A Study of ALG-125755 to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After Single Doses in Healthy Volunteers, and Single and Multiple Doses in CHB Subjects

Phase 1

Terminated

• Conditions: Chronic Hepatitis B
• Interventions: Drug: Placebo; Drug: ALG-125755

• Registration Number: NCT05561530
• Lead Sponsor: Aligos Therapeutics

Brief Summary

A randomized study of ALG-125755 to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics after single doses in healthy volunteers, and single and multiple doses in CHB subjects

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-26
• Study First Submitted QC: 2022-09-28
• Study First Posted: 2022-09-30
• Study Start: 2022-10-07
• Primary Completion: 2023-06-15
• Study Completion: 2023-06-15
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 57

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 6 injections over the course of up to 72 weeks
ALG-125755	ALG-125755	Subcutaneous injections of ALG-125755 in HV or CHB subjects, up to 6 injections over the course of up to 72 weeks

Primary Outcome Measures

Name	Time	Method
Incidence and severity of treatment emergent adverse events as assessed by DAIDS v2.1	Up to 616 days for Part 3
Incidence and severity of treatment emergent adverse events as assessed by DAIDS v2.1 of various doses of ALG-125755 in HV subjects and CHB subjects	Up to 32 days for Part 1

Secondary Outcome Measures

Name	Time	Method
Minimum plasma concentration (Cmin)	Predose (0 hours) up to 616 days	Pharmacokinetic parameters of ALG-125755 in plasma
Change in HBsAg from baseline through up to 112 days from last dose in multiple dose HBV infected subjects	screening to up to 112 days
Area under the concentration time curve [AUC]	Predose (0 hours) up to 616 days	Pharmacokinetic parameters of ALG-125755 in plasma
Maximum plasma concentration (Cmax)	Predose (0 hours) up to 616 days	Pharmacokinetic parameters of ALG-125755 in plasma
Time to maximum plasma concentration [Tmax]	Predose (0 hours) up to 616 days	Pharmacokinetic parameters of ALG-125755 in plasma
Antiviral activity of ALG-125755 as measured by quantitative changes in serum	Predose (0 hours) up to 616 days	Pharmacokinetic parameters of ALG-125755 in plasma

Trial Locations

Locations (4)

MBAL Sveta Sofia EOOD, Dept of Internal Medicine with Gastroenterology Section; 🇧🇬 Sofia, Bulgaria

PMSI Republican Clinical Hospital "t. Mosneaga", ARENSIA Exploratory Medicine Phase 1 Unit; 🇲🇩 Chisinau, Moldova, Republic of

New Zealand Clinical Research; 🇳🇿 Auckland, New Zealand

National Institute for Infection Diseases, ARENSIA Exploratory Medicine S.R.L.; 🇷🇴 Bucharest, Romania