Study of ASLAN004 in Healthy Subjects

Aslan Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Allergic Disorder

Treatments: Biological: ASLAN004

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03721263

ASLAN004-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

ASLAN004 Single Ascending Dose

Experimental group

Description:

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 \[optional\]).

Treatment:

Biological: ASLAN004