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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05458076
• Other study ID #: QLS1128-101
• Status: Recruiting
• Phase: Phase 1
• Start date: July 3, 2022
• Est. completion date: September 6, 2022

Study information

• Verified date: July 2022
• Source: Qilu Pharmaceutical Co., Ltd.
• Contact: yunfei ju, M.D.
• Phone: 15053185458
• Email: yunfei.ju[@]qilu-pharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: September 6, 2022
• Est. primary completion date: September 6, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
China	Qilu Pharmaceutical Co., Ltd.	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The PK parameters of QLS1128	Estimate of steady state AUC0-t for single dose administration of QLS1128	Day 1 to Day 3
Other	The PK parameters of QLS1128	Estimate of steady state Cmax for multiple dose administration of QLS1128	Day 1 up to Day 7
Other	The PK parameters of QLS1128	Estimate of steady state AUC0-t for multiple dose administration of QLS1128	Day 1 up to Day 7
Primary	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	The PK parameters of QLS1128	Estimate of steady state Cmax for single dose administration of QLS1128	Day 1 to Day 3