NCT03721263|CompletedPhase 1DMC
Study of ASLAN004 in Healthy Subjects
A Phase 1, Open-Label, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of ASLAN004 in Healthy Subjects
Loading search results
Sponsor study identifier
interventional
44
1 country
1
Study Start
October 15, 2018
Actual (reported)Primary Completion
March 27, 2019
Actual (reported)Study Completion
June 20, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 20, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 10, 2018
Actual (reported)October 15, 2018
Actual (reported)October 26, 2018
Actual (reported)March 27, 2019
Actual (reported)June 20, 2019
Actual (reported)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
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
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 \[optional\]).
Single Dose
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
CGH Clinical Trials & Research Unit
Singapore, Singapore
44 participants (actual enrollment reported by the registry).
First Submitted
October 10, 2018
First Posted
October 26, 2018
Study Start
October 15, 2018
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
March 27, 2019
Actual (reported)Study Completion
June 20, 2019
Actual (reported)Last Updated
August 5, 2020
Record last verified: 2020-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: