A Phase 1, Open-Label, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of ASLAN004 in Healthy Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- ASLAN Pharmaceuticals
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
ASLAN004 Single Ascending Dose
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]).
Intervention: ASLAN004 (Biological)
Outcomes
Primary Outcomes
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
- 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: 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: 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: 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)