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

Sponsor
Qilu Pharmaceutical Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05458076
Collaborator
(none)
86
Enrollment
1
Location
3
Arms
2.1
Anticipated Duration (Months)
40.3
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: QLS1128 A-Dose 1~5 and Ritonavir
  • Drug: QLS1128 C-Dose 1~3 and Ritonavir
  • Drug: QLS1128 D-Dose 1 and Ritonavir
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
86 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jul 3, 2022
Anticipated Primary Completion Date :
Sep 6, 2022
Anticipated Study Completion Date :
Sep 6, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. The PK parameters of QLS1128 [Day 1 to Day 3]

    Estimate of steady state Cmax for single dose administration of QLS1128

Other Outcome Measures

  1. The PK parameters of QLS1128 [Day 1 to Day 3]

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

  2. The PK parameters of QLS1128 [Day 1 up to Day 7]

    Estimate of steady state Cmax for multiple dose administration of QLS1128

  3. The PK parameters of QLS1128 [Day 1 up to Day 7]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
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:

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Qilu Pharmaceutical Co., Ltd. Jinan Shandong China 10000

Sponsors and Collaborators

  • Qilu Pharmaceutical Co., Ltd.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Qilu Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05458076
Other Study ID Numbers:
  • QLS1128-101
First Posted:
Jul 14, 2022
Last Update Posted:
Jul 14, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Ritonavir

Study Results

No Results Posted as of Jul 14, 2022