Study of ASLAN004 in Healthy Subjects

Allergic Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03721263
• Other study ID #: ASLAN004-001
• Status: Completed
• Phase: Phase 1
• Start date: October 15, 2018
• Est. completion date: June 20, 2019

Study information

• Verified date: August 2020
• Source: Aslan Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 20, 2019
• Est. primary completion date: March 27, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Must be able to sign informed consent form

2. Male and female subjects who are of legal age

3. Healthy, BMI 18.5 to 30 kg/m2

4. Normal or clinically acceptable clinical laboratory value and ECG results

Exclusion Criteria:

1. History of hypersensitivity reaction

2. Have food and/or topical allergies

3. Have recent history of conjunctivitis

4. Have active or history of psoriasis

Related Conditions & MeSH terms

• Allergic Disorder
• Hypersensitivity

Intervention

Biological:
• ASLAN004
Single Dose

Locations

Country	Name	City	State
Singapore	CGH Clinical Trials & Research Unit	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Aslan Pharmaceuticals	Iqvia Pty Ltd

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	85 days
Secondary	PK parameters: Area under the curve (AUC) from time zero to the time of the last quantifiable concentration [AUC(0-last)]	To assess the pharmacokinetics of ASLAN004 in healthy volunteers following single dose administration via IV or SC route (16 timepoints)	Predose,1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 72 hour, 168 hour, 240 hour and up to 3 months
Secondary	PK parameters: Estimate of volume of distribution at steady state (Vss)	To assess the pharmacokinetics of ASLAN004 in healthy volunteers following single dose administration via IV or SC route (16 timepoints)	Predose,1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 72 hour, 168 hour, 240 hour and up to 3 months
Secondary	PK parameters: Subcutaneous bioavailability (F)	To assess the pharmacokinetics of ASLAN004 in healthy volunteers following single dose administration via SC route only (16 timepoints)	Predose,1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 72 hour, 168 hour, 240 hour and up to 3 months
Secondary	PK parameters: Dose-normalized Cmax (Cmax/dose)	To assess the pharmacokinetics of ASLAN004 in healthy volunteers following single dose administration via IV or SC route (16 timepoints)	Predose,1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 72 hour, 168 hour, 240 hour and up to 3 months
Secondary	PK parameters: AUC (AUC(0-inf)/dose)	To assess the pharmacokinetics of ASLAN004 in healthy volunteers following single dose administration via IV or SC route (16 timepoints)	Predose,1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 72 hour, 168 hour, 240 hour and up to 3 months