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Study of ASLAN004 in Healthy Subjects

Sponsor
Aslan Pharmaceuticals (Other)
Overall Status
Completed
CT.gov ID
NCT03721263
Collaborator
Iqvia Pty Ltd (Industry)
44
Enrollment
1
Location
1
Arm
8.1
Actual Duration (Months)
5.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: ASLAN004
 Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Single Ascending DoseSingle Ascending Dose
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Open-Label, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of ASLAN004 in Healthy Subjects
Actual Study Start Date :
Oct 15, 2018
Actual Primary Completion Date :
Mar 27, 2019
Actual Study Completion Date :
Jun 20, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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]).

Biological: ASLAN004
Single Dose

Outcome Measures

Primary Outcome Measures

  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 [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 Outcome Measures

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 65 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CGH Clinical Trials & Research Unit Singapore Singapore

Sponsors and Collaborators

  • Aslan Pharmaceuticals
  • Iqvia Pty Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aslan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT03721263
Other Study ID Numbers:
  • ASLAN004-001
First Posted:
Oct 26, 2018
Last Update Posted:
Aug 5, 2020
Last Verified:
Aug 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Aslan Pharmaceuticals
Allergic disorder
Additional relevant MeSH terms:
Hypersensitivity

Study Results

No Results Posted as of Aug 5, 2020