Phase 1 Study of HT-102 Administered Subcustaneously in Healthy Participants and Patients with Ch… (NCT06744686) | Clinical Trial Compass
CompletedPhase 1
Phase 1 Study of HT-102 Administered Subcustaneously in Healthy Participants and Patients with Chronic Hepatitis B for Safety, Tolerability, Pharmacokinetics (PK), and Antiviral Activity (only in Participants with Chronic HBV Infection)
China56 participantsStarted 2023-06-12
Plain-language summary
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of HT-102 (BM012) Injection in Healthy Subjects and Hepatitis B e Antigen-Negative Patients with Chronic Hepatitis B Virus Infection: A Randomized, Double-blind, Placebo-controlled, Single and Multiple Subcutaneous Injections, and Dose Escalation Phase 1 Clinical Study
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
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:
Healthy Participants SAD:
* Male participants weighed ≥ 50.0 kg, female participants weighed ≥ 45.0 kg;
* Participants were healthy individuals;
* Participants promise to have no plans to have a child, donate sperm or eggs and voluntarily take effective non-drug contraception measures during the trial and within 3 months after the end of the trial;
Participants with Chronic HBV infection, MAD:
* Chronic HBV infection, and HBeAg negative;
* Patients who had received antiviral therapy for at least one year before screening and stabilization therapy with nucleoside (nucleotide) reverse transcriptase inhibitors for ≥ 3 months before screening (nucleoside (nucleotide) reverse transcriptase inhibitors;
Exclusion Criteria:
* Participants with a history of active pathological hemorrhage or those with bleeding tendency, or those with a history of neurological disease;
* Participants with major trauma or major surgery within 3 months before trial screening;
* Participants with a history of drug allergy;
* Participants who used any drugs before trial screening or are using any drugs, including vitamins and Chinese herbal medicines;
* Participants with abnormal results of ECG examination, laboratory test in the screening period which were judged as clinically significant;
* Participants who cannot tolerate subcutaneous injection;
* Patients with a previous clinical diagnosis of liver cirrhosis, or a history of alcoholic liver disease, autoimmune liver disease, i…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Timeframe: From administration to the end of treatment at 8 weeks
2
Time to Reach Maximum Plasma Concentration (Tmax)
Timeframe: From administration to the end of treatment at 8 weeks