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

NCT05458076 | Unknown Phase 1 DMC

• 1 other identifier: QLS1128-101
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The PK parameters of QLS1128

  Day 1 to Day 3

Other Outcomes (3)

• The PK parameters of QLS1128

  Day 1 to Day 3

• The PK parameters of QLS1128

  Day 1 up to Day 7

• The PK parameters of QLS1128

  Day 1 up to Day 7

Study Arms (3)

QLS1128 A-Dose 1~5

EXPERIMENTAL

single dose

Drug: QLS1128 A-Dose 1~5 and Ritonavir

QLS1128 C-Dose 1~3

EXPERIMENTAL

Twice daily for 7 days

Drug: QLS1128 C-Dose 1~3 and Ritonavir

QLS1128 D-Dose 1

EXPERIMENTAL

fasting，high fat meal

Drug: QLS1128 D-Dose 1 and Ritonavir

Interventions

QLS1128 A-Dose 1~5 and Ritonavir DRUG

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

QLS1128 A-Dose 1~5

QLS1128 C-Dose 1~3 and Ritonavir DRUG

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

QLS1128 C-Dose 1~3

QLS1128 D-Dose 1 and Ritonavir DRUG

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

QLS1128 D-Dose 1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Qilu Pharmaceutical Co., Ltd.

Jinan, Shandong, 10000, China

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Ritonavir

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• yunfei ju, M.D.

  Qilu Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

yunfei ju, M.D.

CONTACT

15053185458; yunfei.ju@qilu-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 14, 2022
• Study Start: July 3, 2022
• Primary Completion: September 6, 2022
• Study Completion: September 6, 2022
• Last Updated: July 14, 2022

Record last verified: 2022-07

Locations

CN (1)