Study of ASLAN004 in Healthy Subjects

• ClinicalTrials.gov Identifier: NCT03721263
• Recruitment Status: Completed
• First Posted: October 26, 2018
• Last Update Posted: August 5, 2020
• Sponsor: Aslan Pharmaceuticals
• Collaborator: Iqvia Pty Ltd
• Information provided by (Responsible Party): Aslan Pharmaceuticals

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
Allergic Disorder	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 (Clinical Trial)
• Actual Enrollment: 44 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Single 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: October 15, 2018
• Actual Primary Completion Date: March 27, 2019
• Actual Study Completion Date: June 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 [ 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 Outcome Measures :

1. PK parameters: Area under the curve (AUC) from time zero to the time of the last quantifiable concentration [AUC(0-last)] [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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

• Ages Eligible for Study: 21 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Singapore

CGH Clinical Trials & Research Unit

Singapore, Singapore

Sponsors and Collaborators

Aslan Pharmaceuticals

Iqvia Pty Ltd

More Information

• Responsible Party: Aslan Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT03721263
• Other Study ID Numbers: ASLAN004-001
• First Posted: October 26, 2018
• Last Update Posted: August 5, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• 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; Immune System Diseases