Trial Outcomes & Findings for 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 (NCT NCT05677893)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

44 participants

Primary outcome timeframe

1 month

Results posted on

2025-03-30

Participant Flow

Participant milestones

Participant milestones
Measure	Investigational Drug, 0.3 mg/kg, Part A (SAD) Eligible participants will be assigned to receive a 0.3 mg/kg single dose of the investigational drug. MBS-COV: MBS-COV is a potent siRNA treatment for mild to moderate COVID-19.	Investigational Drug, 0.6 mg/kg, Part A (SAD) Eligible participants will be assigned to receive a 0.6 mg/kg single dose of the investigational drug. MBS-COV: MBS-COV is a potent siRNA treatment for mild to moderate COVID-19.	Investigational Drug, 1.2 mg/kg, Part A (SAD) Eligible participants will be assigned to receive a 1.2 mg/kg single dose of the investigational drug. MBS-COV: MBS-COV is a potent siRNA treatment for mild to moderate COVID-19.	Placebo, Part A (SAD) Eligible participants will be assigned to single doses of the placebo. Placebo: Normal saline	Investigational Drug, 0.6 mg/kg, Part B (MAD) Eligible participants will be assigned to receive 0.6 mg/kg multiple doses of the investigational drug, once daily for 7 consecutive days. MBS-COV: MBS-COV is a potent siRNA treatment for mild to moderate COVID-19.	Investigational Drug, 1.2 mg/kg, Part B (MAD) Eligible participants will be assigned to receive 1.2 mg/kg multiple doses of the investigational drug, once daily for 7 consecutive days. MBS-COV: MBS-COV is a potent siRNA treatment for mild to moderate COVID-19.	Placebo, Part B (MAD) Eligible participants will be assigned to multiple doses of the placebo, once daily for 7 consecutive days. Placebo: Normal saline
Overall Study STARTED	6	6	6	6	8	8	4
Overall Study COMPLETED	5	6	6	6	7	7	4
Overall Study NOT COMPLETED	1	0	0	0	1	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Investigational Drug, 0.3 mg/kg, Part A (SAD) Eligible participants will be assigned to receive a 0.3 mg/kg single dose of the investigational drug. MBS-COV: MBS-COV is a potent siRNA treatment for mild to moderate COVID-19.	Investigational Drug, 0.6 mg/kg, Part A (SAD) Eligible participants will be assigned to receive a 0.6 mg/kg single dose of the investigational drug. MBS-COV: MBS-COV is a potent siRNA treatment for mild to moderate COVID-19.	Investigational Drug, 1.2 mg/kg, Part A (SAD) Eligible participants will be assigned to receive a 1.2 mg/kg single dose of the investigational drug. MBS-COV: MBS-COV is a potent siRNA treatment for mild to moderate COVID-19.	Placebo, Part A (SAD) Eligible participants will be assigned to single doses of the placebo. Placebo: Normal saline	Investigational Drug, 0.6 mg/kg, Part B (MAD) Eligible participants will be assigned to receive 0.6 mg/kg multiple doses of the investigational drug, once daily for 7 consecutive days. MBS-COV: MBS-COV is a potent siRNA treatment for mild to moderate COVID-19.	Investigational Drug, 1.2 mg/kg, Part B (MAD) Eligible participants will be assigned to receive 1.2 mg/kg multiple doses of the investigational drug, once daily for 7 consecutive days. MBS-COV: MBS-COV is a potent siRNA treatment for mild to moderate COVID-19.	Placebo, Part B (MAD) Eligible participants will be assigned to multiple doses of the placebo, once daily for 7 consecutive days. Placebo: Normal saline
Overall Study Withdrawal by Subject	0	0	0	0	1	1	0
Overall Study Others	1	0	0	0	0	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Investigational Drug, 0.3 mg/kg, Part A (SAD) n=6 Participants 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.	Investigational Drug, 0.6 mg/kg, Part A (SAD) n=6 Participants 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.	Investigational Drug, 1.2 mg/kg, Part A (SAD) n=6 Participants 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.	Placebo, Part A (SAD) n=6 Participants Eligible participants will be assigned to single doses of the placebo. Placebo: Normal saline	Investigational Drug, 0.6 mg/kg, Part B (MAD) n=8 Participants 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.	Investigational Drug, 1.2 mg/kg, Part B (MAD) n=8 Participants 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.	Placebo, Part B (MAD) n=4 Participants Eligible participants will be assigned to multiple doses of the placebo. Placebo: Normal saline	Total n=44 Participants Total of all reporting groups
Age, Customized	37.67 years STANDARD_DEVIATION 9.09 • n=93 Participants	38.83 years STANDARD_DEVIATION 7.47 • n=4 Participants	30.83 years STANDARD_DEVIATION 6.8 • n=27 Participants	31.83 years STANDARD_DEVIATION 10.5 • n=483 Participants	35.13 years STANDARD_DEVIATION 5.38 • n=36 Participants	36.38 years STANDARD_DEVIATION 9.61 • n=10 Participants	37.5 years STANDARD_DEVIATION 8.89 • n=115 Participants	36.1 years STANDARD_DEVIATION 7.62 • n=40 Participants
Sex: Female, Male Female	1 Participants n=93 Participants	1 Participants n=4 Participants	4 Participants n=27 Participants	0 Participants n=483 Participants	2 Participants n=36 Participants	4 Participants n=10 Participants	0 Participants n=115 Participants	12 Participants n=40 Participants
Sex: Female, Male Male	5 Participants n=93 Participants	5 Participants n=4 Participants	2 Participants n=27 Participants	6 Participants n=483 Participants	6 Participants n=36 Participants	4 Participants n=10 Participants	4 Participants n=115 Participants	32 Participants n=40 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 Participants n=93 Participants	3 Participants n=4 Participants	3 Participants n=27 Participants	1 Participants n=483 Participants	1 Participants n=36 Participants	2 Participants n=10 Participants	1 Participants n=115 Participants	12 Participants n=40 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	5 Participants n=93 Participants	3 Participants n=4 Participants	3 Participants n=27 Participants	5 Participants n=483 Participants	7 Participants n=36 Participants	6 Participants n=10 Participants	3 Participants n=115 Participants	32 Participants n=40 Participants
Region of Enrollment United States	6 participants n=93 Participants	6 participants n=4 Participants	6 participants n=27 Participants	6 participants n=483 Participants	8 participants n=36 Participants	8 participants n=10 Participants	4 participants n=115 Participants	44 participants n=40 Participants

PRIMARY outcome

Timeframe: 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.