Phase 1, Randomised Double Blinded Placebo Controlled Study of ASLAN003

Healthy Volunteers Clinical Trial

Official title:

A Phase 1, Randomised, Double Blind, Placebo Controlled, 2-Part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses and Multiple Ascending Doses of ASLAN003 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01992367
• Other study ID #: ASLAN003-001
• Status: Completed
• Phase: Phase 1
• First received: November 13, 2013
• Last updated: October 31, 2016
• Start date: August 2013
• Est. completion date: May 2014

Study information

• Verified date: October 2016
• Source: Aslan Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 99 Years

Eligibility

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 exclusion criteria for all subjects are as follows:

• have participated in a study involving another investigational device or drug study within 90 days prior to randomisation in this study;

• history of drug hypersensitivity reactions or hypersensitivity to drugs chemically related to the IP;

• 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;

• 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;

• 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.);

• active or recent history (within 30 days prior to randomisation) of acute viral infection of the skin (e.g. Herpes simplex, Molluscum contagiosum);

• active or history of psoriasis, or a first-degree relative with active or history of psoriasis;

• 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);

• history of autoimmune disease including but not limited to lupus, rheumatoid arthritis, autoimmune thyroid disease and immune thrombocytopenia;

• with QT or QTcF values higher than 450 ms at screening;

• 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;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• ASLAN003 ACTIVE
This is a single-centre, placebo-controlled, randomised, double-blind study involving SAD and MAD of ASLAN003 in healthy subjects.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aslan Pharmaceuticals

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	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	6 months	Yes