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

NCT02342652 | Completed Phase 1 DMC

• 1 other identifier: ASLAN003-002
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Elderly Subjects (Age ≥55 Years)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

ASLAN003

EXPERIMENTAL

Substance: ASLAN003 Administration route: Oral. Dosage form: Hard gelatine 50 mg capsules. Frequency: 100 mg (2 capsules) once daily for 14 consecutive days

Drug: ASLAN003

Matched Placebo

PLACEBO COMPARATOR

Substance: Placebo Administration route: Oral Dosage form: Hard gelatine capsules Frequency: 2 capsules once daily for 14 consecutive days

Drug: Matched Placebo

Interventions

ASLAN003 DRUG

Healthy subject will be randomised to receive either ASLAN003 (N-aryl substituted aminoaryloic acid derivative), which is a DHODH inhibitor developed with the aim of improving several features of teriflunomide or the matching placebo as a negative control for each dose of ASLAN003 administered.

Also known as: LAS186323

ASLAN003

Matched Placebo DRUG

Healthy subject will be randomised to receive either ASLAN003 (N-aryl substituted aminoaryloic acid derivative), which is a DHODH inhibitor developed with the aim of improving several features of teriflunomide or the matching placebo as a negative control for each dose of ASLAN003 administered.

Matched Placebo

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 or female subjects aged between 55 years and above;
• body mass index (BMI) in the range of 18 to 27 kg/m2, inclusive;
• 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;
• whose out-of-normal range clinical laboratory test results are not clinically relevant and are acceptable to the Investigator;
• whose results are negative for hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) I and II tests at screening;
• whose results are negative for drugs of abuse and alcohol tests at screening and admission to the study centre;
• non smoker or use of \< 10 cigarettes (or equivalent nicotine-containing product) per day; (able to refrain from smoking during the study period
• 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;

You may not qualify if:

• 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;
• QTcF values higher than 450 ms at screening, unless assessed to be non-clinically significant by the Investigator or cardiologist;
• 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;
• 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;
• has donated plasma or blood or loss of more than 250 mL blood within 1 month prior to the first day of dose administration;
• is considering or has scheduled any surgical procedure during study participation;
• 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;

Sponsors & Collaborators

• ASLAN Pharmaceuticals: lead

Study Sites (1)

Unknown Facility

Singapore, Singapore

Location

Study Officials

• Please contact ASLAN Pharmaceuticals

  contact@aslanpharma.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2015
• First Posted: January 21, 2015
• Study Start: October 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: November 2, 2016

Record last verified: 2016-10

Locations

SG (1)