| Eligibility |
Inclusion Criteria:
1. Healthy males (all parts) or healthy females (Part 3 only).
2. Aged 18 to 45 years (Parts 1 and 2) or aged 65 to 80 years (Part 3) inclusive at the
time of signing informed consent.
3. Body mass index (BMI) of 19.0 to 31.0 kg/m2, with a body weight <95 kg, as measured at
screening.
4. Willing and able to communicate and participate in the whole study.
5. Provided a written informed consent.
6. Agreed to adhere to the contraception requirements
Exclusion Criteria:
1. Subjects who had received any IMP in a clinical research study within the 90 days
prior to Day 1.
2. Subjects who were, or were immediate family members of, a study site or sponsor
employee.
3. Subjects who had previously been administered IMP in this study. Subjects who took
part in Part 1 were not permitted to take part in Part 2.
4. Evidence of recent SARS-CoV-2 symptomatic infection within the last 3 months. Subjects
who had asymptomatic, incidental, positive polymerase chain reaction (PCR) findings
could have been included if tested more than 30 days prior to screening and test
negative at screening.
5. History of any drug or alcohol abuse in the past 2 years.
6. Regular alcohol consumption in males >21 units per week and females (Part 3 only) >14
units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units =
125 mL glass of wine, depending on type).
7. A confirmed positive alcohol breath test at screening or admission.
8. Current smokers and those who had smoked within the last 6 months. A confirmed breath
carbon monoxide (CO) reading of greater than 10 ppm at screening or admission.
9. Current users of e-cigarettes and nicotine replacement products and those who had used
these products within the last 6 months.
10. Females of childbearing potential including those who were pregnant or lactating (all
female subjects must have had a negative highly sensitive urine and serum pregnancy
test). A woman was considered of childbearing potential unless she was permanently
sterile (hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) or was
postmenopausal (had no menses for 12 months without an alternative medical cause and a
serum follicle stimulating hormone [FSH] concentration =30 IU/L) at screening and
admission visit (Part 3 only).
11. Male subjects who had pregnant or lactating partners.
12. Subjects who did not have suitable veins for multiple venepunctures/cannulation as
assessed by the investigator at screening.
13. Clinically significant abnormal clinical chemistry, haematology or urinalysis as
judged by the investigator (laboratory parameters are listed in Appendix 1 of protocol
[Appendix 16.1.1.1]).
14. Confirmed positive drugs of abuse test result (drugs of abuse tests are listed in
Appendix 1 of protocol [Appendix 16.1.1.1]) at screening or admission.
15. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or
human immunodeficiency virus (HIV) antibody results.
16. Evidence of renal impairment at screening, as indicated by an estimated creatinine
clearance (CLcr) of <80 mL/min (Parts 1 and 2) or <60 mL/min (Part 3) using the
Cockcroft-Gault equation at screening.
17. History of clinically significant cardiovascular, renal, hepatic, dermatological,
chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder,
as judged by the investigator.
18. Clinically significant abnormalities on electrocardiogram (ECG) (e.g. prolonged QTc,
prolonged PR interval).
19. Serious adverse reaction or serious hypersensitivity to any drug or the formulation
excipients.
20. Presence or history of clinically significant allergy requiring treatment, as judged
by the investigator. Hay fever was allowed unless it was active.
21. Donation of blood or plasma within the previous 3 months or loss of greater than 400
mL of blood.
22. Had received blood or plasma derivatives in the 3 months preceding dosing.
23. Adherence (for whatever reason) to an abnormal diet during the 4 weeks prior to the
study, or subjects with recent significant change in body weight.
24. Subjects who were taking, or had taken, any prescribed or over-the-counter drug (other
than up to 2 g of paracetamol per day until 24 h prior to dosing and hormone
replacement therapy [HRT]) or herbal remedies or dietary supplements (including bran)
in the 14 days before IMP administration.
25. Subjects with tattoos or scars on the abdomen which could have interfered with
injection site assessments, as determined by the investigator at screening.
26. Failure to satisfy the investigator of fitness to participate for any other reason.
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