Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a Phase I double-blind, randomized, placebo-controlled study in 250 healthy adults, 18-49 years of age, inclusive, who are in good health and meet all eligibility criteria. The purpose of this dose escalation clinical study is to assess the safety, tolerability/reactogenicity, and immunogenicity of H3N2 M2SR investigational vaccines for prevention of influenza, when delivered at higher dosages or in two doses . Eligible subjects will be screened and randomized to receive two administrations 28 days apart of Sing2016 M2SR at three dose levels (low, medium, high), Bris10 M2SR at one dose level (low), or placebo in a 1:1:1:1:1 ratio. Study duration will be approximately 8 months with subject participation duration approximately 7 months. The primary study objective is to assess the safety and reactogenicity of a monovalent live single replication influenza H3N2 M2SR vaccine.
This is a Phase I double-blind, randomized, placebo-controlled study in 250 healthy adults, 18-49 years of age, inclusive, who are in good health and meet all eligibility criteria. This dose escalation clinical study is designed to assess the safety, tolerability/reactogenicity, and immunogenicity of H3N2 M2SR investigational vaccines for prevention of influenza, when delivered at increasing dosages or in two doses. Subjects will be enrolled in five groups in a 1:1:1:1:1 ratio. Arm 1 will receive a low dose of Sing2016 M2SR intranasally on days 1 and 29. Arm 2 will receive a medium dose of Sing2016 M2SR intranasally on days 1 and 29. Arm 3 will receive a high dose of Sing2016 M2SR intranasally on days 1 and 29. Arm 4 will receive a low dose of Bris16 M2SR intranasally on days 1 and 29. Arm 5 will receive a placebo intranasally on days 1 and 29. Study duration will be approximately 8 months with subject participation duration approximately 7 months. The primary study objective is to assess the safety and reactogenicity of a monovalent live single replication influenza H3N2 M2SR vaccine. The secondary study objectives are to evaluate systemic and mucosal immune responses induced by H3N2 M2SR vaccination.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose Sing2016 M2SR | Experimental | Low dose Sing2016 M2SR will be administered intranasally on days 1 and 29 |
|
| Medium dose Sing2016 M2SR | Experimental | Medium dose Sing2016 M2SR will be administered intranasally on days 1 and 29 |
|
| High dose Sing2016 M2SR | Experimental | High dose Sing2016 M2SR will be administered intranasally on days 1 and 29 |
|
| Low dose Bris10 M2SR | Active Comparator | Low dose Bris10 M2SR will be administered intranasally on days 1 and 29 |
|
| Placebo | Placebo Comparator | Saline will be administered intranasally on days 1 and 29 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LD Sing2016 M2SR H3N2 influenza vaccine | Biological | This group will receive a low dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Local and Systemic Adverse Events (AEs) Through 29 Days Post-vaccination With Bris10 M2SR and Cumulatively Through Day 209 | Record adverse events following one and two administrations of the Bris10 M2SR influenza vaccine to determine the number and percentage of study participants who experience any vaccine associated adverse events (AEs) or serious adverse events (SAEs) after Bris10 M2SR or placebo administration. | From baseline through study completion (Day 209) |
| Number of Participants With Local and Systemic Adverse Events (AEs) Through 29 Days Post-vaccination With Sing2016 M2SR and Cumulatively Through Day 209 | Record adverse events following one and two administrations of the Sing2016 M2SR influenza vaccine to determine the number and percentage of study participants who experience any vaccine associated adverse events (AEs) or serious adverse events (SAEs) after Sing2016 M2SR or placebo administration. | From baseline through study completion (Day 209) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Bris10 M2SR Subjects Demonstrating Seroconversion to Vaccine HA | Assess the humoral immunogenicity of one administration of Bris10 M2SR vaccine to Bris 10 by HAI at day 29. | From baseline through 28 days post-dose 1 (Day 29) |
| Percentage of Sing2016 M2SR Subjects Demonstrating Seroconversion to Vaccine HA |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pamuk Bilsel | FluGen Inc | Study Director |
| Carlos Fierro, MD | JCCT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RCA | Hollywood | Florida | 33024 | United States | ||
| JCCT |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36350017 | Derived | Eiden J, Fierro C, Schwartz H, Adams M, Ellis KJ, Aitchison R, Herber R, Hatta Y, Marshall D, Moser MJ, Belshe R, Greenberg H, Coelingh K, Kawaoka Y, Neumann G, Bilsel P. Intranasal M2SR (M2-Deficient Single Replication) H3N2 Influenza Vaccine Provides Enhanced Mucosal and Serum Antibodies in Adults. J Infect Dis. 2022 Dec 28;227(1):103-112. doi: 10.1093/infdis/jiac433. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Low Dose Sing2016 M2SR | Low dose Sing2016 M2SR will be administered intranasally on days 1 and 29 LD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a low dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally. |
| FG001 | Medium Dose Sing2016 M2SR |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 18, 2020 | Aug 3, 2021 |
Not provided
This is a randomized, double-blind, placebo-controlled Phase 1 study evaluating the safety and immunogenicity of the Bris10 M2SR and Sing2016 M2SR H3N2 influenza vaccines delivered intranasally to healthy adults. Eligible subjects will be screened and randomized to receive two administrations 28 days apart of Sing2016 M2SR at three dose levels, Bris10 M2SR at one dose level, or placebo in a 1:1:1:1:1 ratio.
