This is a Phase 1 Study in Which Healthy Volunteers and Participants with Chronic HBV Infection W… (NCT06746311) | Clinical Trial Compass
CompletedPhase 1
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
China82 participantsStarted 2022-11-22
Plain-language 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).
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, nerv…
What they're measuring
1
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Timeframe: From enrollment to the end of treatment at 24 weeks
2
Clinically significant abnormalities
Timeframe: From enrollment to the end of treatment at 24 weeks