Study to Evaluate Safety, Tolerability & PK of rhNGF in Healthy Volunteers

Inclusion Criteria

To be eligible for inclusion into this study, each subject must fulfil the following inclusion criteria.Each subject must meet all of the following inclusion criteria at the pre-study Screening visit (within 20 days prior to admission in the Unit for the dosing period) in order to participate in this study.

• Male or female subjects of Japanese ethnicity, aged between 18 and 60 years inclusive, who must have all four Japanese grandparents who were born in Japan.
• Subject has to be able to communicate well with the investigator, understands and complies with the requirements of the study, and understands and signs the written volunteer informed consent form.
• Subject's systemic and ocular medical history must be considered normal in the opinion of the investigator at the Screening and Baseline visits.
• Subject with Best corrected distance visual acuity (BCDVA) score ≥83 ETDRS letters, ≤ 0.00 LogMAR [20/20 Snellen or 1.0 decimal fraction] in each eye at the Screening and Baseline visits.
• Normal anterior segment on external and slit lamp examination in both eyes at the Screening and Baseline visits.
• Normal posterior segment on fundus ophthalmoscopic examination in both eyes at the Screening and Baseline visits.
• Subject must be considered in good systemic health in the opinion of the investigator at the Screening and Baseline visits, as determined by:
• Subject's body mass index is between 18.5 and 30.4 kg/m2 inclusive
• A pre-study physical examination with no clinically significant abnormalities.
• Vital signs within clinically acceptable ranges for the purposes of the study (sitting systolic blood pressure [BP] ≥ 90 mmHg and ≤ 150 mmHg; diastolic BP ≥ 50 mmHg and ≤ 95 mmHg; heart rate ≥ 40 and ≤ 100 beats per minute; oral body temperature ≥ 35.5°C and ≤ 37.5°C).
• An ECG with no clinically significant abnormalities.
• Pre-study clinical laboratory findings within normal range or not deemed clinically significant in the opinion of the investigator if outside of the normal range
• Woman subject who meets the criteria for post-menopausal stage (post menopause is defined as the period following peri-menopause, i.e. postmenopausal after 12 months without a menstrual period and with a serum FSH value within the reference range for postmenopausal females at Screening) or permanently sterilised (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy) or woman subject using oral, injected or implanted hormonal methods of contraception or with a double barrier methods of contraception: condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository. A female condom and a male condom should not be used together as friction between the two can result in either product failing.
• Male subjects with female partners of child-bearing potential must use 2 different forms of highly effective contraception throughout the study and for a further 3 months after the follow-up visit and all male subjects must be willing to avoid donating sperm during this time. The following methods of contraception are considered to be highly effective: established use of oral, injected or implanted hormonal contraception; placement of an intrauterine device or intrauterine system; use of a barrier method of contraception (condom or occlusive cap with use of a spermicide); male sterilisation (post-vasectomy documentation of the absence of sperm in the ejaculate must be provided).

Exclusion Criteria

Subjects meeting any of the following criteria at Screening will be excluded from entry into the study:

• Subject has had a clinically significant illness in the 6 weeks before screening in the opinion of the investigator.
• Subject is not suitable to participate in the study in the opinion of the investigator
• Subject has participated in any clinical study with an investigational drug/device within 3 months prior to the first day of dosing.
• Subject has had a serious