Healthy Volunteers
Conditions
Brief summary
This is a single-centre, placebo-controlled, randomised, double-blind study to evaluate the safety and tolerability of single ascending doses (SAD) and multiple ascending doses (MAD) of ASLAN003 in healthy subjects
Detailed description
This is a single-centre, placebo-controlled, randomised, double-blind study involving SAD and MAD of ASLAN003 in healthy subjects. The study is divided into two parts: * Part A: SAD cohorts and 1 cohort to assess food effect of ASLAN003 PK. * Part B: MAD cohorts with one cohort being of healthy elderly subjects. There will be a sentinel pair of subjects for each of SAD Cohorts 1, 2 and 3 who will be dosed first and then the same dose will be given to the rest of the subjects in the respective cohorts. In addition, 8 subjects will receive ASLAN003 under both fed and fasted conditions
Interventions
DRUGASLAN003 ACTIVE
This is a single-centre, placebo-controlled, randomised, double-blind study involving SAD and MAD of ASLAN003 in healthy subjects.
Sponsors
ASLAN Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
21 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* The inclusion criteria for all subjects are as follows: * are capable of understanding and complying with the requirements of the study and have signed the informed consent form (ICF); * are able to communicate well with the Investigator, and understand and comply with the requirements of the study; * male subjects aged between 21 and 50 years, inclusive (Part A and Cohorts 5, 6 and 7 of Part B only); male subjects and female subjects of non childbearing potential aged ≥55 years (Cohort 8 of Part B only); * body mass index (BMI) in the range of 18 to 30 kg/m2, inclusive; * healthy, as determined by pre study medical history, physical examinations, vital sign measurements, electrocardiogram (ECG; 12 lead reporting RR, PR, QRS, corrected QT \[QTc\] and QT interval corrected for heart rate using Fridericia's formulas \[QTcF\]) recordings with no evidence of clinically relevant medical disorders based on the opinion of the Investigator; * whose out-of-normal range clinical laboratory test results are not clinically relevant and are acceptable to the Investigator; * 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
* The
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 6 months | Safety assessments will include 12 lead ECGs, physical examiniation, vital signs measurements, pulse rate, RR, body temperature, clinical laboratory assessments and recording of adverse events |
Countries
Singapore
Outcome results
None listed