Not provided
Not provided
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
| MD Sing2016 M2SR H3N2 influenza vaccine | Biological | This group will receive a medium dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally. |
|
| HD Sing2016 M2SR H3N2 influenza vaccine | Biological | This group will receive a high dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally. |
|
| LD Bris10 M2SR H3N2 influenza vaccine | Biological | This group will receive a low dose of the Bris10 M2SR H3N2 monovalent influenza vaccine administered intranasally. |
|
| Placebo | Other | This group will receive saline placebo administered intranasally. |
|
Assess the humoral immunogenicity of one administration of Sing2016 M2SR vaccine to Sing2016 by HAI at day 29 |
| From baseline through 28 days post-dose 1 (Day 29) |
| Percentage of Bris10 M2SR Subjects Demonstrating Seroconversion to Vaccine HA | Assess the humoral immunogenicity of two administrations of Bris10 M2SR vaccine to Bris 10 by HAI at d57. | From baseline through 28 days post-dose 2 (Day 57) |
| Percentage of Sing2016 M2SR Subjects Demonstrating Seroconversion to Vaccine HA | Assess the humoral immunogenicity of two administrations of Sing2016 M2SR vaccine to Sing2016 by HAI at day 57 | From baseline through 28 days post-dose 2 (Day 57) |
| Percentage of Bris10 M2SR Subjects Demonstrating Mucosal Responses to Vaccine HA | Assess the mucosal immunogenicity of one administration of Bris10 M2SR vaccine to Bris 10 by ELISA at day 29. | From baseline through 28 days post-dose 1 (Day 29) |
| Percentage of Bris10 M2SR Subjects Demonstrating Mucosal Responses to Vaccine HA | Assess the mucosal immunogenicity of two administrations of Bris10 M2SR vaccine to Bris 10 by ELISA at day 57. | From baseline through 28 days post-dose 2 (Day 57) |
| Percentage of Sing2016 M2SR Subjects Demonstrating Mucosal Responses to Vaccine HA | Assess the mucosal immunogenicity of two administrations of Sing2016 M2SR vaccine to Sing2016 by ELISA at day 57 | From baseline through 28 days post-dose 2 (Day 57) |
| Percentage of Sing2016 M2SR Subjects Demonstrating Mucosal Responses to Vaccine HA | Assess the mucosal immunogenicity of one administration of Sing2016 M2SR vaccine to Sing2016 by ELISA at day 29 | From baseline through 28 days post-dose 1 (Day 29) |
| Lenexa |
| Kansas |
| 66219 |
| United States |
| AMR Lexington | Lexington | Kentucky | 40509 | United States |
| AMR Norfolk | Norfolk | Virginia | 23507 | United States |
Medium dose Sing2016 M2SR will be administered intranasally on days 1 and 29 MD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a medium dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally. |
| FG002 | High Dose Sing2016 M2SR | High dose Sing2016 M2SR will be administered intranasally on days 1 and 29 HD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a high dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally. |
| FG003 | Low Dose Bris10 M2SR | Low dose Bris10 M2SR will be administered intranasally on days 1 and 29 LD Bris10 M2SR H3N2 influenza vaccine: This group will receive a low dose of the Bris10 M2SR H3N2 monovalent influenza vaccine administered intranasally. |
| FG004 | Placebo | Saline will be administered intranasally on days 1 and 29 Placebo: This group will receive saline placebo administered intranasally. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Low Dose Sing2016 M2SR | Low dose Sing2016 M2SR will be administered intranasally on days 1 and 29 LD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a low dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally. |
| BG001 | Medium Dose Sing2016 M2SR | Medium dose Sing2016 M2SR will be administered intranasally on days 1 and 29 MD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a medium dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally. |
| BG002 | High Dose Sing2016 M2SR | High dose Sing2016 M2SR will be administered intranasally on days 1 and 29 HD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a high dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally. |
| BG003 | Low Dose Bris10 M2SR | Low dose Bris10 M2SR will be administered intranasally on days 1 and 29 LD Bris10 M2SR H3N2 influenza vaccine: This group will receive a low dose of the Bris10 M2SR H3N2 monovalent influenza vaccine administered intranasally. |
