A Study of NP-011 in Healthy Volunteers

Inclusion Criteria:

1. Normal healthy volunteers with an age of 18 to 65 years inclusive at the time ofinformed consent.
2. Participants can be of any ethnicity or race, excluding Asian by self-declaration. Forthe purposes of this protocol, Asian is defined as a person having origins in any ofthe original peoples of the Far East, Southeast Asia, or the Indian subcontinent,including for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan,Philippines, Thailand, and Vietnam. If an individual identifies as mixed race,exclusion will occur if the proportion of self-declaration as Asian exceeds 25%.
3. Participants must be in good general health, in the opinion of the Investigator, withno significant medical history (ie, history of childhood asthma [resolved] isacceptable; history of depression [non-hospitalised, medicated] or migraines is notacceptable), and no clinically significant abnormalities on physical examination atScreening and/or before administration of the initial dose of IP.
4. Participants must have documented evidence of receipt of licensed COVID-19vaccinations as per the current Australian Technical Advisory Group on Immunisation (ATAGI) guidelines and be fully vaccinated as per local guidelines.
5. Participants must have a BMI between > 18.0 and < 32.0 kg/m2 at Screening.
6. Participants must have clinical laboratory values within normal range as specified bythe testing laboratory, unless deemed not clinically significant by the Investigatoror delegate. A single repeat test can be performed for clinically significant abnormalvalues, at the discretion of the Investigator.
7. Participants must be a non-smoker and must not have used any tobacco products within 2months prior to Screening, or if a smoker, they must smoke no more than 2 cigarettesor equivalent per week.
8. Participants must have no relevant dietary restrictions (restrictions that wouldprevent consumption of the standard meals to be provided), and be willing to consumestandard meals provided.
9. Females must be non-pregnant and non-lactating, and must use an acceptable, highlyeffective double contraception from Screening until 30 days after last dose of IP,including the follow-up period. Double contraception is defined as a condom AND oneother form of the following:

• Established hormonal contraception (with approved oral contraceptive pills [OCPs], long-acting implantable hormones, injectable hormones);
• A vaginal ring or an intrauterine device (IUD);
• Documented evidence of surgical sterilisation at least 6 months prior toScreening (eg, tubal occlusion, hysterectomy, bilateral salpingectomy, orbilateral oophorectomy for women or vasectomy for men, provided the male partneris a sole partner). Women not of childbearing potential must be post-menopausal for ≥ 12 months.Post-menopausal status will be confirmed through testing of follicle-stimulatinghormone (FSH) levels ≥ 40 IU/L at Screening for amenorrhoeic female participants.Females who are abstinent from heterosexual intercourse will also be eligible. Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods)and withdrawal are not considered highly effective methods of birth control.Participant complete abstinence for the duration of the study and for 1 month afterthe last study treatment is acceptable. Female participants who are in exclusively same-sex relationships are not required touse contraception. Woman of childbearing potential (WOCBP) must have a negative pregnancy test atScreening and Day 1 and be willing to have additional pregnancy tests as requiredthroughout the study. Males must be surgically sterile (> 30 days since vasectomy with no viable sperm),abstinent, or if engaged in sexual relations with a WOCBP, the participant and hispartner must be surgically sterile (eg, tubal occlusion, hysterectomy, bilateralsalpingectomy, bilateral oophorectomy) or using an acceptable, highly effectivecontraceptive method from Screening until study completion, including the follow-upperiod, and for at least 90 days post final dose. Acceptable methods of contraceptioninclude the use of condoms and the use of an effective contraceptive for the femalepartner that includes: OCPs, long-acting implantable hormones, injectable hormones, avaginal ring, or an IUD. Participants with same-sex partners (abstinence frompenile-vaginal intercourse) are eligible when this is their preferred and usuallifestyle.

10. Male participants must not donate sperm for at least 90 days after the last dose ofIP, and female participants must not donate ovum for at least 30 days after the lastdose of IP.

Exclusion Criteria:

1. Use of any IP or investigational medicinal device within 30 days prior to treatment,or 5 half-lives of the product, whichever is the longest.
2. Prior or ongoing medical conditions, medical history, physical findings, or laboratoryabnormality that, in the Investigator's opinion, could adversely affect the safety ofthe participant or confound treatment assessment.
3. Allergy or hypersensitivity to the IP or any of its constituents.
4. History of allergic or anaphylactic reactions that are considered severe in theopinion of the Investigator (with the allowance of well-managed allergies such asallergic rhinitis, eczema, stinging insect allergies, and pollen allergies).
5. Any history of cardiac disease.
6. Abnormal ECG findings at Screening that are considered by the Investigator to beclinically significant.
7. Use of or anticipated use of any prescription drugs (other than hormonalcontraception; OCPs, long-acting implantable hormones, injectable hormones, a vaginalring, or an IUD), over-the-counter (OTC) medication, herbal remedies, supplements, orvitamins 2 weeks prior to dosing and during course of study without prior approval ofthe Investigator and MM. Simple analgesics (paracetamol, nonsteroidalanti-inflammatory drugs [NSAIDs]) are permitted at 1 or 2 therapeutic doses per weekat the discretion of the Investigator.
8. Pregnant or lactating at Screening or planning to become pregnant (self or partner) atany time during the study, including the follow-up period.
9. Presence of any underlying physical or psychological medical condition that, in theopinion of the Investigator, would make it unlikely that the participant will complywith the protocol or complete the study per protocol.
10. Blood donation or significant blood loss within 60 days prior to the first IPadministration.
11. Plasma donation within 7 days prior to the first IP administration.
12. Fever (body temperature > 38°C) or symptomatic viral or bacterial infection within 2weeks prior to Screening.
13. History of malignancy, except for non-melanoma skin cancer, excised more than 2 yearsago and cervical intraepithelial neoplasia that has been successfully cured more than 5 years prior to Screening.
14. History or presence of a condition associated with significant immunosuppression (significant in the opinion of the Investigator).
15. History of life-threatening infection (eg, meningitis).