Birch Pollen Allergy
Conditions
Brief summary
Randomized, double-blind placebo-controlled phase I study to investigate the safety and tolerability of ascending doses of DM-101 in adult subjects with birch pollen allergy.
Detailed description
The study will be carried out in a single study site located in Finland.
Interventions
BIOLOGICALDM-101
DM-101 administered by subcutaneous (SC) injection
BIOLOGICALPlacebo to match DM-101
Placebo to match DM-101 administered by SC injection
Sponsors
Desentum Oy
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Intervention model description
4 sequential study cohorts with ascending DM-101 doses. In each cohort two treatment arms: placebo and active drug
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Males or females, aged 18 to 65 years * Good general health * A documented clinical history of birch pollen-induced allergic rhinitis or rhinoconjunctivitis with symptoms that interfere with daily activities or sleep and remain bothersome despite the use of relevant symptomatic medication, and have been present over, at least, 2 allergy seasons. * Bet v 1 specific serum IgE ≥ 0.7 kU/L * Positive SPT to birch pollen allergen, with a wheal diameter ≥ 5 mm * Body weight ≥50 kg and body mass index (BMI) within the range 18-35 kg/m2. Key
Exclusion criteria
* History or findings on physical examination of any significant disease or disorder which, in the opinion of the Investigator, may put the subject at risk because of participation in the study, influence the results of the study or the subject's ability to participate in the study. * Current diagnosis of asthma (other than seasonal during the birch pollen allergy season), requiring Global Initiative for Asthma (GINA) Step 2 or higher treatment, or asthma partially controlled or uncontrolled according to GINA classification in the 6 months before Screening. * History of asthma deterioration that resulted in emergency treatment or hospitalisation in the 12 months before screening, or a life-threatening asthma attack at any time in the past. * Forced Expiratory Volume in one second (FEV1) \< 70% of predicted, regardless of asthma status at screening or baseline assessment at the first dosing visit. * History of severe drug allergy, severe angioedema or systemic allergic reaction of Grade 3 or greater, according to the World Allergy Organization (WAO) scale, due to any cause.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Emergent Adverse Events | From the first dose until 28 days following the last dose. | Number of All Treatment Emergent Adverse Events (TEAEs) in Subjects Receiving DM-101 Compared to Placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo | From the first dose until 28 days following the last dose. | Severity of SARs are graded from Grade 1 to 5 (Grade 5 being fatal) as defined by WAO Subcutaneous Immunotherapy Systemic Reaction Grading System. |
| Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo | From the first dose until 28 days following the last dose. | Pain, tenderness, erythema/redness and induration/swelling at the injection site was assessed after each injection using a 4-point scale (Grade 1 = mild, Grade 4 = severe) as defined in the study protocol. |
| Subjects Reaching the Pre-defined DM-101 Dose | From the first dose until 28 days following the last dose. | Proportion of subjects reaching the pre-defined, admissible dose in each DM-101 dosing group |
Countries
Finland
Participant flow
Recruitment details
Participants were enrolled at one study site in Finland. The first participant was screened 11 February 2020. The last study visit occurred on 31 Mat 2021.
