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Completed

NCT Number: NCT06746311

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

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).

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Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing Ditan Hospital Capital Medical University, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

HT-101

Drug

Single dose of HT-101 administered subcutaneously.

Placebo

Drug

Placebo, containing no active ingredient, administered subcutaneouly

Primary outcomes

  1. Incidence of adverse events (AEs) and serious adverse events (SAEs)

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

    Number of subjects with adverse events (AEs) and serious adverse events (SAEs) assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

  2. Clinically significant abnormalities

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

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

Secondary outcomes

  1. Maximum Plasma Concentration (Cmax)

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

    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.

  2. Time to Reach Maximum Plasma Concentration (Tmax)

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

    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.

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

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

    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.

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

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

    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.

  5. Apparent Plasma Clearance (CL/F)

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

    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.

  6. apparent volume of distribution（Vd/F）

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

    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.

  7. Maximum Change of Serum HBsAg From Baseline

    Time frame: Up to 24 weeks

    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)

  8. Maximum Change of Serum HBV DNA From Baseline

    Time frame: Up to 24 weeks

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

  9. Number of participants with HBeAg Loss

    Time frame: Up to 24 weeks

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

Sponsors and collaborators

Lead sponsor

Suzhou HepaThera Biotech Co., Ltd.

Industry

Registry information

Official study title

Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of HT-101 Injection in Healthy Subjects and Patients with Chronic Hepatitis B Virus Infection: a Randomized, Double-blind, Placebo-controlled, Single and Multiple Doses, and Dose Escalation Phase 1 Clinical Study

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 24, 2024
Registry last updated
Dec 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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