Healthy Elderly Subjects (Age =55 Years) Clinical Trial
Official title:
A Phase 1, Randomised, Single Blind, Placebo Controlled, 2-Part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ASLAN003 in Healthy Elderly Subjects
| Verified date | October 2016 |
| Source | Aslan Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Singapore: Health Sciences Authority |
| Study type | Interventional |
This is a Phase 1, randomised, single-blind, placebo-controlled, 2 stage study design with 2
multiple dose cohorts of healthy elderly subjects.
The purpose of the study is to determine the safety, tolerability and pharmacokinetics of
ASLAN003 in healthy elderly male and female subjects.
| Status | Completed |
| Enrollment | 7 |
| Est. completion date | March 2015 |
| Est. primary completion date | March 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 55 Years and older |
| Eligibility |
Inclusion Criteria: 1. are capable of understanding and complying with the requirements of the study and have signed the informed consent form (ICF); 2. are able to communicate well with the Investigator, and understand and comply with the requirements of the study; 3. male or female subjects aged between 55 years and above; 4. body mass index (BMI) in the range of 18 to 27 kg/m2, inclusive; 5. healthy, as determined by pre study medical history, physical examinations, vital sign measurements, ECG (12 lead reporting RR, PR, QRS, corrected QT [QTc] using Fridericia's formulas [QTcF]) recordings with no evidence of clinically relevant medical disorders based on the opinion of the Investigator; 6. whose out-of-normal range clinical laboratory test results are not clinically relevant and are acceptable to the Investigator; 7. whose results are negative for hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) I and II tests at screening; 8. whose results are negative for drugs of abuse and alcohol tests at screening and admission to the study centre; 9. non smoker or use of < 10 cigarettes (or equivalent nicotine-containing product) per day; (able to refrain from smoking during the study period 10. male subjects must be willing to use barrier contraception during sexual intercourse, i.e. condoms, even if their partners are post-menopausal, surgically sterile or are using accepted contraceptive methods, from the first day of dose administrations until 3 months after the last dose administration; Exclusion Criteria: 1. have participated in a study involving another investigational device or drug study within 90 days prior to randomisation in this study; 2. history of drug hypersensitivity reactions or hypersensitivity to drugs chemically related to the IP; 3. history or evidence of a clinically significant disorder, condition or disease (including, but not limited to, cardiopulmonary, oncologic, autoimmune, immunogenic, renal, metabolic, haematological or psychiatric), that, in the opinion of the Investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion; 4. existence of any surgical or medical condition which, in the judgement of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the IP; 5. clinically significant history or evidence of any active or suspected bacterial, viral, fungal or parasitic infection within the 30 days prior to randomisation (e.g. common cold, viral syndrome, flu-like symptoms, etc.); 6. active or recent history (within 30 days prior to randomisation) of acute viral infection of the skin (e.g. Herpes simplex, Molluscum contagiosum); 7. active or history of psoriasis, or a first-degree relative with active or history of psoriasis; 8. known history or evidence of active or latent tuberculosis infection (e.g. positive tuberculin skin test showing induration >5 mm or positive tuberculin blood test) in absence of previous Bacillus Calmette Guerin vaccination, or recent exposure (within 6 months prior to randomisation in this study) to an individual with active tuberculosis or with intention to travel to a country with a high risk of tuberculosis during the study period (including the follow up period); 9. history of autoimmune disease including but not limited to lupus, rheumatoid arthritis, autoimmune thyroid disease and immune thrombocytopenia; 10. QTcF values higher than 450 ms at screening, unless assessed to be non-clinically significant by the Investigator or cardiologist; 11. history of regular alcohol consumption (within 6 months prior to randomisation in this study), defined as: an average weekly intake of greater than 21 units or any average daily intake of greater than 3 units. One unit is equivalent to a half pint (220 mL) of beer or 1 (25 mL) measure of spirits or 1 glass (125 mL) of wine; 12. history of drug abuse within 1 year prior to the first day of dose administration, as judged by the Investigator and/or has a positive urine drug screen for substances of abuse including marijuana, cocaine, amphetamines, opiates, phencyclidine, barbiturates, benzodiazepines, propoxyphene, methadone metabolites, and cannabinoids and tricyclin anti-depressants at screening or on admission to the study centre; 13. has donated plasma or blood or loss of more than 250 mL blood within 1 month prior to the first day of dose administration; 14. is considering or has scheduled any surgical procedure during study participation; 15. has received any type of vaccination within 30 days prior to randomisation in this study, or is planning to receive acellular, live or attenuated vaccines during the study; 16. current use or history of use of any systemic immunomodulatory /immunosuppressive therapy, including but not restricted to systemic steroids within 3 months prior to randomisation in this study; 17. requires treatment with any medication, either prescription or non-prescription, or herbal medications, within 14 days prior to the first dose of IP (exceptions are paracetamol or vitamin products at recommended daily doses); 18. administration of any prescribed or over-the-counter drug within 2 weeks prior to screening, with the exception of paracetamol, which can be used during the study; 19. current renal insufficiency ( defined as an estimated creatinine clearance of <60 mL/min as determined from the reference range of CGH laboratory report.) 20. male subjects who plan to donate sperm in the 6 months following the receipt of IP; 21. is judged by the Investigator or the Sponsor to be inappropriate for the study. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Aslan Pharmaceuticals |
Singapore,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety (12 lead ECGs, physical examination, vital signs measurements, pulse rate, RR, body temperature, clinical laboratory assessments and recording of adverse events) | Safety assessments will include 12 lead ECGs, physical examination, vital signs measurements, pulse rate, RR, body temperature, clinical laboratory assessments and recording of adverse events | 6 months | Yes |