A Study of ALG-020572 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single Doses in Healthy Volunteers and Multiple Doses in CHB Subjects

Phase 1

Terminated

• Conditions: Chronic Hepatitis B
• Interventions: Drug: Placebo; Drug: ALG-020572

• Registration Number: NCT05001022
• Lead Sponsor: Aligos Therapeutics

Brief Summary

A Randomized Study of ALG-020572 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single and Multiple Doses in Healthy Volunteers and CHB Subjects

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-06
• Study First Submitted QC: 2021-08-06
• Study First Posted: 2021-08-11
• Study Start: 2021-09-25
• Primary Completion: 2022-07-18
• Study Completion: 2022-07-18
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-21
• Last Update Posted: 2023-04-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subcutaneous injections of placebo in HV or CHB subjects, up to 7 injections over the course of up to 29 days
ALG-020572	ALG-020572	Subcutaneous injections of ALG-020572 in HV or CHB subjects, up to 7 injections over the course of up to 29 days

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	up to 120 days for Part 2	The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1

Secondary Outcome Measures

Name	Time	Method
Half-time [t1/2]	Predose (0 hours) up to 45 Days (1080 hours)	Pharmacokinetic parameters of ALG-020572 in plasma
Area under the concentration time curve [AUC]	Predose (0 hours) up to 45 Days (1080 hours)	Pharmacokinetic parameters of ALG-020572 in plasma
Maximum Plasma Concentration [Cmax]	Predose (0 hours) up to 45 Days (1080 hours)	Pharmacokinetic parameters of ALG-020572 in plasma
Minimum Plasma Concentration [Cmin]	Predose (0 hours) up to 45 Days (1080 hours)	Pharmacokinetic parameters of ALG-020572 in plasma
Change in HBsAg (reduction) from baseline through Day 120 in Multiple Dose HBV Infected Patients	Screening, Day 1, 2, 4, 8, 11, 15, 22, 29, 36, 45, 60, 90, 120
Time to maximum plasma concentration [Tmax]	Predose (0 hours) up to 45 Days (1080 hours)	Pharmacokinetic parameters of ALG-020572 in plasma

Trial Locations

Locations (3)

Auckland Clinical Studies; 🇳🇿 Auckland, New Zealand

King's College Hospital; 🇬🇧 London, United Kingdom

St George's University of London; 🇬🇧 London, United Kingdom