A Study of QLS1128 and in Combination With Ritonavir in Healthy Participants
NCT ID: NCT05458076
Last Updated: 2022-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1
86 participants
INTERVENTIONAL
2022-07-03
2022-09-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Compare QLS1128 With Placebo in Symptomatic Participants With Mild to Moderate COVID-19
NCT05758519
A Phase 2 Study to Evaluate the Efficacy and Safety of QLS1128 Orally in Symptomatic Participants With Mild to Moderate COVID-19
NCT05689203
A Clinical Study to Evaluate the Efficacy and Safety of SIM0417 Orally Co-Administered With Ritonavir in Symptomatic Adult Participants With Mild to Moderate COVID-19
NCT05506176
Study of RAY1216 Tablets Compared With Placebo in Patients With Mild to Moderate COVID-19
NCT05620160
A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection
NCT05047601
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
QLS1128 A-Dose 1~5
single dose
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
Twice daily for 7 days
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
fasting，high fat meal
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
18 Years
45 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Qilu Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
yunfei ju, M.D.
Role: STUDY_DIRECTOR
Qilu Pharmaceutical Co., Ltd.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Qilu Pharmaceutical Co., Ltd.
Jinan, Shandong, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
QLS1128-101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.