Clinical Trials in China / NCT07876440
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Phase 1
A Clinical Study of HH-1270 in Healthy Chinese Subjects
NCT07876440 · tracked via the Priya Life Science China tracker
Condition(s) studied
Chronic HDV Infection
Investigational drug(s) / intervention(s)
HH-1270placebo
HH-1270: SAD groups will be received HH-1270 tablets from 5mg to 200mg once and MAD groups will be received HH-1270 tablets from 5 mg to 60 mg once per day for 7 days
placebo: SAD groups will be received placebo tablets from 5mg to 200mg once and MAD groups will be received HH-1270 placebo tablets from 5 mg to 60 mg once per day for 7 days
Study summary
This study is a single-center, randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial to evaluate the safety and PK profile in healthy Chinese subjects.
Eligibility
Inclusion Criteria:
* Healthy Chinese adults aged 18 to 55 years (inclusive), both male and female.
* Weight: male ≥50.0 kg, female ≥45.0 kg, and body mass index (BMI) 18.0 to 28.0 kg/m² (inclusive; BMI = weight/height²).
* Results of vital signs, physical examination, laboratory tests, and 12-lead electrocardiogram (ECG) at screening are normal or abnormal without clinical significance.
* Participants must agree to take adequate and effective contraceptive measures.
* Participants understand and comply with the study procedures, voluntarily participate, and sign the informed consent form (ICF).
Exclusion Criteria:
* Individuals with severe systemic diseases, infectious diseases, or mental disorders.
* Clinically significant electrocardiogram (ECG) abnormalities.
* History of clinically significant drug allergy or atopic allergic diseases.
* Comorbid conditions that may affect drug absorption, distribution, metabolism, excretion, and interpretation of safety data, or that may reduce compliance, including but not limited to any of the following.
* Positive results for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or Treponema pallidum antibody (TPAb).
* History of drug abuse or alcoholism within 12 months before screening, or evidence of alcohol abuse or excessive drinking confirmed by an alcohol breath test at screening.
* Frequent use of tobacco or nicotine products (e.g., patches, gum, etc.) or any other smoking products within 30 days before screening.
* Blood donation ≥400 mL within 3 months before screening.
* Participation in another interventional clinical trial within 3 months before screening.
* Use of any prescription medication within 4 weeks or 5 half-lives (whichever is longer) before screening.
* Use of over-the-counter drugs, health supplements, herbal medicines, or traditional Chinese medicines, or use of medications that affect drug metabolism, within 2 weeks before screening.
* Known or suspected history of allergy to any component of HH-1270 tablets or their excipients.
* Inability to accept standardized diet management at the study center.
* Participants who are breastfeeding or have a positive pregnancy test before the first dose.
* Participants deemed unsuitable for participation in the study by the investigator.
Primary outcome measure(s)
- Incidence of adverse events (AEs) and serious adverse events (SAEs) — up to 15/21 days in SAD/MAD
Number of subjects with adverse events (AEs) and serious adverse events (SAEs) assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v6.0. - Clinically significant abnormalities — up to 14/21 days in SAD/MAD
Number of subjects with clinically significant abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters graded by CTCAE v6.0.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Peking University Third Hospital | Beijing | Beijing Municipality |
More Huahui Health trials in China
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07876440 on ClinicalTrials.gov ↗ ← All trials in China