A Phase 1 interventional study of HH-1270 and placebo in Chronic HDV Infection, sponsored by Huahui Health. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Huahui Health · Phase 1, Interventional, and Treatment
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.
SAD consists of 6 prespecified dose levels. Participants are enrolled in cohorts according to the dose-escalation principle and randomized to receive HH-1270 tablets (A) or placebo (P). Higher dose cohorts may begin only after confirmation by the SRC for the lower dose cohort. This part aims to evaluate the safety, tolerability, PK, and PD characteristics of single-dose HH-1270. One dose cohort in the SAD phase will be selected for a food-effect exploration.
MAD consists of 4 prespecified dose levels. Each participant receives once-daily dosing under fasting conditions for 7 consecutive days and is randomized to receive HH-1270 tablets (A) or placebo (P). Higher dose cohorts may begin only after confirmation by the SRC for the lower dose cohort. This part aims to evaluate the safety, tolerability, PK, and PD characteristics of multiple-dose HH-1270.
Huahui Health is the lead sponsor of 18 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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: HH-1270
SAD groups will be received HH-1270 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
Drug: placebo
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
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
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Number of subjects with adverse events (AEs) and serious adverse events (SAEs) assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v6.0.
Time frame: up to 15/21 days in SAD/MAD
Clinically significant abnormalities
Number of subjects with clinically significant abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters graded by CTCAE v6.0.
Time frame: up to 14/21 days in SAD/MAD
Area Under the Plasma Concentration Versus Time Curve (AUC)
AUC of HH-1270 in plasma
Time frame: up to 8/14 days in SAD/MAD
Maximum Plasma Concentration (Cmax)
Cmax of HH-1270 in plasma
Time frame: up to 8/14 days in SAD/MAD
Time to Reach Maximum Plasma Concentration (Tmax)
Tmax of HH-1270 in plasma
Time frame: up to 8/14 days in SAD/MAD
Apparent Terminal Elimination Half-life (T1/2)
T1/2 of HH-1270 in plasma
Time frame: up to 8/14 days in SAD/MAD
Apparent Plasma Clearance (CL/F)
CL/F of HH-1270 in plasma
Time frame: up to 8/14 days in SAD/MAD
Apparent volume of distribution（Vd/F）
Vd/F of HH-1270 in plasma
Time frame: up to 8/14 days in SAD/MAD
To evaluate the TBA level
TBA level for each collection point
Time frame: up to 15/21 days in SAD/MAD
To evaluate the CP-1 level
CP-1 level for each collection point
Time frame: up to 15/21 days in SAD/MAD
To evaluate QTc change
QTc values in each collection point
Time frame: up to 8 days in SAD
Start is estimated for Oct 2026; primary completion for Feb 2027, 3 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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