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

Phase 1

• Conditions: COVID-19
• Interventions: Drug: QLS1128 C-Dose 1~3 and Ritonavir; Drug: QLS1128 D-Dose 1 and Ritonavir; Drug: QLS1128 A-Dose 1~5 and Ritonavir

• Registration Number: NCT05458076
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-07
• Study Start: 2022-07-03
• Study First Submitted: 2022-07-06
• Study First Submitted QC: 2022-07-11
• Last Update Submitted: 2022-07-11
• Study First Posted: 2022-07-14
• Last Update Posted: 2022-07-14
• Primary Completion: 2022-09-06
• Study Completion: 2022-09-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 86

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
QLS1128 C-Dose 1~3	QLS1128 C-Dose 1~3 and Ritonavir	Twice daily for 7 days
QLS1128 D-Dose 1	QLS1128 D-Dose 1 and Ritonavir	fasting，high fat meal
QLS1128 A-Dose 1~5	QLS1128 A-Dose 1~5 and Ritonavir	single dose

Primary Outcome Measures

Name	Time	Method
The Adverse events of QLS1128	Day 1 to Day 28	Adverse events, including type, incidence, grade (determined with reference to NCI-CTCAE V5.0)

Secondary Outcome Measures

Name	Time	Method
The PK parameters of QLS1128	Day 1 to Day 3	Estimate of steady state Cmax for single dose administration of QLS1128

Trial Locations

Locations (1)

Qilu Pharmaceutical Co., Ltd.; 🇨🇳 Jinan, Shandong, China