Pre-assignment details
61 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| DM-101 Single Dose Participants received a single subcutaneous (SC) dose of DM-101 30 ng on Day 1. | 4 |
| Placebo Single Dose Participants received a single SC injection of placebo on Day 1. | 2 |
| DM-101 Low Multiple Ascending Doses (MAD) Participants received 5 biweekly administered SC doses of DM-101 as follows: 30 ng on Day 1,50 ng on Day 14, 100 ng on Day 28, 42, and 56. | 6 |
| Placebo Low MAD Participants received 5 biweekly administered SC injections of placebo on Day 1,14, 28, 42, and 56. | 2 |
| DM-101 High MAD Participants received 5 biweekly administered SC doses of DM-101 as follows: 30 ng on Day 1,50 ng on Day 14, 100 ng on Day 28, 200 ng (dose divided into two SC injections) on Day 42, and 300 ng (dose divided into three SC injections) on Day 56. | 6 |
| Placebo High MAD Participants received 5 biweekly administered SC injections of placebo as follows: single injection on Day 1, 14 and 28; two injections on Day 42; three injections on Day 56. | 2 |
| DM-101 2-Day Ultra-Rush Dose Escalation Participants received 9 SC doses of DM-101 as follows: 100, 250, 500, 1000, 2500, 5000, 10000 and 25000 ng during Day 1 and Day 2. | 4 |
| Placebo 2-Day Ultra-Rush Dose Escalation Participants received 9 SC injections of placebo during Day 1 and Day 2. | 1 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 0 | 1 | 0 | 2 | 0 |
| Overall Study | Onset of birch pollen season | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | temporary halt of the study | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 |
Baseline characteristics
| Characteristic | Placebo Single Dose | DM-101 Single Dose | DM-101 Low Multiple Ascending Doses (MAD) | Placebo Low MAD | DM-101 High MAD | Placebo High MAD | DM-101 2-Day Ultra-Rush Dose Escalation | Placebo 2-Day Ultra-Rush Dose Escalation | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 27.5 years STANDARD_DEVIATION 4.95 | 39.3 years STANDARD_DEVIATION 10.81 | 29.8 years STANDARD_DEVIATION 11.34 | 26.5 years STANDARD_DEVIATION 4.95 | 37.7 years STANDARD_DEVIATION 8.43 | 34.5 years STANDARD_DEVIATION 7.78 | 44.0 years STANDARD_DEVIATION 5.03 | 33.0 years STANDARD_DEVIATION 0 | 31.11 years STANDARD_DEVIATION 9.42 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 4 Participants | 6 Participants | 2 Participants | 6 Participants | 2 Participants | 4 Participants | 1 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 2 Participants | 4 Participants | 6 Participants | 2 Participants | 6 Participants | 2 Participants | 4 Participants | 1 Participants | 27 Participants |
| Region of Enrollment Finland | 2 participants | 4 participants | 6 participants | 2 participants | 6 participants | 2 participants | 4 participants | 1 participants | 27 participants |
| Sex: Female, Male Female | 0 Participants | 2 Participants | 5 Participants | 2 Participants | 2 Participants | 1 Participants | 2 Participants | 1 Participants | 15 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 1 Participants | 0 Participants | 4 Participants | 1 Participants | 2 Participants | 0 Participants | 12 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 | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 2 | 0 / 6 | 0 / 2 | 0 / 6 | 0 / 2 | 0 / 4 | 0 / 1 |
| other Total, other adverse events | 4 / 4 | 2 / 2 | 6 / 6 | 2 / 2 | 6 / 6 | 2 / 2 | 4 / 4 | 1 / 1 |
| serious Total, serious adverse events | 0 / 4 | 0 / 2 | 1 / 6 | 0 / 2 | 0 / 6 | 0 / 2 | 0 / 4 | 0 / 1 |
Outcome results
Primary
Treatment Emergent Adverse Events
Number of All Treatment Emergent Adverse Events (TEAEs) in Subjects Receiving DM-101 Compared to Placebo
Time frame: From the first dose until 28 days following the last dose.
Population: The Safety Set included participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DM-101 Single Dose | Treatment Emergent Adverse Events | 13 number of adverse events per arm |
| Placebo Single Dose | Treatment Emergent Adverse Events | 3 number of adverse events per arm |
| DM-101 Low Multiple Ascending Doses (MAD) | Treatment Emergent Adverse Events | 81 number of adverse events per arm |
| Placebo Low MAD | Treatment Emergent Adverse Events | 2 number of adverse events per arm |
| DM-101 High MAD | Treatment Emergent Adverse Events | 88 number of adverse events per arm |
| Placebo High MAD | Treatment Emergent Adverse Events | 7 number of adverse events per arm |
| DM-101 2-Day Ultra-Rush Dose Escalation | Treatment Emergent Adverse Events | 72 number of adverse events per arm |
| Placebo 2-Day Ultra-Rush Dose Escalation | Treatment Emergent Adverse Events | 2 number of adverse events per arm |
Comparison: No statistical analyses were performed.
Secondary
Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo
Pain, tenderness, erythema/redness and induration/swelling at the injection site was assessed after each injection using a 4-point scale (Grade 1 = mild, Grade 4 = severe) as defined in the study protocol.
Time frame: From the first dose until 28 days following the last dose.
