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Status unknownNCT05458076Updated Jul 14, 2022

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

A Phase 1 interventional study of QLS1128 A-Dose 1~5 and Ritonavir and QLS1128 C-Dose 1~3 and Ritonavir in COVID-19, sponsored by Qilu Pharmaceutical Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-14.

Sponsored by Qilu Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
86
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • COVID-19
03

In context

Lead sponsor

Qilu Pharmaceutical Co., Ltd. is the lead sponsor of 193 studies on the registry; 119 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
86 participants (estimated)

Study arms

  • Experimental
    QLS1128 A-Dose 1~5

    single dose

    Drug: QLS1128 A-Dose 1~5 and Ritonavir

  • Experimental
    QLS1128 C-Dose 1~3

    Twice daily for 7 days

    Drug: QLS1128 C-Dose 1~3 and Ritonavir

  • Experimental
    QLS1128 D-Dose 1

    fasting，high fat meal

    Drug: QLS1128 D-Dose 1 and Ritonavir

Interventions

  • DrugQLS1128 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

  • DrugQLS1128 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

  • DrugQLS1128 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

06

What researchers measure

Primary outcomes

  1. The Adverse events of QLS1128

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

    Time frame: Day 1 to Day 28

Secondary outcomes

  1. The PK parameters of QLS1128

    Estimate of steady state Cmax for single dose administration of QLS1128

    Time frame: Day 1 to Day 3

Other outcomes

  1. The PK parameters of QLS1128

    Estimate of steady state AUC0-t for single dose administration of QLS1128

    Time frame: Day 1 to Day 3

  2. The PK parameters of QLS1128

    Estimate of steady state Cmax for multiple dose administration of QLS1128

    Time frame: Day 1 up to Day 7

  3. The PK parameters of QLS1128

    Estimate of steady state AUC0-t for multiple dose administration of QLS1128

    Time frame: Day 1 up to Day 7

07

Study locations

1 of 1 sites recruiting
  • Qilu Pharmaceutical Co., Ltd.
    Jinan, Shandong 10000, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05458076
Lead sponsor
Qilu Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Jul 14, 2022
Start date
Jul 3, 2022
Primary completion
Sep 6, 2022 (estimated)
Completion
Sep 6, 2022 (estimated)
Last update
Jul 14, 2022

Study contacts

yunfei ju, M.D.
Contact
yunfei.ju@qilu-pharma.com
15053185458
yunfei ju, M.D.
study director · Qilu Pharmaceutical Co., Ltd.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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