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Completed

NCT Number: NCT03721263

Study of ASLAN004 in Healthy Subjects

This is an open-label, two-part, single-center, first in human (FIH), single ascending dose (SAD) study to assess the effects of single doses of ASLAN004 when administered to healthy subjects. The objective of this study is to evaluate the safety, tolerability, and Pharmacokinetics (PK) of ASLAN004 in healthy subjects.

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Key information

Conditions

Allergic Disorder Hypersensitivity Immune System Diseases

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CGH Clinical Trials & Research Unit

Singapore

About this study

The plan is to enroll between 38 to 50 subjects at 1 study center.

The study is divided into 2 parts:

Part A is designed as a SAD study using intravenous (IV) administration of ASLAN004, as a single mg/kg IV dose and will consist of up to 6 IV cohorts.

Part B is designed as a parallel SAD study using subcutaneous (SC) administration of ASLAN004, as a single fixed milligram SC dose and will consist of up to 4 SC cohorts.

All cohorts will have sentinel dosing with the first subject of each cohort being spaced with adequate observation time of 24 to 48 hours before dosing the remaining subjects in the cohort.

All subjects would be follow up for up to 85 days from the last dosing day.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be able to sign informed consent form
  • Male and female subjects who are of legal age
  • Healthy, BMI 18.5 to 30 kg/m2
  • Normal or clinically acceptable clinical laboratory value and ECG results

Exclusion criteria

  • History of hypersensitivity reaction
  • Have food and/or topical allergies
  • Have recent history of conjunctivitis
  • Have active or history of psoriasis

Treatment and study plan

ASLAN004

Biological

Single Dose

Primary outcomes

  1. Evaluation of product safety by assessing the incidence of treatment-emergent adverse events following single ascending dose administration in healthy volunteers at Day 1 until study completion

    Time frame: 85 days

    To evaluate the safety of the product by assessing its impact on the healthy volunteer following single dose administration through review of adverse event listings

Secondary outcomes

  1. PK parameters: Area under the curve (AUC) from time zero to the time of the last quantifiable concentration [AUC(0-last)]

    Time frame: Predose,1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 72 hour, 168 hour, 240 hour and up to 3 months

    To assess the pharmacokinetics of ASLAN004 in healthy volunteers following single dose administration via IV or SC route (16 timepoints)

  2. PK parameters: Estimate of volume of distribution at steady state (Vss)

    Time frame: Predose,1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 72 hour, 168 hour, 240 hour and up to 3 months

    To assess the pharmacokinetics of ASLAN004 in healthy volunteers following single dose administration via IV or SC route (16 timepoints)

  3. PK parameters: Subcutaneous bioavailability (F)

    Time frame: Predose,1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 72 hour, 168 hour, 240 hour and up to 3 months

    To assess the pharmacokinetics of ASLAN004 in healthy volunteers following single dose administration via SC route only (16 timepoints)

  4. PK parameters: Dose-normalized Cmax (Cmax/dose)

    Time frame: Predose,1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 72 hour, 168 hour, 240 hour and up to 3 months

    To assess the pharmacokinetics of ASLAN004 in healthy volunteers following single dose administration via IV or SC route (16 timepoints)

  5. PK parameters: AUC (AUC(0-inf)/dose)

    Time frame: Predose,1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 72 hour, 168 hour, 240 hour and up to 3 months

    To assess the pharmacokinetics of ASLAN004 in healthy volunteers following single dose administration via IV or SC route (16 timepoints)

Sponsors and collaborators

Lead sponsor

ASLAN Pharmaceuticals

Other

Collaborators

  • IQVIA Pty Ltd

Registry information

Official study title

A Phase 1, Open-Label, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of ASLAN004 in Healthy Subjects

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 26, 2018
Registry last updated
Aug 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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