A Study to Examine the Duration of Effect of PrEP-001 in Healthy Subjects Challenged With HRV-16

Inclusion Criteria

• Aged 18 to 55 years on the day of first dosing with Investigational Medicinal Product (IMP).
• In good health with no history of major medical conditions from the medical history, physical examination, and routine laboratory tests as determined by the Investigator at a screening evaluation. A subject with a history of Herpes type 1 or 2 infection may be included if there are no active lesions present and the subject is not taking active medication.
• A total body weight ≥50 kg and Body Mass Index (BMI) ≥18 kg/m2. If the BMI is more than 30 kg/m2, the subject may be included if the waist measurement is less than 102 cm (male), or less than 88 cm (female).
• The following inclusion criteria are applicable to subjects who are in a heterosexual relationship and female subjects in a female same sex relationship (i.e. the criteria do not apply to those in a male same sex relationship):
• True abstinence - when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception).

Or

• Two forms of effective contraceptive methods among (between) the couple, which are defined as:
• For males: i. Condom with spermicidal foam/gel/film/cream, sterilisation (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate. This applies only to males participating in the study).
• For females: i. Women no longer of child bearing potential (post-menopausal females are defined as having a history of amenorrhea for at least 2 years, otherwise they should have documented status as being surgically sterile or post hysterectomy. The latter applies only to female subjects participating in the study).

ii. If of childbearing potential, then acceptable forms of contraception include:

o Established (a minimum of 2 weeks prior to first dosing with IMP) use of oral, injected or implanted hormonal methods of contraception.

• Placement of an intrauterine device (IUD) or intrauterine system (IUS).
• Barrier methods of contraception or occlusive cap (diaphragm or cervical/vault caps), both with one of the following - spermicidal foam/gel/film/cream/suppository.
• The longevity of contraception is as follows: i. Male subjects must comply with agreed contraception from the first IMP dosing, and continuing until 90 days after the date of the last IMP dosing or Viral Challenge which ever happens later.

ii. Male subjects must not donate sperm following the first IMP dosing, and continuing until 90 days after the date of the last IMP dosing or Viral Challenge which ever happens later.

iii. Female subjects of childbearing potential must have a negative pregnancy test at screening and just prior to the date of first dosing with IMP and must be using contraception consisting of two forms of birth control (one of which must be a barrier method) starting from at least 14 days prior to the first IMP dosing and continuing until 90 days after the date of the last IMP dosing or Viral Challenge whichever happens later.

• An informed consent document signed and dated by the subject and the Investigator.
• Sero-suitable for the Challenge Virus.
• Subjects must be willing to comply with the protocol visit schedule including both face to face and phone visits.

Exclusion Criteria

• Subjects who have a significant history of any tobacco use at any time (total ≥10 pack year history [10 pack years is equivalent to one pack of 20 cigarettes a day for 10 years]).
• Females who:
• Are breastfeeding, or
• Have been pregnant within 6 months prior to the study, or
• Have a positive pregnancy test at any point during screening or prior to first dosing with IMP
• Any history or evidence of any clinically significant cardiovascular, dermatological (including psoriasis), gastrointestinal, endocrinological, haematological, hepatic, immunological, metabolic, urological, ne