| BG004 | Placebo | Saline will be administered intranasally on days 1 and 29 Placebo: This group will receive saline placebo administered intranasally. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Local and Systemic Adverse Events (AEs) Through 29 Days Post-vaccination With Bris10 M2SR and Cumulatively Through Day 209 | Record adverse events following one and two administrations of the Bris10 M2SR influenza vaccine to determine the number and percentage of study participants who experience any vaccine associated adverse events (AEs) or serious adverse events (SAEs) after Bris10 M2SR or placebo administration. | Study participants who received at least one inoculation were included. | Posted | Count of Participants | Participants | From baseline through study completion (Day 209) |
|
|
| |||||||||||||||||||||||||||||
| Primary | Number of Participants With Local and Systemic Adverse Events (AEs) Through 29 Days Post-vaccination With Sing2016 M2SR and Cumulatively Through Day 209 | Record adverse events following one and two administrations of the Sing2016 M2SR influenza vaccine to determine the number and percentage of study participants who experience any vaccine associated adverse events (AEs) or serious adverse events (SAEs) after Sing2016 M2SR or placebo administration. | Study participants who received at least one inoculation were included. | Posted | Count of Participants | Participants | From baseline through study completion (Day 209) |
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Bris10 M2SR Subjects Demonstrating Seroconversion to Vaccine HA | Assess the humoral immunogenicity of one administration of Bris10 M2SR vaccine to Bris 10 by HAI at day 29. | Study subjects who received at least one inoculation were included. | Posted | Number | 95% Confidence Interval | Percentage of subjects | From baseline through 28 days post-dose 1 (Day 29) |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Sing2016 M2SR Subjects Demonstrating Seroconversion to Vaccine HA | Assess the humoral immunogenicity of one administration of Sing2016 M2SR vaccine to Sing2016 by HAI at day 29 | Study subjects who received at least one inoculation were included. | Posted | Number | 95% Confidence Interval | Percentage of participants | From baseline through 28 days post-dose 1 (Day 29) |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Bris10 M2SR Subjects Demonstrating Seroconversion to Vaccine HA | Assess the humoral immunogenicity of two administrations of Bris10 M2SR vaccine to Bris 10 by HAI at d57. | Study subjects who received at least one inoculation were included. | Posted | Number | 95% Confidence Interval | Percentage of subjects | From baseline through 28 days post-dose 2 (Day 57) |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Sing2016 M2SR Subjects Demonstrating Seroconversion to Vaccine HA | Assess the humoral immunogenicity of two administrations of Sing2016 M2SR vaccine to Sing2016 by HAI at day 57 | Study subjects who received at least one inoculation were included. | Posted | Number | 95% Confidence Interval | Percentage of subjects | From baseline through 28 days post-dose 2 (Day 57) |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Bris10 M2SR Subjects Demonstrating Mucosal Responses to Vaccine HA | Assess the mucosal immunogenicity of one administration of Bris10 M2SR vaccine to Bris 10 by ELISA at day 29. | Study subjects who received at least one inoculation were included. | Posted | Number | 95% Confidence Interval | Percentage of subjects | From baseline through 28 days post-dose 1 (Day 29) |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Bris10 M2SR Subjects Demonstrating Mucosal Responses to Vaccine HA | Assess the mucosal immunogenicity of two administrations of Bris10 M2SR vaccine to Bris 10 by ELISA at day 57. | Study subjects who received at least one inoculation were included. | Posted | Number | 95% Confidence Interval | Percentage of subjects | From baseline through 28 days post-dose 2 (Day 57) |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Sing2016 M2SR Subjects Demonstrating Mucosal Responses to Vaccine HA | Assess the mucosal immunogenicity of two administrations of Sing2016 M2SR vaccine to Sing2016 by ELISA at day 57 | Study subjects who received at least one inoculation were included. | Posted | Number | 95% Confidence Interval | Percentage of subjects | From baseline through 28 days post-dose 2 (Day 57) |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Sing2016 M2SR Subjects Demonstrating Mucosal Responses to Vaccine HA | Assess the mucosal immunogenicity of one administration of Sing2016 M2SR vaccine to Sing2016 by ELISA at day 29 | Study subjects who received at least one inoculation were included. | Posted | Number | 95% Confidence Interval | Percentage of subjects | From baseline through 28 days post-dose 1 (Day 29) |
