A Study of ALG-000184 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single and Multiple Doses in Healthy Volunteers and CHB Subjects

Phase 1

Recruiting

• Conditions: Chronic Hepatitis B
• Interventions: Drug: ALG-000184; Drug: Placebo; Drug: Entecavir

• Registration Number: NCT04536337
• Lead Sponsor: Aligos Therapeutics

Brief Summary

A Randomized Study of ALG-000184 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single and Multiple Doses in Healthy Volunteers and CHB Subjects

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-08-28
• Study First Submitted QC: 2020-08-28
• Study First Posted: 2020-09-02
• Study Start: 2020-10-22
• Status Verified: 2022-11
• Last Update Submitted: 2023-04-27
• Last Update Posted: 2023-04-28
• Primary Completion: 2023-11-24
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 336

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Entecavir in combination with ALG-000184	Entecavir	-
ALG-000184	ALG-000184	Oral tablet(s) of ALG-000184 in HV or CHB subjects once daily for up to 4 weeks
Entecavir in combination with ALG-000184	ALG-000184	-
Placebo	Placebo	Oral tablet(s) of placebo in HV or CHB subjects once daily for up to 4 weeks

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Up to 336 days for parts 4 & 5	The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1 of ALG-184 in combination with Entecavir (Parts 4 and 5)

Secondary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration [Cmax]	Predose up to 343 Days	Pharmacokinetic parameters of ALG-000184 in plasma
Area under the concentration time curve [AUC]	Predose up to 343 Days	Pharmacokinetic parameters of ALG-000184 in plasma
Time to maximum plasma concentration [Tmax]	Predose up to 343 Days	pharmacokinetic parameters of ALG-000184 in plasma
Half-time [t1/2]	Predose up to 343 Days	Pharmacokinetic parameters of ALG-000184 in plasma
Minimum Plasma Concentration [Cmin]	Predose up to 343 Days	Pharmacokinetic parameters of ALG-000184 in plasma
Change in HBV DNA from baseline through Day 392 in Multiple Dose HBV Infected Patients	Screening up to Day 392

Trial Locations

Locations (12)

Saint Vincent's Hospital Melbourne; 🇦🇺 Fitzroy, Victoria, Australia

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

The Second Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China

The First Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China

ACS; 🇳🇿 Auckland, New Zealand

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

Nanfang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China

CAP Research; 🇲🇺 Quatre Bornes, Mauritius

PMSI Republican Clinical Hospital "T. Mosneaga", ARENSIA Exploratory Medicine Phase I Unit; 🇲🇩 Chisinau, Moldova, Republic of

Western Health; 🇦🇺 Footscray, Victoria, Australia

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong

Prince of Wales; 🇭🇰 Shatin, Hong Kong