Population: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DM-101 Single Dose | Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo | Grade 1 | 4 number of LISRs per arm |
| DM-101 Single Dose | Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo | Grade 4 | 0 number of LISRs per arm |
| DM-101 Single Dose | Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo | Grade 3 | 0 number of LISRs per arm |
| DM-101 Single Dose | Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo | Grade 2 | 0 number of LISRs per arm |
| Placebo Single Dose | Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo | Grade 1 | 0 number of LISRs per arm |
| Placebo Single Dose | Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo | Grade 3 | 0 number of LISRs per arm |
| Placebo Single Dose | Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo | Grade 4 | 0 number of LISRs per arm |
| Placebo Single Dose | Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo | Grade 2 | 0 number of LISRs per arm |
| DM-101 Low Multiple Ascending Doses (MAD) | Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo | Grade 3 | 0 number of LISRs per arm |
| DM-101 Low Multiple Ascending Doses (MAD) | Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo | Grade 2 | 0 number of LISRs per arm |
| DM-101 Low Multiple Ascending Doses (MAD) | Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo | Grade 1 | 26 number of LISRs per arm |
| DM-101 Low Multiple Ascending Doses (MAD) | Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo | Grade 4 | 0 number of LISRs per arm |
| Placebo Low MAD | Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo | Grade 2 | 0 number of LISRs per arm |
| Placebo Low MAD | Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo | Grade 3 | 0 number of LISRs per arm |
| Placebo Low MAD | Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo | Grade 1 | 1 number of LISRs per arm |
| Placebo Low MAD | Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo | Grade 4 | 0 number of LISRs per arm |
| DM-101 High MAD | Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo | Grade 4 | 0 number of LISRs per arm |
| DM-101 High MAD | Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo | Grade 3 | 0 number of LISRs per arm |
| DM-101 High MAD | Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo | Grade 1 | 27 number of LISRs per arm |
| DM-101 High MAD | Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo | Grade 2 | 8 number of LISRs per arm |
| Placebo High MAD | Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo | Grade 3 | 0 number of LISRs per arm |
| Placebo High MAD | Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo | Grade 1 | 0 number of LISRs per arm |
| Placebo High MAD | Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo | Grade 2 | 0 number of LISRs per arm |
| Placebo High MAD | Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo | Grade 4 | 0 number of LISRs per arm |
| DM-101 2-Day Ultra-Rush Dose Escalation | Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo | Grade 1 | 3 number of LISRs per arm |
| DM-101 2-Day Ultra-Rush Dose Escalation | Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo | Grade 3 | 3 number of LISRs per arm |
| DM-101 2-Day Ultra-Rush Dose Escalation | Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo | Grade 2 | 12 number of LISRs per arm |
| DM-101 2-Day Ultra-Rush Dose Escalation | Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo | Grade 4 | 0 number of LISRs per arm |
| Placebo 2-Day Ultra-Rush Dose Escalation | Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo | Grade 4 | 0 number of LISRs per arm |
| Placebo 2-Day Ultra-Rush Dose Escalation | Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo | Grade 1 | 0 number of LISRs per arm |
| Placebo 2-Day Ultra-Rush Dose Escalation | Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo | Grade 2 | 0 number of LISRs per arm |
| Placebo 2-Day Ultra-Rush Dose Escalation | Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo | Grade 3 | 0 number of LISRs per arm |
Secondary
Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo
Severity of SARs are graded from Grade 1 to 5 (Grade 5 being fatal) as defined by WAO Subcutaneous Immunotherapy Systemic Reaction Grading System.
Time frame: From the first dose until 28 days following the last dose.
