Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (Disorder)
Conditions
Brief summary
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
Interventions
DRUGMBS-COV
MBS-COV is a potent siRNA treatment for mild to moderate COVID-19.
OTHERPlacebo
Normal saline
Sponsors
Oneness Biotech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events as Assessed by Protocol Definition of AE | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Investigational Drug, 0.3 mg/kg, Part A (SAD) Eligible participants will be assigned to receive 0.3 mg/kg single doses of the investigational drug.
MBS-COV: MBS-COV is a potent siRNA treatment for mild to moderate COVID-19. | 6 |
| Investigational Drug, 0.6 mg/kg, Part A (SAD) Eligible participants will be assigned to receive 0.6 mg/kg single doses of the investigational drug.
MBS-COV: MBS-COV is a potent siRNA treatment for mild to moderate COVID-19. | 6 |
| Investigational Drug, 1.2 mg/kg, Part A (SAD) Eligible participants will be assigned to receive 1.2 mg/kg single doses of the investigational drug.
MBS-COV: MBS-COV is a potent siRNA treatment for mild to moderate COVID-19. | 6 |
| Placebo, Part A (SAD) Eligible participants will be assigned to single doses of the placebo.
Placebo: Normal saline | 6 |
| Investigational Drug, 0.6 mg/kg, Part B (MAD) Eligible participants will be assigned to receive 0.6 mg/kg mutiple doses of the investigational drug.
MBS-COV: MBS-COV is a potent siRNA treatment for mild to moderate COVID-19. | 8 |
| Investigational Drug, 1.2 mg/kg, Part B (MAD) Eligible participants will be assigned to receive 0.6 mg/kg mutiple doses of the investigational drug.
MBS-COV: MBS-COV is a potent siRNA treatment for mild to moderate COVID-19. | 8 |
| Placebo, Part B (MAD) Eligible participants will be assigned to multiple doses of the placebo.
Placebo: Normal saline | 4 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Others | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Investigational Drug, 0.3 mg/kg, Part A (SAD) | Investigational Drug, 0.6 mg/kg, Part A (SAD) | Investigational Drug, 1.2 mg/kg, Part A (SAD) | Placebo, Part A (SAD) | Investigational Drug, 0.6 mg/kg, Part B (MAD) | Investigational Drug, 1.2 mg/kg, Part B (MAD) | Placebo, Part B (MAD) | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Customized | 37.67 years STANDARD_DEVIATION 9.09 | 38.83 years STANDARD_DEVIATION 7.47 | 30.83 years STANDARD_DEVIATION 6.8 | 31.83 years STANDARD_DEVIATION 10.5 | 35.13 years STANDARD_DEVIATION 5.38 | 36.38 years STANDARD_DEVIATION 9.61 | 37.5 years STANDARD_DEVIATION 8.89 | 36.1 years STANDARD_DEVIATION 7.62 |
| Race/Ethnicity, Customized Hispanic or Latino | 1 Participants | 3 Participants | 3 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 12 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 5 Participants | 3 Participants | 3 Participants | 5 Participants | 7 Participants | 6 Participants | 3 Participants | 32 Participants |
| Region of Enrollment United States | 6 participants | 6 participants | 6 participants | 6 participants | 8 participants | 8 participants | 4 participants | 44 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 4 Participants | 0 Participants | 2 Participants | 4 Participants | 0 Participants | 12 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 2 Participants | 6 Participants | 6 Participants | 4 Participants | 4 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 8 | 0 / 8 | 0 / 4 |
| other Total, other adverse events | 3 / 6 | 0 / 6 | 0 / 6 | 1 / 6 | 0 / 8 | 2 / 8 | 0 / 4 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 8 | 0 / 8 | 0 / 4 |
Outcome results
Primary
Number of Participants With Treatment-emergent Adverse Events as Assessed by Protocol Definition of AE
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.
Time frame: 1 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Investigational Drug, 0.3 mg/kg, Part A (SAD) | Number of Participants With Treatment-emergent Adverse Events as Assessed by Protocol Definition of AE | 3 Participants |
| Investigational Drug, 0.6 mg/kg, Part A (SAD) | Number of Participants With Treatment-emergent Adverse Events as Assessed by Protocol Definition of AE | 0 Participants |
| Investigational Drug, 1.2 mg/kg, Part A (SAD) | Number of Participants With Treatment-emergent Adverse Events as Assessed by Protocol Definition of AE | 0 Participants |
| Placebo, Part A (SAD) | Number of Participants With Treatment-emergent Adverse Events as Assessed by Protocol Definition of AE | 1 Participants |
| Investigational Drug, 0.6 mg/kg, Part B (MAD) | Number of Participants With Treatment-emergent Adverse Events as Assessed by Protocol Definition of AE | 0 Participants |
| Investigational Drug, 1.2 mg/kg, Part B (MAD) | Number of Participants With Treatment-emergent Adverse Events as Assessed by Protocol Definition of AE | 2 Participants |
| Placebo, Part B (MAD) | Number of Participants With Treatment-emergent Adverse Events as Assessed by Protocol Definition of AE | 0 Participants |