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
A Phase 1, Double-Blind, Randomized, Placebo-Controlled, First-in-Human Study of Subcutaneously Administered ALG-020572 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single Ascending Doses in Healthy Volunteers (Part 1) and Multiple Doses in Subjects With Chronic Hepatitis B (Part 2)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Auckland, New Zealand
- Auckland Clinical Studies
-
-
-
-
-
London, United Kingdom
- King's College Hospital
-
London, United Kingdom
- St George's University of London
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria for Healthy Subjects:
- Male and Female between 18 and 55 years old
- Female subjects must have a negative serum pregnancy test at screening
- BMI 18.0 to 32.0 kg/m^2
- Subjects must have a 12-lead ECG that meets protocol criteria
Inclusion Criteria for CHB Subjects:
- Male and Female between 18 and 75 years old
- Female subjects must have a negative serum pregnancy test at screening
- BMI 18.0 to 35.0 kg/m^2
- For virally suppressed subjects, must be currently receiving HBV NA treatment for ≥6 months prior to screening. For currently not treated or treatment naïve subjects, must have never received treatment OR have not been on treatment within 6 months prior to randomization
- Subjects must have a 12-lead ECG that meets protocol criteria
Exclusion Criteria for Healthy Subjects:
- Subjects with any current or previous illness that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject or that could prevent, limit, or confound the protocol specified assessments or study results' interpretation
- Subjects with a past history of cardiac arrhythmias, risk factors for Torsade de Pointes syndrome (e.g., hypokalemia, family history of long QT Syndrome) or history or clinical evidence at screening of significant or unstable cardiac disease etc.
- Subjects with a history of clinically significant drug allergy
- Subject with current or history of clinically significant (as determined by the Investigator) skin disease requiring intermittent or chronic treatment
- Excessive use of alcohol defined as regular consumption of ≥14 units/week for women and ≥21 units/week for men
- Unwilling to abstain from alcohol use for 48 hours prior to start of dosing through end of study follow up
- Subjects with Hepatitis A, B, C, D, E or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection
- Subjects with renal dysfunction (e.g., estimated creatinine clearance <90 mL/min/1.73 m^2 at screening, calculated by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula)
Exclusion Criteria for CHB Subjects:
- Subjects with any current or previous illness that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject or that could prevent, limit, or confound the protocol specified assessments or study results' interpretation
- Subjects with a past history of cardiac arrhythmias, risk factors for Torsade de Pointes syndrome (e.g., hypokalemia, family history of long QT Syndrome) or history or clinical evidence at screening of significant or unstable cardiac disease etc.
- Subjects with a history of clinically significant drug allergy
- Subject with current or history of clinically significant (as determined by the Investigator) skin disease requiring intermittent or chronic treatment
- Excessive use of alcohol defined as regular consumption of ≥14 units/week for women and ≥21 units/week for men
- Subjects with Hepatitis A, C, D, E or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection
- Subjects with renal dysfunction (e.g., estimated creatinine clearance <90 mL/min/1.73 m^2 at screening, calculated by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula)
- Subject with any history or current evidence of hepatic decompensation such as: variceal bleeding, spontaneous bacterial peritonitis, ascites, hepatic encephalopathy, or active jaundice (within the last year)
- Subjects must have absence of signs of hepatocellular carcinoma
- Subjects with history or current liver cirrhosis
- Subjects positive for anti-HBs antibodies
- Subjects with liver fibrosis that is classified as Metavir Score ≥F3
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: ALG-020572
Subcutaneous injections of ALG-020572 in HV or CHB subjects, up to 7 injections over the course of up to 29 days
|
Single or multiple doses of ALG-020572
|
|
Placebo Comparator: Placebo
Subcutaneous injections of placebo in HV or CHB subjects, up to 7 injections over the course of up to 29 days
|
Single or multiple doses of Placebo
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: up to 60 days for Part 1
|
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
|
up to 60 days for Part 1
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: up to 120 days for Part 2
|
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
|
up to 120 days for Part 2
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximum Plasma Concentration [Cmax]
Time Frame: Predose (0 hours) up to 45 Days (1080 hours)
|
Pharmacokinetic parameters of ALG-020572 in plasma
|
Predose (0 hours) up to 45 Days (1080 hours)
|
|
Area under the concentration time curve [AUC]
Time Frame: Predose (0 hours) up to 45 Days (1080 hours)
|
Pharmacokinetic parameters of ALG-020572 in plasma
|
Predose (0 hours) up to 45 Days (1080 hours)
|
|
Time to maximum plasma concentration [Tmax]
Time Frame: Predose (0 hours) up to 45 Days (1080 hours)
|
Pharmacokinetic parameters of ALG-020572 in plasma
|
Predose (0 hours) up to 45 Days (1080 hours)
|
|
Half-time [t1/2]
Time Frame: Predose (0 hours) up to 45 Days (1080 hours)
|
Pharmacokinetic parameters of ALG-020572 in plasma
|
Predose (0 hours) up to 45 Days (1080 hours)
|
|
Minimum Plasma Concentration [Cmin]
Time Frame: Predose (0 hours) up to 45 Days (1080 hours)
|
Pharmacokinetic parameters of ALG-020572 in plasma
|
Predose (0 hours) up to 45 Days (1080 hours)
|
|
Change in HBsAg (reduction) from baseline through Day 120 in Multiple Dose HBV Infected Patients
Time Frame: Screening, Day 1, 2, 4, 8, 11, 15, 22, 29, 36, 45, 60, 90, 120
|
Screening, Day 1, 2, 4, 8, 11, 15, 22, 29, 36, 45, 60, 90, 120
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- ALG-020572-401
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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