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

NCT06746311 | Completed Phase 1

• 1 other identifier: HT-101-101
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 7

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).

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (2)

• 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.

  From enrollment to the end of treatment at 24 weeks

• Clinically significant abnormalities

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

  From enrollment to the end of treatment at 24 weeks

Secondary Outcomes (9)

• Maximum Plasma Concentration (Cmax)

  From predose 0.5 hours to postdose 48 hours.

• Time to Reach Maximum Plasma Concentration (Tmax)

  From predose 0.5 hours to postdose 48 hours.

• Area Under the Plasma Concentration Versus Time Curve (AUC)

  From predose 0.5 hours to postdose 48 hours.

• Apparent Terminal Elimination Half-life (T1/2)

  From predose 0.5 hours to postdose 48 hours.

• Apparent Plasma Clearance (CL/F)

  From predose 0.5 hours to postdose 48 hours.

Study Arms (2)

Part A

EXPERIMENTAL

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

Drug: HT-101; Drug: Placebo

Part B

EXPERIMENTAL

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

Drug: HT-101; Drug: Placebo

Interventions

HT-101 DRUG

Single dose of HT-101 administered subcutaneously.

Part A

Placebo DRUG

Placebo, containing no active ingredient, administered subcutaneouly

Part A; Part B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Suzhou HepaThera Biotech Co., Ltd.: lead

Study Sites (7)

Beijing Ditan Hospital Capital Medical University

Beijing, Beijing Municipality, 100015, China

Location

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

Location

Nanfang Hospital

Guangzhou, Guangdong, 510515, China

Location

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221132, China

Location

The First Bethune Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Yanbian University Hospital

Yanji, Jilin, 133000, China

Location

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, 200083, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 24, 2024
• Study Start: November 22, 2022
• Primary Completion: May 13, 2024
• Study Completion: June 17, 2024
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)