A Study of QLS1128 and in Combination With Ritonavir in Healthy Participants

A Phase 1, Randomized, Double-blind, Single-and Multiple-dose Escalation, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of QLS1128 and in Combination With Ritonavir in Healthy Participants

A study to evaluate safety, tolerability and pharmacokinetics of QLS1128 sustained-release tablets and in combination with ritonavir tablets in healthy participants

Inclusion Criteria:

• Healthy male or female subjects between ages of 18-45 years.
• Male subjects' weight ≥ 50 kg, female subjects' weight ≥ 45 kg; body mass index ≥ 19 kg/m2 and ≤ 27 kg/m2.
• Female participants of child-bearing potential/ Male subjects had fertile female partners must agree to use effective contraception from screening until 30 days after last dose.

Exclusion Criteria:

• Participant who have a past history of COVID-19 infection or are currently showing symptoms of COVID-19 infection.
• Participant who have been treated with any SARS-COV-2 neutralizing antibody or participated in clinical trials related to SARS-COV-2 (e.g., SARS-COV-2 neutralizing antibody, oral drug clinical trials, etc.).
• Participant who tested positive for SARS-COV-2 nucleic acid during the screening period, or who were positive for COVID-19 antibody if not vaccinated against COVID-19.
• Participant who have a clear history of allergy to drugs, food or pollen, or are allergic to ritonavir tablets and QLS1128 sustained-release tablets.
• Any clinical serious disease of cardiovascular, endocrine, neurological, digestive, respiratory, hematological, metabolic, psychiatric or other systems determined by the investigator may interfere with the results of this clinical trial.