Population: The Safety Analysis Set included participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DM-101 Single Dose | Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo | Grade 5 | 0 number of systemic reactions per arm |
| DM-101 Single Dose | Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo | Grade 3 | 0 number of systemic reactions per arm |
| DM-101 Single Dose | Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo | Grade 4 | 0 number of systemic reactions per arm |
| DM-101 Single Dose | Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo | Grade 1 | 0 number of systemic reactions per arm |
| DM-101 Single Dose | Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo | Grade 2 | 0 number of systemic reactions per arm |
| Placebo Single Dose | Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo | Grade 3 | 0 number of systemic reactions per arm |
| Placebo Single Dose | Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo | Grade 5 | 0 number of systemic reactions per arm |
| Placebo Single Dose | Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo | Grade 4 | 0 number of systemic reactions per arm |
| Placebo Single Dose | Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo | Grade 2 | 0 number of systemic reactions per arm |
| Placebo Single Dose | Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo | Grade 1 | 0 number of systemic reactions per arm |
| DM-101 Low Multiple Ascending Doses (MAD) | Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo | Grade 5 | 0 number of systemic reactions per arm |
| DM-101 Low Multiple Ascending Doses (MAD) | Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo | Grade 2 | 0 number of systemic reactions per arm |
| DM-101 Low Multiple Ascending Doses (MAD) | Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo | Grade 3 | 0 number of systemic reactions per arm |
| DM-101 Low Multiple Ascending Doses (MAD) | Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo | Grade 4 | 0 number of systemic reactions per arm |
| DM-101 Low Multiple Ascending Doses (MAD) | Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo | Grade 1 | 2 number of systemic reactions per arm |
| Placebo Low MAD | Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo | Grade 1 | 0 number of systemic reactions per arm |
| Placebo Low MAD | Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo | Grade 4 | 0 number of systemic reactions per arm |
| Placebo Low MAD | Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo | Grade 5 | 0 number of systemic reactions per arm |
| Placebo Low MAD | Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo | Grade 3 | 0 number of systemic reactions per arm |
| Placebo Low MAD | Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo | Grade 2 | 0 number of systemic reactions per arm |
| DM-101 High MAD | Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo | Grade 2 | 0 number of systemic reactions per arm |
| DM-101 High MAD | Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo | Grade 5 | 0 number of systemic reactions per arm |
| DM-101 High MAD | Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo | Grade 3 | 0 number of systemic reactions per arm |
| DM-101 High MAD | Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo | Grade 4 | 0 number of systemic reactions per arm |
| DM-101 High MAD | Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo | Grade 1 | 0 number of systemic reactions per arm |
| Placebo High MAD | Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo | Grade 4 | 0 number of systemic reactions per arm |
| Placebo High MAD | Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo | Grade 2 | 0 number of systemic reactions per arm |
| Placebo High MAD | Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo | Grade 3 | 0 number of systemic reactions per arm |
| Placebo High MAD | Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo | Grade 1 | 0 number of systemic reactions per arm |
| Placebo High MAD | Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo | Grade 5 | 0 number of systemic reactions per arm |
| DM-101 2-Day Ultra-Rush Dose Escalation | Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo | Grade 5 | 0 number of systemic reactions per arm |
| DM-101 2-Day Ultra-Rush Dose Escalation | Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo | Grade 1 | 0 number of systemic reactions per arm |
| DM-101 2-Day Ultra-Rush Dose Escalation | Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo | Grade 3 | 1 number of systemic reactions per arm |
| DM-101 2-Day Ultra-Rush Dose Escalation | Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo | Grade 2 | 2 number of systemic reactions per arm |
| DM-101 2-Day Ultra-Rush Dose Escalation | Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo | Grade 4 | 0 number of systemic reactions per arm |
| Placebo 2-Day Ultra-Rush Dose Escalation | Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo | Grade 5 | 0 number of systemic reactions per arm |
| Placebo 2-Day Ultra-Rush Dose Escalation | Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo | Grade 1 | 0 number of systemic reactions per arm |
| Placebo 2-Day Ultra-Rush Dose Escalation | Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo | Grade 2 | 0 number of systemic reactions per arm |
| Placebo 2-Day Ultra-Rush Dose Escalation | Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo | Grade 4 | 0 number of systemic reactions per arm |
| Placebo 2-Day Ultra-Rush Dose Escalation | Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo | Grade 3 | 0 number of systemic reactions per arm |
Secondary
Subjects Reaching the Pre-defined DM-101 Dose
Proportion of subjects reaching the pre-defined, admissible dose in each DM-101 dosing group
Time frame: From the first dose until 28 days following the last dose.
Population: The Safety Analysis Set included participants who received at least 1 dose of study drug
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DM-101 Single Dose | Subjects Reaching the Pre-defined DM-101 Dose | 4 Participants |
| Placebo Single Dose | Subjects Reaching the Pre-defined DM-101 Dose | 5 Participants |
| DM-101 Low Multiple Ascending Doses (MAD) | Subjects Reaching the Pre-defined DM-101 Dose | 4 Participants |
| Placebo Low MAD | Subjects Reaching the Pre-defined DM-101 Dose | 0 Participants |