|
Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Dose Sing2016 M2SR | Low dose Sing2016 M2SR will be administered intranasally on days 1 and 29 LD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a low dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally. | 0 | 42 | 0 | 42 | 26 | 42 |
| EG001 | Medium Dose Sing2016 M2SR | Medium dose Sing2016 M2SR will be administered intranasally on days 1 and 29 MD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a medium dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally. | 0 | 41 | 0 | 41 | 29 | 41 |
| EG002 | High Dose Sing2016 M2SR | High dose Sing2016 M2SR will be administered intranasally on days 1 and 29 HD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a high dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally. | 0 | 40 | 0 | 40 | 30 | 40 |
| EG003 | Low Dose Bris10 M2SR | Low dose Bris10 M2SR will be administered intranasally on days 1 and 29 LD Bris10 M2SR H3N2 influenza vaccine: This group will receive a low dose of the Bris10 M2SR H3N2 monovalent influenza vaccine administered intranasally. | 0 | 42 | 0 | 42 | 28 | 42 |
| EG004 | Placebo | Saline will be administered intranasally on days 1 and 29 Placebo: This group will receive saline placebo administered intranasally. | 0 | 41 | 1 | 41 | 24 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment | metastatic papillary thyroid carcinoma, study day 125, not considered treatment emergent |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| upper airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| nasal pruritis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| fatigue | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| pyrexia | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| AAT increase | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| blood creatinine phosphate increase | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| blood urine | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| white blood cell increase | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| bradycardia | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| hyperkalemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
|
SPONSOR has exclusive right to publish and authorize study publications or communications. INVESTIGATOR makes no presentations/publications of the Study or its results without prior SPONSOR review and approval. SPONSOR will have 90 days to request amendments including but not limited to details that may be detrimental to its intellectual property interests or to the conduct, completion, or analysis of the results of the Study by SPONSOR or its affiliates.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pamuk Bilsel, CSO | FluGen | 6084426562 | pbilsel@flugen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 28, 2020 | Aug 2, 2021 | SAP_001.pdf |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
High dose Sing2016 M2SR will be administered intranasally on days 1 and 29
HD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a high dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.
| OG003 | Placebo | Saline will be administered intranasally on days 1 and 29 Placebo: This group will receive saline placebo administered intranasally. |
|
|
|
| OG003 | Placebo | Saline will be administered intranasally on days 1 and 29 Placebo: This group will receive saline placebo administered intranasally. |
|
|
|
| OG003 | Placebo | Saline will be administered intranasally on days 1 and 29 Placebo: This group will receive saline placebo administered intranasally. |
|
|
|
|
| OG003 | Placebo | Saline will be administered intranasally on days 1 and 29 Placebo: This group will receive saline placebo administered intranasally. |
|
|
| OG003 | Placebo | Saline will be administered intranasally on days 1 and 29 Placebo: This group will receive saline placebo administered intranasally. |
|
|