Study of ASLAN004 in Healthy Subjects

Phase 1

Completed

• Conditions: Allergic Disorder
• Interventions: Biological: ASLAN004

• Registration Number: NCT03721263
• Lead Sponsor: ASLAN Pharmaceuticals

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-10-10
• Study Start: 2018-10-15
• Study First Submitted QC: 2018-10-22
• Study First Posted: 2018-10-26
• Primary Completion: 2019-03-27
• Study Completion: 2019-06-20
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-04
• Last Update Posted: 2020-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ASLAN004 Single Ascending Dose	ASLAN004	Up to 10 dose levels are planned. ASLAN004 by IV route: 0.1 mg/kg (Cohort 1), 0.3 mg/kg (Cohort 2), 1 mg/kg (Cohort 3), 3 mg/kg (Cohort 4) and 10 mg/kg (Cohort 5), 20 mg/kg (Cohort 6 \[optional\]). ASLAN004 SC route: 75 mg (Cohort 7), 150 mg (Cohort 8), 300 mg (Cohort 9), and 600 mg (Cohort 10 \[optional\]).

Primary Outcome Measures

Name	Time	Method
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	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 Outcome Measures

Name	Time	Method
PK parameters: Area under the curve (AUC) from time zero to the time of the last quantifiable concentration [AUC(0-last)]	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)
PK parameters: Dose-normalized Cmax (Cmax/dose)	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)
PK parameters: Estimate of volume of distribution at steady state (Vss)	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)
PK parameters: Subcutaneous bioavailability (F)	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)
PK parameters: AUC (AUC(0-inf)/dose)	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)

Trial Locations

Locations (1)

CGH Clinical Trials & Research Unit; 🇸🇬 Singapore, Singapore