Chronic HDV InfectionPhase 1NCT07876440
A Clinical Study of HH-1270 in Healthy Chinese Subjects
A Phase 1 study testing HH-1270 in people with Chronic HDV Infection, run by Huahui Health at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic HDV Infection
- What is being tested?
- HH-1270
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 19 Oct 2026to 6 Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
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
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.
Read the detailed description
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.
- Conditions
- Chronic HDV Infection
- Being tested
- HH-1270, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HH-1270Drug
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
placeboDrug
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 group | Role | What they receive |
|---|---|---|
| HH-1270 group | Experimental | 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 Receives: Drug: HH-1270 |
| Placebo group | Placebo comparator | 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 Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 14/21 days in SAD/MAD
Secondary outcomes (8)
Area Under the Plasma Concentration Versus Time Curve (AUC)
AUC of HH-1270 in plasma
Measured: up to 8/14 days in SAD/MAD
Maximum Plasma Concentration (Cmax)
Cmax of HH-1270 in plasma
Measured: up to 8/14 days in SAD/MAD
Time to Reach Maximum Plasma Concentration (Tmax)
Tmax of HH-1270 in plasma
Measured: up to 8/14 days in SAD/MAD
Apparent Terminal Elimination Half-life (T1/2)
T1/2 of HH-1270 in plasma
Measured: up to 8/14 days in SAD/MAD
Apparent Plasma Clearance (CL/F)
CL/F of HH-1270 in plasma
Measured: up to 8/14 days in SAD/MAD
Apparent volume of distribution（Vd/F）
Vd/F of HH-1270 in plasma
Measured: up to 8/14 days in SAD/MAD
To evaluate the TBA level
TBA level for each collection point
Measured: up to 15/21 days in SAD/MAD
To evaluate the CP-1 level
CP-1 level for each collection point
Measured: up to 15/21 days in SAD/MAD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start19 Oct 2026 (estimated)
- Primary completion5 Feb 2027 (estimated)
- Study completion6 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic HDV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huahui Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876440
- Sponsor's protocol ID
- HH1270-101
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07876440
- Acronym / sponsor ID
- HH1270-101
- Conditions
- Chronic HDV Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Huahui HealthIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2026 (estimated)
- Primary completion
- 5 Feb 2027 (estimated)
- Study completion
- 6 Jul 2027 (estimated)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HH-1270 group | Experimental | Drug: HH-1270SAD 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 group | Placebo comparator | Drug: placeboSAD 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HH-1270SAD 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 group |
| placeboSAD 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 | Drug | Placebo group |
Primary outcome
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: 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
Time frame: 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.
8 secondary outcomes
Area Under the Plasma Concentration Versus Time Curve (AUC)
Time frame: up to 8/14 days in SAD/MAD
Maximum Plasma Concentration (Cmax)
Time frame: up to 8/14 days in SAD/MAD
Time to Reach Maximum Plasma Concentration (Tmax)
Time frame: up to 8/14 days in SAD/MAD
Apparent Terminal Elimination Half-life (T1/2)
Time frame: up to 8/14 days in SAD/MAD
Apparent Plasma Clearance (CL/F)
Time frame: up to 8/14 days in SAD/MAD
Apparent volume of distribution（Vd/F）
Time frame: up to 8/14 days in SAD/MAD
To evaluate the TBA level
Time frame: up to 15/21 days in SAD/MAD
To evaluate the CP-1 level
Time frame: up to 15/21 days in SAD/MAD
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HH-1270 in people with Chronic HDV Infection, run by Huahui Health at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiyu Zhang (18701650516, zhangxiyu@hhhbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) and serious adverse events (SAEs) (time frame: up to 15/21 days in SAD/MAD). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.