A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 Injection for Subcutaneous Use in Healthy and Obese Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Gannex Pharma Co., Ltd.
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Study Overview
Brief Summary
This will be a phase I, randomized, double-blind, placebo-controlled, single dose escalation study. This study will be conducted in three periods: the screening period, the treatment period, and the follow-up period.
This study aims to evaluate the pharmacokinetics and target engagement of ASC47 in healthy and obese subjects.
Detailed Description
The study will consist of 8 cohorts, each with different doses of ASC47.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
SAD in healthy subjects-Cohort 1
SAD cohort 1, dose 1
Intervention: ASC47 (Drug)
SAD in healthy subjects-Cohort 1
SAD cohort 1, dose 1
Intervention: Matching placebo (Drug)
SAD in healthy subjects-Cohort 2
SAD Cohort 2, dose 2
Intervention: ASC47 (Drug)
SAD in healthy subjects-Cohort 2
SAD Cohort 2, dose 2
Intervention: Matching placebo (Drug)
SAD in healthy subjects-Cohort 3
SAD Cohort 3, dose 3
Intervention: ASC47 (Drug)
SAD in healthy subjects-Cohort 3
SAD Cohort 3, dose 3
Intervention: Matching placebo (Drug)
SAD in patients with obesity-Cohort 3A
SAD Cohort 3A, dose 3
Intervention: ASC47 (Drug)
SAD in patients with obesity-Cohort 3A
SAD Cohort 3A, dose 3
Intervention: Matching placebo (Drug)
Outcomes
Primary Outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame: up to 57 days
Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs) from after the first dose administration to 57 days.
ECG QT Interval
Time Frame: up to 57 days
Evaluate the ECG QT Interval after single doses of ASC47.
Hematology
Time Frame: up to 57 days
Evaluate the levels of glucose, cholesterol, electrolytes after single doses of ASC47.
Blood cell
Time Frame: up to 57 days
Evaluate red blood cell count, white blood cell count and platelet count in liter (cells/L) after single doses of ASC47.
Secondary Outcomes
- Cmin of ASC47(up to 57 days)
- Cmax of ASC47(up to 57 days)
- CL/F of ASC47(up to 57 days)
- T1/2 of ASC47(up to 57 days)
- Lipid parameters(up to 57 days)
- AUC of ASC47(up to 57 days)
- Vd/F of ASC47(up to 57 days)