A Phase 1, 2-Part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ASLAN003 in Healthy Elderly Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 14 November 2016
• Main ID: NCT02342652
• Date of registration: 15/01/2015
• Prospective Registration: No
• Primary sponsor: Aslan Pharmaceuticals
• Public title: A Phase 1, 2-Part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ASLAN003 in Healthy Elderly Subjects
• Scientific 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
• Date of first enrolment: October 2014
• Target sample size: 7
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02342652
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
• Phase: Phase 1

Countries of recruitment

Singapore

Contacts

• Name: Please contact ASLAN Pharmaceuticals
• Affiliation: [e-mail]

Key inclusion & exclusion criteria

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.



Age minimum: 55 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy Elderly Subjects (Age =55 Years)

Intervention(s)

Drug: Matched Placebo

Drug: ASLAN003

Primary Outcome(s)

Safety (12 lead ECGs, physical examination, vital signs measurements, pulse rate, RR, body temperature, clinical laboratory assessments and recording of adverse events) [Time Frame: 6 months]

Secondary ID(s)

ASLAN003-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors