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

Study Overview

• Status: Recruiting
• Conditions: COVID-19
• Intervention / Treatment: Drug: QLS1128 A-Dose 1~5 and Ritonavir; Drug: QLS1128 C-Dose 1~3 and Ritonavir; Drug: QLS1128 D-Dose 1 and Ritonavir

• Study Type: Interventional
• Enrollment (Anticipated): 86
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: yunfei ju, M.D.; Phone Number: 15053185458; Email: yunfei.ju@qilu-pharma.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 10000
      • Recruiting
      • Qilu Pharmaceutical Co., Ltd.
      • Contact: yunfei ju, M.D.; Phone Number: 15053185458; Email: yunfei.ju@qilu-pharma.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QLS1128 A-Dose 1~5; single dose	Drug: QLS1128 A-Dose 1~5 and Ritonavir; Cohort 1: QLS1128 A-Dose 1 or Placebo Cohort 2: Period 1: QLS1128 A-Dose 2 or Placebo, on day 1. Period 2:QLS1128 A-Dose 2 or Placebo with high fat meal on day 5. Period 3:QLS1128 A-Dose 2 or Placebo plus Ritonavir on day 9 Cohort 3: QLS1128 A-Dose 3 or Placebo Cohort 4: QLS1128 A-Dose 4 or Placebo Cohort 5: QLS1128 A-Dose 5 or Placebo
Experimental: QLS1128 C-Dose 1~3; Twice daily for 7 days	Drug: QLS1128 C-Dose 1~3 and Ritonavir; Cohort 6: Period 1: QLS1128 C-Dose 1 or Placebo, twice daily for 7 days. Period 2:QLS1128 C-Dose 1 or Placebo plus Ritonavir , twice daily for 7 days Cohort 7: Period 1: QLS1128 C-Dose 2 or Placebo, twice daily for 7 days. Period 2:QLS1128 C-Dose 2 or Placebo plus Ritonavir , twice daily for 7 days Cohort 8: Period 1: QLS1128 C-Dose 3 or Placebo, twice daily for 7 days. Period 2:QLS1128 C-Dose 3 or Placebo plus Ritonavir , twice daily for 7 days
Experimental: QLS1128 D-Dose 1; fasting，high fat meal	Drug: QLS1128 D-Dose 1 and Ritonavir; Cohort 9: Group A:QLS1128 D-Dose 1 plus Ritonavir under fasting condition, on day 1. QLS1128 D-Dose 1 plus Ritonavir under fatty food condition, on day 5 Group B: QLS1128 D-Dose 1 plus Ritonavir under fatty food condition , on day 1. QLS1128 D-Dose 1 plus Ritonavir under fasting condition, on day 5

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The PK parameters of QLS1128	Estimate of steady state Cmax for single dose administration of QLS1128	Day 1 to Day 3

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The PK parameters of QLS1128	Estimate of steady state AUC0-t for single dose administration of QLS1128	Day 1 to Day 3
The PK parameters of QLS1128	Estimate of steady state Cmax for multiple dose administration of QLS1128	Day 1 up to Day 7
The PK parameters of QLS1128	Estimate of steady state AUC0-t for multiple dose administration of QLS1128	Day 1 up to Day 7

Collaborators and Investigators

• Sponsor: Qilu Pharmaceutical Co., Ltd.
• Investigators: Study Director: yunfei ju, M.D., Qilu Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2022
• Primary Completion (Anticipated): September 6, 2022
• Study Completion (Anticipated): September 6, 2022

Study Registration Dates

• First Submitted: July 6, 2022
• First Submitted That Met QC Criteria: July 11, 2022
• First Posted (Actual): July 14, 2022

Study Record Updates

• Last Update Posted (Actual): July 14, 2022
• Last Update Submitted That Met QC Criteria: July 11, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Ritonavir
• Other Study ID Numbers: QLS1128-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No