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 range18 Years – 65 Years
SexALL
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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…
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