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

Primary Purpose

COVID-19

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
QLS1128 A-Dose 1~5 and Ritonavir
QLS1128 C-Dose 1~3 and Ritonavir
QLS1128 D-Dose 1 and Ritonavir
Sponsored by
Qilu Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts 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.

Sites / Locations

  • Qilu Pharmaceutical Co., Ltd.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

QLS1128 A-Dose 1~5

QLS1128 C-Dose 1~3

QLS1128 D-Dose 1

Arm Description

single dose

Twice daily for 7 days

fasting，high fat meal

Outcomes

Primary Outcome Measures

The Adverse events of QLS1128
Adverse events, including type, incidence, grade (determined with reference to NCI-CTCAE V5.0)

Secondary Outcome Measures

The PK parameters of QLS1128
Estimate of steady state Cmax for single dose administration of QLS1128

Full Information

First Posted
July 6, 2022
Last Updated
July 11, 2022
Sponsor
Qilu Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05458076
Brief Title
A Study of QLS1128 and in Combination With Ritonavir in Healthy Participants
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 3, 2022 (Actual)
Primary Completion Date
September 6, 2022 (Anticipated)
Study Completion Date
September 6, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qilu Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
QLS1128 A-Dose 1~5
Arm Type
Experimental
Arm Description
single dose
Arm Title
QLS1128 C-Dose 1~3
Arm Type
Experimental
Arm Description
Twice daily for 7 days
Arm Title
QLS1128 D-Dose 1
Arm Type
Experimental
Arm Description
fasting，high fat meal
Intervention Type
Drug
Intervention Name(s)
QLS1128 A-Dose 1~5 and Ritonavir
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
QLS1128 C-Dose 1~3 and Ritonavir
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
QLS1128 D-Dose 1 and Ritonavir
Intervention Description
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
Primary Outcome Measure Information:
Title
The Adverse events of QLS1128
Description
Adverse events, including type, incidence, grade (determined with reference to NCI-CTCAE V5.0)
Time Frame
Day 1 to Day 28
Secondary Outcome Measure Information:
Title
The PK parameters of QLS1128
Description
Estimate of steady state Cmax for single dose administration of QLS1128
Time Frame
Day 1 to Day 3
Other Pre-specified Outcome Measures:
Title
The PK parameters of QLS1128
Description
Estimate of steady state AUC0-t for single dose administration of QLS1128
Time Frame
Day 1 to Day 3
Title
The PK parameters of QLS1128
Description
Estimate of steady state Cmax for multiple dose administration of QLS1128
Time Frame
Day 1 up to Day 7
Title
The PK parameters of QLS1128
Description
Estimate of steady state AUC0-t for multiple dose administration of QLS1128
Time Frame
Day 1 up to Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yunfei ju, M.D.
Phone
15053185458
Email
yunfei.ju@qilu-pharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yunfei ju, M.D.
Organizational Affiliation
Qilu Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Qilu Pharmaceutical Co., Ltd.
City
Jinan
State/Province
Shandong
ZIP/Postal Code
10000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yunfei ju, M.D.
Phone
15053185458
Email
yunfei.ju@qilu-pharma.com

12. IPD Sharing Statement

Learn more about this trial

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

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