Study of ASLAN004 in Healthy Subjects

NCT03721263 | Completed Phase 1 DMC

• 1 other identifier: ASLAN004-001
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Disorder

Keywords

Allergic disorder

Outcome Measures

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

  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 Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

ASLAN004 Single Ascending Dose

EXPERIMENTAL

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 \[optional\]).

Biological: ASLAN004

Interventions

ASLAN004 BIOLOGICAL

Single Dose

ASLAN004 Single Ascending Dose

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• ASLAN Pharmaceuticals: lead
• Iqvia Pty Ltd: collaborator

Study Sites (1)

CGH Clinical Trials & Research Unit

Singapore, Singapore

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Ascending Dose

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: October 26, 2018
• Study Start: October 15, 2018
• Primary Completion: March 27, 2019
• Study Completion: June 20, 2019
• Last Updated: August 5, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)