Clinical trial 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
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis B
Lead sponsor: Suzhou HepaThera Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-12-24
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


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;

Primary outcomes:
measure: Incidence of adverse events (AEs) and serious adverse events (SAEs)
timeFrame: From enrollment to the end of treatment at 24 weeks
measure: Clinically significant abnormalities
timeFrame: From enrollment to the end of treatment at 24 weeks
Secondary outcomes:
measure: Maximum Plasma Concentration (Cmax)
timeFrame: From predose 0.5 hours to postdose 48 hours.
measure: Time to Reach Maximum Plasma Concentration (Tmax)
timeFrame: From predose 0.5 hours to postdose 48 hours.
measure: Area Under the Plasma Concentration Versus Time Curve (AUC)
timeFrame: From predose 0.5 hours to postdose 48 hours.
measure: Apparent Terminal Elimination Half-life (T1/2)
timeFrame: From predose 0.5 hours to postdose 48 hours.
measure: Apparent Plasma Clearance (CL/F)
timeFrame: From predose 0.5 hours to postdose 48 hours.
measure: apparent volume of distribution（Vd/F）
timeFrame: From predose 0.5 hours to postdose 48 hours.
measure: Maximum Change of Serum HBsAg From Baseline
timeFrame: Up to 24 weeks
measure: Maximum Change of Serum HBV DNA From Baseline
timeFrame: Up to 24 weeks
measure: Number of participants with HBeAg Loss
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan Hospital Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital
state: Beijing
city: Guangzhou
country: China
facility: Nanfang Hospital
state: Guangdong
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin University
state: Jilin
city: Yanji
country: China
facility: Yanbian University Hospital
state: Jilin
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
state: Shanghai
Study officials:
References: