Trial Outcomes & Findings for A Study to Determine the Safety of AV-1, an Antibody Being Developed for Treatment of Dengue, in Healthy Volunteers (NCT NCT04273217)

NCT ID: NCT04273217

Last Updated: 2022-10-31

Results Overview

Clinical laboratory abnormalities reported as TEAEs by the investigator. Clinical laboratory abnormalities were defined as any abnormal findings in analysis of hematology, serum chemistry, coagulation, and urine parameters. A TEAE was defined as any event not present before exposure to study drug or any event already present that worsened in intensity or frequency after exposure whether or not considered drug related.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 42 participants
• Primary outcome timeframe: Baseline up to Day 120 (± 5 days)
• Results posted on: 2022-10-31

Participant Flow

This was a single-center study conducted in the United States.

On the first day of dosing in all cohorts, the first group in each cohort comprised 2 sentinel participants: 1 was randomly assigned to receive AV-1 and the other was randomly assigned to receive placebo. After the Investigator reviewed the safety data from the 72-hour post-dose period for the sentinel participants, the remainder of the cohort (5 participants randomly assigned to AV-1; 1 participant randomly assigned to placebo) were dosed at least 72 hours after the sentinel participants.

Participant milestones

Measure	AV-1 30 mg Participants received a single intravenous (IV) infusion (infusion duration: 1 hour) of AV-1 30 mg (volume: 250 mL) on Day 1.	AV-1 90 mg Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 90 mg (volume: 250 mL) on Day 1.	AV-1 250 mg Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 250 mg (volume: 250 mL) on Day 1.	AV-1 500 mg Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 500 mg (volume: 250 mL) on Day 1.	AV-1 1000 mg Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 1000 mg (volume: 250 mL) on Day 1.	Placebo Participants received a single IV infusion (infusion duration: 1 hour) of placebo (volume: 250 mL) on Day 1.
Overall Study STARTED	6	6	6	6	7	11
Overall Study COMPLETED	5	6	5	6	6	9
Overall Study NOT COMPLETED	1	0	1	0	1	2

Reasons for withdrawal

Measure	AV-1 30 mg Participants received a single intravenous (IV) infusion (infusion duration: 1 hour) of AV-1 30 mg (volume: 250 mL) on Day 1.	AV-1 90 mg Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 90 mg (volume: 250 mL) on Day 1.	AV-1 250 mg Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 250 mg (volume: 250 mL) on Day 1.	AV-1 500 mg Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 500 mg (volume: 250 mL) on Day 1.	AV-1 1000 mg Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 1000 mg (volume: 250 mL) on Day 1.	Placebo Participants received a single IV infusion (infusion duration: 1 hour) of placebo (volume: 250 mL) on Day 1.
Overall Study Lost to Follow-up	0	0	0	0	0	1
Overall Study Participant non-compliance	0	0	0	0	1	0
Overall Study Positive urine drug screen	1	0	1	0	0	1

Baseline Characteristics

A Study to Determine the Safety of AV-1, an Antibody Being Developed for Treatment of Dengue, in Healthy Volunteers

Baseline characteristics by cohort

Measure	AV-1 30 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 30 mg (volume: 250 mL) on Day 1.	AV-1 90 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 90 mg (volume: 250 mL) on Day 1.	AV-1 250 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 250 mg (volume: 250 mL) on Day 1.	AV-1 500 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 500 mg (volume: 250 mL) on Day 1.	AV-1 1000 mg n=7 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 1000 mg (volume: 250 mL) on Day 1.	Placebo n=11 Participants Participants received a single IV infusion (infusion duration: 1 hour) of placebo (volume: 250 mL) on Day 1.	Total n=42 Participants Total of all reporting groups
Age, Continuous	44.7 years STANDARD_DEVIATION 6.89 • n=5 Participants	35.0 years STANDARD_DEVIATION 9.65 • n=7 Participants	35.0 years STANDARD_DEVIATION 9.72 • n=5 Participants	32.3 years STANDARD_DEVIATION 8.29 • n=4 Participants	37.0 years STANDARD_DEVIATION 13.52 • n=21 Participants	35.4 years STANDARD_DEVIATION 10.50 • n=8 Participants	36.4 years STANDARD_DEVIATION 10.20 • n=8 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	6 Participants n=8 Participants	25 Participants n=8 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	5 Participants n=8 Participants	17 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants	3 Participants n=21 Participants	5 Participants n=8 Participants	17 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants	6 Participants n=8 Participants	25 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=8 Participants	7 Participants n=8 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	6 Participants n=21 Participants	8 Participants n=8 Participants	31 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants

PRIMARY outcome

Timeframe: Baseline up to Day 120 (± 5 days)

Population: The Safety population included all participants who received any amount of the investigational product.

Clinical laboratory abnormalities reported as TEAEs by the investigator. Clinical laboratory abnormalities were defined as any abnormal findings in analysis of hematology, serum chemistry, coagulation, and urine parameters. A TEAE was defined as any event not present before exposure to study drug or any event already present that worsened in intensity or frequency after exposure whether or not considered drug related.

