A Clinical Study of HH-006 in Untreated Chronic Hepatitis B Virus Infected Patients (NCT07515209) | Clinical Trial Compass
CompletedPhase 1
A Clinical Study of HH-006 in Untreated Chronic Hepatitis B Virus Infected Patients
China36 participantsStarted 2024-12-20
Plain-language summary
This is a randomized, double-blind, placebo-controlled Phase I dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of multiple ascending doses (120 mg, 240 mg, 480 mg SC, QW×5) of HH-006 in untreated chronic HBV patients. Each cohort includes 12 participants (9 active, 3 placebo), with dose progression approved by a Safety Review Committee. Participants are monitored through 24 weeks post-dose. The study design allows for adjustments based on emerging data.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion Criteria:
* Male or female aged 18 to 60 years (inclusive);
* Male weight ≥ 45 kg, female weight ≥ 40 kg, and body mass index (BMI, BMI = weight/height²): 18 kg/m² ≤ BMI ≤ 32 kg/m²;
* HBsAg positive for more than 6 months (including 6 months), and with 100 IU/mL \< HBsAg \< 5000 IU/mL prior to randomization;
* HBV DNA ≥ 100 IU/mL prior to randomization;
* ALT ≤ 5 × ULN prior to randomization;
* No prior interferon antiviral therapy within 1 year before the screening period, and no prior treatment with nucleos(t)ide analogues within 6 months before the screening period;
* Males not having undergone sterilization surgery and females not postmenopausal for less than two years must agree to use adequate and effective contraceptive measures from screening until the last follow-up visit of the study (including hormonal contraceptives, intrauterine devices, cervical caps, or condoms);
* Subjects must understand and comply with the study procedures, participate voluntarily, and sign the informed consent form.
Exclusion Criteria:
* Females who are pregnant, breastfeeding, or have a positive pregnancy test at baseline with childbearing potential.
* Co-infection with hepatitis C, syphilis, or HIV.
* History of alcoholic liver disease, non-alcoholic steatohepatitis, autoimmune liver disease or other hereditary liver diseases, drug-induced liver disease, or other clinically significant chronic liver diseases not caused by HBV.
* History of or concurrent progressive liver fibr…
What they're measuring
1
Incidence of adverse events (AEs) and serious adverse events (SAEs)