- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04536337
A Study of ALG-000184 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single and Multiple Doses in Healthy Volunteers and CHB Subjects
A Phase 1, Double-Blind, Randomized, Placebo-Controlled, First-in-Human Study of Orally Administered ALG-000184 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single-Ascending Doses (Part 1) and Multiple-Ascending Doses in Healthy Volunteers (Part 2), and Multiple Doses in Subjects With Chronic Hepatitis B (Part 3)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Victoria
-
Fitzroy, Victoria, Australia, 3065
- Recruiting
- Saint Vincent's Hospital Melbourne
-
Contact:
- Jacinta McMahon
- Phone Number: 6192313518
- Email: jacinta.mcmahon@svha.org.au
-
Footscray, Victoria, Australia, 3011
- Not yet recruiting
- Western Health
-
Contact:
- Kerrie Curin
- Phone Number: (03) 8345 6291
- Email: WHS-GastroResearch@wh.org.au
-
-
-
-
Chongqing
-
Chongqing, Chongqing, China, 400016
- Recruiting
- The Second Affiliated Hospital of Chongqing Medical University
-
Contact:
- Yi Yang
- Phone Number: 13983888786
- Email: 316878404@qq.com
-
-
Guangdong
-
Guangzhou, Guangdong, China
- Recruiting
- NanFang Hospital of Southern Medical University
-
-
Jilin
-
Changchun, Jilin, China, 130021
- Recruiting
- The first hospital of Jilin University
-
-
-
-
-
Hong Kong, Hong Kong
- Recruiting
- Queen Mary Hospital
-
Shatin, Hong Kong
- Not yet recruiting
- Prince of Wales
-
Contact:
- Angel Chim
- Email: angelchim@cuhk.edu.hk
-
-
-
-
-
Quatre Bornes, Mauritius, 72218
- Not yet recruiting
- CAP Research
-
Contact:
- Rina Dookaya
- Phone Number: 2304602144
- Email: rina.dookaya@cap-research.com
-
-
-
-
-
Chisinau, Moldova, Republic of
- Recruiting
- PMSI Republican Clinical Hospital "T. Mosneaga", ARENSIA Exploratory Medicine Phase I Unit
-
-
-
-
-
Auckland, New Zealand
- Recruiting
- ACS
-
-
-
-
-
London, United Kingdom
- Recruiting
- King's College Hospital
-
London, United Kingdom, SW170RE
- Not yet recruiting
- St George's University of London
-
Contact:
- Hananh Rine
- Phone Number: 02087255375
- Email: hannah.rine@st.georges.nhs.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria for All Subjects:
- Female subjects must have a negative serum pregnancy test at screening
Subjects must have a 12-lead electrocardiogram (ECG) that meets the protocol criteria
Inclusion Criteria for Healthy Volunteers:
In addition to inclusion criteria 1-2, the following inclusion criteria also apply to HV's (Parts 1 and 2)
- Male or female between 18 and 55 years of age, extremes included.
- Subjects must have a body mass index (BMI; weight in kg divided by the square of height in meters) of 18.0 to 32.0 kg/m2, extremes included.
CHB Subjects:
In addition to inclusion criteria 1-4, the following inclusion criteria also apply to CHB subjects:
All of the Following criteria apply to Part 3 at screening:
5 .Subjects must be 18 to 65 years of age, extremes included.
6.CHB subjects must have a BMI of 18.0 to 35.0 kg/m2, extremes included.
7.CHB subjects who at screening, have not received treatment with an approved or investigational medicine, or have never received treatment with HBV antiviral medicines
All of the following criteria apply to Part 4 Cohorts A & B, unless otherwise specified, at Screening:
8.Subjects must be 18 to 65 years of age, extremes included.
9.Subjects must have a BMI of 18.0 to 35.0 kg/m2, extremes included
10.Subjects must be HBeAg positive (HBeAg ≥LLOQ and HBeAb negative)
11.Subjects enrolled in Part 4 Cohort A and B must have a history of Chronic Hepatitis B
12. Subjects must have ALT and AST must have ≤1.2×ULN or ≤5×ULN
All of the following criteria apply to Part 5 at Screening
13.Subjects must be 18 to 65 years of age, extremes included.
14. Subjects have a BMI of 17.0 to 35.0 kg/m2, extremes included
15.Subjects could belong to any of the following treatment categories: treatment naïve (TN), currently not treated (CNT) , virologically suppressed.
Exclusion Criteria
Exclusion Criteria for All Subjects:
- Subjects with any previous or current 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 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 of clinical evidence at screening of significant or unstable cardiac disease etc.
