First-in-Human study of a medication called ALG-020572 to determine how it works in people with Chronic Hepatitis B
- Conditions
- Chronic viral hepatitis BInfections and InfestationsHep B, HBV
- Registration Number
- ISRCTN13113768
- Lead Sponsor
- Aligos Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 112
Parts 1 and 2:
1. Signed informed consent form (ICF) indicating that the participants understand the purpose of, and procedures required for, the study, and are willing to participate in the study
2. In the Investigator’s opinion, the participant is able to understand and comply with protocol requirements, instructions, and protocol stated restrictions and is likely to complete the study as planned
3. Female participants must have a negative serum (ß human chorionic gonadotropin) pregnancy test at screening and a negative urine pregnancy test at Day -1 (Part 1) or Week -1 Screening (Part 2)
4. Female participants must not be a woman of childbearing potential (WOCBP) defined as either:
4.1. Postmenopausal. A postmenopausal state is defined as no menses for 12 months without an alternative medical explanation. A high follicle-stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy (HRT). In the absence of 12 months of amenorrhea, 2 FSH measurements at least 3 months apart and in the postmenopausal range must be documented. If there is a question about menopausal status in women on HRT, the woman will be required to use one of the non-estrogen-containing hormonal highly effective contraceptive methods if she wishes to continue HRT during the study.
4.2. Permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy.
5. Male participants must agree to wear a condom during sexual intercourse and their female sexual partners must agree to use highly effective means of contraception. These contraceptive measures must be implemented, at a minimum, from the start of dosing until at least 120 days after the last dose. Contraceptive use should be consistent with local regulations regarding the use of contraceptive methods for subjects participating in clinical studies.
6. Participants must have a 12-lead electrocardiogram (ECG) that meets the following criteria (ECG intervals will be based on the mean value of triplicate ECGs collected at screening):
6.1. Heart rate =40 bpm and =100 bpm
6.2. QT interval corrected for heart rate (QTc) according to Fridericia’s formula (QTcF) =450 ms (males) or =470 ms (females)
6.3. QRS interval <120 ms
6.4. PR interval =200 ms (Part 1) or =220 ms (Part 2)
6.5. In addition to fulfilling the above ECG criteria, ECG morphology must have no clinically significant abnormalities observed.
Retesting of an apparently exclusionary ECG will be allowed once without prior approval from the Sponsor. Participants with a retest (triplicate) ECG without clinically significant abnormalities as per this inclusion criterion may be included.
7. Participants must be deemed to be in good overall health by the Investigator on the basis of a medical evaluation that reveals the absence of any clinically significant abnormality and includes a physical examination, medical history, vital signs, and the results of blood chemistry, blood coagulation and hematology tests, and a urinalysis performed at screening
8. Participants must be willing an
Parts 1 and 2:
1. 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 participant, or that could prevent, limit, or confound the protocol-specified assessments or study results' interpretation. This may include, but is not limited to, renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, dermatologic, hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances.
2. 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 of significant or unstable cardiac disease at screening (such as angina, congestive heart failure, myocardial infarction, diastolic dysfunction, significant arrhythmia, coronary heart disease, clinically significant ECG abnormalities, moderate to severe valvular disease or uncontrolled hypertension)
3. History of clinically significant drug allergy such as, but not limited to, sulfonamides or drug allergy witnessed in previous studies with experimental drugs
4. Personal or family history of chronic inflammatory skin disease (e.g. psoriasis, atopic dermatitis, drug-related rash, chronic urticaria)
5. Recent (within 1 year of randomization) history or current evidence of use of amphetamines, barbiturates, narcotics or other drugs of abuse/recreational drug use. Use of these drugs under physician supervision (e.g. prescription narcotics for known pain disorder) and cannabis use is not exclusionary.
6. Excessive use of alcohol. Defined as regular consumption of =14 standard drinks/week for women and =21 standard drinks/week for men. For a current definition of a standard drink, please refer to the National Institute on Alcohol Abuse and Alcoholism website (https://www.niaaa.nih.gov/what-standard-drink).
7. Positive alcohol test at screening and Day -1 (Part 1) and Week -1 Screening (Part 2)
8. Current Hepatitis A (HAV) infection, confirmed by hepatitis A antibody immunoglobulin M (IgM) at screening
9. Current Hepatitis C virus (HCV) infection (confirmed by HCV antibody and/or HCV RNA). Participants who have been treated and achieved sustained virologic response >1 year prior to screening with HCV RNA LLOQ, target not detected, remain eligible.
10. Current Anti-HEV IgM positive and/or detectable HEV RNA level (only applies to participants with a history of living or traveling to an HEV epidemic area)
11. Current Human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection, confirmed by antibodies at screening
12. Acute infection at the time of randomization. If an acute infection is considered resolved prior to randomization, the participant remains eligible.
13. Received an unapproved investigational agent or vaccine within 4 weeks (or 5 half-lives, whichever is longer) prior to randomization
14. Currently participating in another clinical or medical interventional research study
15. Any Grade >1 laboratory abnormality (as defined by the Division of AIDS Toxicity Grading Scale) that is considered clinically significant by the Investigator at screening
16. Clinically significant ab
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method