- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05677893
A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled MBS-COV (SNS812) in Healthy Participants
July 20, 2023 updated by: Oneness Biotech Co., Ltd.
A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled MBS-COV (SNS812) in Healthy Participants
A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled MBS-COV in Healthy Participants
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yang Reo, PM
- Phone Number: 02-2703-1098
- Email: Reo.Yang@onenessbio.com.tw
Study Contact Backup
- Name: Jessica Ho, Director
- Phone Number: 02-2703-1098
- Email: Jessica.Ho@onenessbio.com.tw
Study Locations
-
-
California
-
Los Angeles, California, United States, 90630
- Phase I Unit
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Body mass index (BMI) between 18.0 and 32.0 kg/m2 (inclusive).
- No serious or chronic underlying disease which would adversely affect the study conduct and data interpretation per the investigator.
- Female participants should have negative results in serum pregnancy test at screening and negative urine pregnancy test at admission
- Participants with normal spirometry (FEV1: 90% or greater) results at screening or day -1.
- Both male and female participants and their partners of childbearing potential must agree to use two medically accepted methods of contraception.
- Participants should have normal (or abnormal but not clinically significant) laboratory results per the PI's judgement including the hematology, biochemistry, coagulation indices, and urinalysis.
- Participants should have a normal (or abnormal but not clinically significant) 12-lead ECG at screening and day -1 and chest X-ray at screening
- Participants should be willing to cooperate and able to participate in this study, comply with all protocol requirements, and sign an informed consent.
- Current non-smokers and those who have not smoked within the last 3 months. This includes the use of cigarettes, e-cigarettes, and nicotine replacement products.
- Nasopharyngeal or nasal swab sample of Participants collected for COVID-19 antigen rapid test at screening and qRT-PCR test on Day -1 should be negative.
Exclusion Criteria:
- The participant has a known history of, or a positive test result for, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) at screening.
- As reported by the participant has severe cardiovascular disease, neurological disease, hematological disease, infectious disease, mental disorder, liver disease, gastrointestinal disease, lung disease, endocrine disease, immune disease or kidney disease, or has a history of the above diseases, or other symptoms known to interfere with the absorption, distribution, metabolism, or excretion of the medicine, or other conditions that the investigator believes will increase the risk of the participant and might interfere with the study conduct and results interpretation.
- The participant has history or presence of active lung disease (i.e., asthma, chronic obstructive pulmonary disease [COPD], pulmonary fibrosis, hemoptysis, bronchiectasis) or prior intubation.
- The participant has upper respiratory infection within the 3 months prior to the first dose of study drug.
- Consumed more than 14 units of alcohol per week in the 6 months before screening (1 unit of alcohol = 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine) or have taken alcohol products in the 48 hours prior to administration, or those who have a positive alcohol breath test result at screening and day -1.
- Unwillingness to abstain from the consumption of any caffeine or alcohol-containing food or drinks that may influence the drug metabolism from 48 hours before administration.
- History of drug abuse or a positive drug abuse (barbiturates, methamphetamine, benzodiazepines, morphine/opiates, phencyclidine (PCP), amphetamines, tetrahydrocannabinol (THC), methylenedioxymethamphetamine (MDMA), cocaine, methadone, and cotinine) test result at screening and day -1.
- Female participants who are lactating.
- Use of prescription or non-prescription drugs, including vaccine within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study drug.
- The subject has received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 1 month prior to the first dose of study drug and will receive another experimental agent during the duration of this study.
- The participant has a history of frequent nose bleeding.
- Participants with known allergic reactions to the study drug or its excipients.
- The participant has an acute sinusitis or history of chronic sinusitis, a history of active allergic rhinitis (AR), history of perennial allergic rhinitis (PAR), or current seasonal allergic rhinitis (SAR), or recent viral rhinitis within 2 weeks prior to administration.
- The participant has Any nasopharyngeal abnormality that may have interfered with nasal absorption, distribution, or study-related evaluations of signs or symptoms (e.g., polyps, septal deviation).
- Blood donation of more than 400 mL within 3 months before screening or more than 200 mL within 4 weeks before screening or plan to donate blood during study period.
- Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Investigational drug
Eligible participants will be assigned to receive 0.3-1.2
mg/kg single or multiple doses of the investigational drug.
|
MBS-COV is a potent siRNA treatment for mild to moderate COVID-19.
|
Placebo Comparator: Placebo
Eligible participants will be assigned to single or multiple doses of the placebo.
|
Normal saline
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with treatment-emergent adverse events as assessed by protocol definition of AE
Time Frame: 1 month
|
Safety will be reported based on Protocol defined AEs. For the purpose of this protocol, an AE will be defined as any untoward medical occurrence in a subject during the study. |
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 7, 2022
Primary Completion (Actual)
March 30, 2023
Study Completion (Actual)
March 30, 2023
Study Registration Dates
First Submitted
November 4, 2022
First Submitted That Met QC Criteria
December 28, 2022
First Posted (Actual)
January 10, 2023
Study Record Updates
Last Update Posted (Estimated)
July 24, 2023
Last Update Submitted That Met QC Criteria
July 20, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SNS812CLCT01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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