Allergic Disorder
Conditions
Keywords
Allergic disorder
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.
Interventions
BIOLOGICALASLAN004
Single Dose
Sponsors
Iqvia Pty Ltd
ASLAN Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single Ascending Dose
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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: 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: 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: 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) |
Countries
Singapore
Outcome results
None listed