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
Verified date | August 2020 |
Source | Aslan Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Singapore | CGH Clinical Trials & Research Unit | Singapore |
Lead Sponsor | Collaborator |
---|---|
Aslan Pharmaceuticals | Iqvia Pty Ltd |
Singapore,
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 |
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