Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

NOT YET RECRUITING

NCT07876440

PHASE1

A Clinical Study of HH-1270 in Healthy Chinese Subjects

Sponsor: Huahui Health

View on ClinicalTrials.gov

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.

Official title: A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of HH-1270 Tablets in Healthy Chinese Participants

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-10-19

Completion Date

2027-07-06

Last Updated

2026-10-15

Healthy Volunteers

Yes

Conditions

Chronic HDV Infection

Interventions

DRUG

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

DRUG

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

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.

Locations (1)

Peking University Third Hospital

Beijing, Beijing Municipality, China