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CompletedNCT06746311Updated Dec 24, 2024

This is a Phase 1 Study in Which Healthy Volunteers and Participants with Chronic HBV Infection Will Receive HT-101 or Placebo and Will Be Assessed for Safety, Tolerability, Pharmacokinetics (PK), and Antiviral Activity

A Phase 1 interventional study of HT-101 and HT-101 in Chronic Hepatitis B, sponsored by Suzhou HepaThera Biotech Co., Ltd.. Completed at 7 sites in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-24.

Sponsored by Suzhou HepaThera Biotech Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years after the study started (first participant enrolled Nov 2022, registered Dec 2024).
Phase
Phase 1
Study type
Interventional
Enrollment
82
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Phase 1 Study of HT-101 in Healthy Subjects and Patients With Chronic Hepatitis B The trial consisted of two components. Part A involved a single ascending dose study where healthy participants were administered one dose of HT-101 or placebo subcutaneously (SC). Part B involved a multiple ascending dose study where participants with chronic hepatitis B virus infection were administered two dose of HT-101 or placebo every 4 weeks subcutaneously (SC).

02

Conditions studied

  • Chronic Hepatitis B
03

In context

Hepatitis B

1,656 studies on the registry are indexed under Hepatitis B; 196 are open to participants now.

This study's enrollment of 82 is below the median of 120 across 1,187 interventional studies indexed under Hepatitis B.

Browse Hepatitis B studies →

Lead sponsor

Suzhou HepaThera Biotech Co., Ltd. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria: Subjects were eligible for inclusion into the study if they met each of the following criteria:

Part A SAD: Healthy Participant

  • Male participants weighed ≥ 50.0 kg, female participants weighed ≥ 45.0 kg;
  • Participants who promise having used effective contraception for at least 1 month before screening, and have no plans for pregnancy or donating sperm or eggs, and will voluntarily use effective physical means of contraception (including the partner) during the study and for 3 months after the end of the study;

Part B MAD: Patient with CHB

  • Male subjects weighed ≥ 50.0 kg, female subjects weighed ≥ 45.0 kg, with a body mass index (BMI) between 19.0 and 28.0 kg/m\^2 (inclusive);
  • Chronic HBV infection for >/= 6 months;
  • The quantitation level of HBsAg was > 200 IU/mL and \< 5000 IU/mL; The quantitation level of HBV DNA \< 2×10\^4 IU/mL;
  • Subjects promised to use effective contraception for at least 1 month before screening, and have no fertility, donate sperm or eggs and voluntarily take highly effective physical contraception (including partners) during the trial and within 3 months after the end of the trial;

Exclusion Criteria:Subjects were excluded from the study if one or more of the following criteria were applicable

  • Participants with history of drug allergy or specific allergy;
  • Participants who had psychiatric conditions or diseases in cardiovascular, respiratory, endocrine, kidney, liver, digestive tract, skin, immune, blood, nerve and other systems;
  • Participants with history of active pathological bleeding, or bleeding tendency;
  • Participants with abnormal results of physical examination, vital sign examination, ECG examination, laboratory test in the screening period which were judged as clinically significant by clinicians;
  • Participants with significant liver fibrosis or cirrhosis;
  • Participants with symptoms or a history of hepatic decompensation;
  • Participants with a history or suspected risk of liver cancerr;
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
82 participants (actual)

Study arms

  • Experimental
    Part A

    Single ascending Dose of HT-101 or placebo in Healthy participants subcustaneously.

    Drug: HT-101 · Drug: Placebo

  • Experimental
    Part B

    Multiple Ascending Dose of HT-101 or placebo in patients with Chronic hepatitis B virus subcustaneously.

    Drug: HT-101 · Drug: Placebo

Interventions

  • DrugHT-101

    Single dose of HT-101 administered subcutaneously.

  • DrugHT-101

    Multiple dose of HT-101 administered subcutaneously.

  • DrugPlacebo

    Placebo, containing no active ingredient, administered subcutaneouly

06

What researchers measure

Primary outcomes

  1. 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) v5.0.

    Time frame: From enrollment to the end of treatment at 24 weeks

  2. Clinically significant abnormalities

    Number of subjects with clinically significant abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters graded by CTCAE v5.0.

