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

Qilu Pharmaceutical

Status and phase: Enrolling; Phase 1

Conditions: COVID-19

Treatments: Drug: QLS1128 D-Dose 1 and Ritonavir; Drug: QLS1128 A-Dose 1~5 and Ritonavir; Drug: QLS1128 C-Dose 1~3 and Ritonavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT05458076

QLS1128-101

Details and patient eligibility

About

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

Enrollment: 86 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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86 participants in 3 patient groups

QLS1128 A-Dose 1~5

Experimental group

Description:

single dose

Treatment:

Drug: QLS1128 A-Dose 1~5 and Ritonavir

QLS1128 C-Dose 1~3

Experimental group

Description:

Twice daily for 7 days

Treatment:

Drug: QLS1128 C-Dose 1~3 and Ritonavir

QLS1128 D-Dose 1

Experimental group

Description:

fasting，high fat meal

Treatment:

Drug: QLS1128 D-Dose 1 and Ritonavir