study.
• In addition, for female partners of childbear