    Time frame: From enrollment to the end of treatment at 24 weeks

Secondary outcomes

  1. Maximum Plasma Concentration (Cmax)

    Cmax of HT-101 and its metabolite in plasma. First administration (Healty participants and Patients with CHB): Predose 0.5 hours; Postdose 0.5 hours, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours and 48 hours. Second administration (Patients with CHB): Predose 0.5 hours; postdose 0.5 hours, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours and 48 hours.

    Time frame: From predose 0.5 hours to postdose 48 hours.

  2. Time to Reach Maximum Plasma Concentration (Tmax)

    Tmax of HT-101 and its metabolite in plasma. First administration (Healty participants and Patients with CHB): Predose 0.5 hours; Postdose 0.5 hours, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours and 48 hours. Second administration (Patients with CHB): Predose 0.5 hours; postdose 0.5 hours, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours and 48 hours.

    Time frame: From predose 0.5 hours to postdose 48 hours.

  3. Area Under the Plasma Concentration Versus Time Curve (AUC)

    AUC of HT-101 and its metabolite from time 0 to last measurable time. First administration (Healty participants and Patients with CHB): Predose 0.5 hours; Postdose 0.5 hours,1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours and 48 hours. Second administration (Patients with CHB): Predose 0.5 hours; postdose 0.5 hours,1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours and 48 hours.

    Time frame: From predose 0.5 hours to postdose 48 hours.

  4. Apparent Terminal Elimination Half-life (T1/2)

    T1/2 of HT-101 in plasma. First administration (Healty participants and Patients with CHB): Predose 0.5 hours; Postdose 0.5 hours, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours and 48 hours. Second administration (Patients with CHB): Predose 0.5 hours; postdose 0.5 hours, 1hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours and 48 hours.

    Time frame: From predose 0.5 hours to postdose 48 hours.

  5. Apparent Plasma Clearance (CL/F)

    CL/F of HT-101 in plasma. First administration (Healty participants and Patients with CHB): Predose 0.5 hours; Postdose 0.5 hours, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours and 48 hours. Second administration (Patients with CHB): Predose 0.5 hours; postdose 0.5 hours, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours and 48 hours.

    Time frame: From predose 0.5 hours to postdose 48 hours.

  6. apparent volume of distribution（Vd/F）

    Vd/F of HT-101. First administration (Healty participants and Patients with CHB): Predose 0.5 hours; Postdose 0.5 hours, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours and 48 hours. Second administration (Patients with CHB): Predose 0.5 hours; postdose 0.5 hours, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours and 48 hours.

    Time frame: From predose 0.5 hours to postdose 48 hours.

  7. Maximum Change of Serum HBsAg From Baseline

    Maximum change of serum HBsAg from Day 1 until 24 weeks post last dose (negative values mean reductions from baseline, positive values mean increased from baseline)

    Time frame: Up to 24 weeks

  8. Maximum Change of Serum HBV DNA From Baseline

    Maximum change of serum HBV DNA from Day 1 until 24 weeks (negative values mean reductions from baseline, positive values mean increased from baseline).

    Time frame: Up to 24 weeks

  9. Number of participants with HBeAg Loss

    For HBeAg-positive Participants: Number of Subjects With HBeAg Loss

    Time frame: Up to 24 weeks

07

Study locations

7 sites
  • Beijing Ditan Hospital Capital Medical University
    Beijing, Beijing 100015, China
  • Beijing Friendship Hospital
    Beijing, Beijing 100050, China
  • Nanfang Hospital
    Guangzhou, Guangdong 510515, China
  • The Affiliated Hospital of Xuzhou Medical University
    Xuzhou, Jiangsu 221132, China
  • The First Bethune Hospital of Jilin University
    Changchun, Jilin 130021, China
  • Yanbian University Hospital
    Yanji, Jilin 133000, China
  • Shanghai Public Health Clinical Center
    Shanghai, Shanghai 200083, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06746311
Lead sponsor
Suzhou HepaThera Biotech Co., Ltd.
Responsible party
Sponsor
First posted
Dec 24, 2024
Start date
Nov 22, 2022
Primary completion
May 13, 2024
Completion
Jun 17, 2024
Last update
Dec 24, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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