- Subjects with a history of clinically significant drug allergy
- Subject with a current history of clinically significant (as determined by investigator) skin disease requiring intermittent or chronic treatment
- Excessive use of alcohol, defined as regular consumption of ≥14 standard drinks/week for women and ≥21 standard drinks/week for men
Subjects with Hepatitis A, B, C, D, E or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection
Exclusion Criteria for Healthy Volunteers (Parts 1 and 2):
In addition to exclusion criteria 1-6, the following exclusion criteria also apply to HV's (Parts 1 and 2)
- Unwilling to abstain from alcohol use for 48 hours prior to start of dosing through end of study follow up.
- Positive alcohol or cotinine test at screening and Day -1.
Subjects with renal dysfunction (e.g., estimated creatinine clearance <90 mL/min/1.73 m2at screening, calculated by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula).
Exclusion Criteria for CHB Subjects (Parts 3, 4, and 5):
All exclusion criteria listed above for healthy volunteers apply also to CHB subjects, except for exclusion Criteria 9 (requirement relative to cotinine).All the following exclusion criteria apply to Parts 3, 4, and 5, unless otherwise specified.
- Subjects who are positive for anti-HBs antibodies.
- For HBeAg-positive subjects, they should be negative for anti-HBe antibodies (Parts 4 and 5)
- 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).
- History or current evidence of cirrhosis.
- Subjects with liver fibrosis that is classified as Metavir Score ≥F3 liver disease
- Subjects with signs of hepatocellular carcinoma
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ALG-000184
Oral tablet(s) of ALG-000184 in HV or CHB subjects once daily for up to 4 weeks
|
Single or multiple doses of ALG-000184
|
Placebo Comparator: Placebo
Oral tablet(s) of placebo in HV or CHB subjects once daily for up to 4 weeks
|
Single or multiple doses of Placebo
|
Active Comparator: Entecavir in combination with ALG-000184
|
Single or multiple doses of ALG-000184
multiple doses of Entecavir
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: up to 8 days for Part 1
|
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
|
up to 8 days for Part 1
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: up to 21 days for Part 2
|
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
|
up to 21 days for Part 2
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: up to 112 days for Part 3
|
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
|
up to 112 days for Part 3
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: 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)
|
Up to 336 days for parts 4 & 5
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Plasma Concentration [Cmax]
Time Frame: Predose up to 343 Days
|
Pharmacokinetic parameters of ALG-000184 in plasma
|
Predose up to 343 Days
|
Area under the concentration time curve [AUC]
Time Frame: Predose up to 343 Days
|
Pharmacokinetic parameters of ALG-000184 in plasma
|
Predose up to 343 Days
|
Time to maximum plasma concentration [Tmax]
Time Frame: Predose up to 343 Days
|
pharmacokinetic parameters of ALG-000184 in plasma
|
Predose up to 343 Days
|
Half-time [t1/2]
Time Frame: Predose up to 343 Days
|
Pharmacokinetic parameters of ALG-000184 in plasma
|
Predose up to 343 Days
|
Minimum Plasma Concentration [Cmin]
Time Frame: Predose up to 343 Days
|
Pharmacokinetic parameters of ALG-000184 in plasma
|
Predose up to 343 Days
|
Change in HBV DNA from baseline through Day 392 in Multiple Dose HBV Infected Patients
Time Frame: Screening up to Day 392
|
Screening up to Day 392
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALG-000184-201
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Hepatitis B
-
The Affiliated Nanjing Drum Tower Hospital of Nanjing...Gilead SciencesNot yet recruiting
-
Tongji HospitalGilead SciencesRecruiting
-
Jiangsu HengRui Medicine Co., Ltd.Unknown
-
Changhai HospitalCompleted
-
Tongji HospitalChia Tai Tianqing Pharmaceutical Group Co., Ltd.UnknownChronic Hepatitis b
-
Zhongshan Hospital Xiamen UniversityUnknownHealthy | Chronic Hepatitis B InfectionChina
-
Brii Biosciences LimitedVir Biotechnology, Inc.Active, not recruitingChronic Hepatitis B Virus InfectionSingapore, Thailand, Australia, China, Korea, Republic of
-
Nanfang Hospital of Southern Medical UniversityRecruiting
-
IlDong Pharmaceutical Co LtdRecruitingChronic Hepatitis bKorea, Republic of
-
Antios Therapeutics, IncTerminatedChronic Hepatitis bUnited States
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States