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

Korábbi kezelés

• Participants with major trauma or major surgery within 3 months before trial screening;
• Participants who used any drugs before trial screening or are using any drugs, including vitamins and Chinese herbal medicines;
• Patients with a previous clinical diagnosis of liver cirrhosis, or a history of alcoholic liver disease, autoimmune liver disease, inherited metabolic liver disease, and other liver diseases;

Más betegség

• Participants with a history of active pathological hemorrhage or those with bleeding tendency, or those with a history of neurological disease;
• Participants with a history of drug allergy;
• Participants with a clinically significant acute infection;

Laborértékek

• Participants with abnormal results of ECG examination, laboratory test in the screening period which were judged as clinically significant;

Egyéb

• Participants who cannot tolerate subcutaneous injection;
• Women who were pregnant or lactating or had a positive pregnancy test result;

• 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;