Outcome measures

Measure	AV-1 30 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 30 mg (volume: 250 mL) on Day 1.	AV-1 90 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 90 mg (volume: 250 mL) on Day 1.	AV-1 250 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 250 mg (volume: 250 mL) on Day 1.	AV-1 500 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 500 mg (volume: 250 mL) on Day 1.	AV-1 1000 mg n=7 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 1000 mg (volume: 250 mL) on Day 1.	Placebo n=11 Participants Participants received a single IV infusion (infusion duration: 1 hour) of placebo (volume: 250 mL) on Day 1.
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) Hematology (blood glucose increased)	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) Serum chemistry	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) Coagulation	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) Urinalysis	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline up to Day 120 (± 5 days)

Population: Participants in the Safety Population were evaluated.

A full physical examination included examination of skin; head, ears, eyes, nose, throat (HEENT); neck; thyroid; lungs; heart; cardiovascular; abdomen; lymph nodes; and musculoskeletal system/extremities. Focused examination included lungs, cardiovascular, abdomen, and skin. Investigator could perform targeted, symptom-directed physical examination. A TEAE was defined as any event not present before exposure to study drug or any event already present that worsened in intensity or frequency after exposure whether or not considered drug related.

Outcome measures

Measure	AV-1 30 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 30 mg (volume: 250 mL) on Day 1.	AV-1 90 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 90 mg (volume: 250 mL) on Day 1.	AV-1 250 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 250 mg (volume: 250 mL) on Day 1.	AV-1 500 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 500 mg (volume: 250 mL) on Day 1.	AV-1 1000 mg n=7 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 1000 mg (volume: 250 mL) on Day 1.	Placebo n=11 Participants Participants received a single IV infusion (infusion duration: 1 hour) of placebo (volume: 250 mL) on Day 1.
Number of Participants With Physical Examination Abnormalities Reported as TEAEs Abdomen	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Physical Examination Abnormalities Reported as TEAEs Cardiovascular	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Physical Examination Abnormalities Reported as TEAEs Musculoskeletal system/extremities	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Physical Examination Abnormalities Reported as TEAEs Heart	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Physical Examination Abnormalities Reported as TEAEs HEENT	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Physical Examination Abnormalities Reported as TEAEs Lungs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Physical Examination Abnormalities Reported as TEAEs Lymph nodes	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Physical Examination Abnormalities Reported as TEAEs Neck	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Physical Examination Abnormalities Reported as TEAEs Skin (dermatitis contact)	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Physical Examination Abnormalities Reported as TEAEs Thyroid	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline up to Day 120 (± 5 days)

Population: Participants in the Safety Population were analyzed.

Vital sign measurements included systolic and diastolic blood pressure, oral body temperature, heart rate, and respiratory rate. A TEAE was defined as any event not present before exposure to study drug or any event already present that worsened in intensity or frequency after exposure whether or not considered drug related.

Outcome measures

Measure	AV-1 30 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 30 mg (volume: 250 mL) on Day 1.	AV-1 90 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 90 mg (volume: 250 mL) on Day 1.	AV-1 250 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 250 mg (volume: 250 mL) on Day 1.	AV-1 500 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 500 mg (volume: 250 mL) on Day 1.	AV-1 1000 mg n=7 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 1000 mg (volume: 250 mL) on Day 1.	Placebo n=11 Participants Participants received a single IV infusion (infusion duration: 1 hour) of placebo (volume: 250 mL) on Day 1.
Number of Participants With Vital Sign Abnormalities Reported as TEAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline up to Day 120 (± 5 days)

Population: Participants in the Safety Population were analyzed.

Number of participants with abnormal 12-lead ECG reported as a TEAE of electrocardiogram QT prolonged by the investigator. A TEAE was defined as any event not present before exposure to study drug or any event already present that worsened in intensity or frequency after exposure whether or not considered drug related.

Outcome measures

Measure	AV-1 30 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 30 mg (volume: 250 mL) on Day 1.	AV-1 90 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 90 mg (volume: 250 mL) on Day 1.	AV-1 250 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 250 mg (volume: 250 mL) on Day 1.	AV-1 500 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 500 mg (volume: 250 mL) on Day 1.	AV-1 1000 mg n=7 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 1000 mg (volume: 250 mL) on Day 1.	Placebo n=11 Participants Participants received a single IV infusion (infusion duration: 1 hour) of placebo (volume: 250 mL) on Day 1.
Number of Participants With 12-lead Electrocardiogram (ECG) Abnormalities Reported as TEAEs	2 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline up to Day 120 (± 5 days)

Population: Participants in the Safety Population were evaluated.

An adverse event (AE) was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.

An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of medicinal (investigational) product. A TEAE was defined as any event not present before exposure to study drug or any event already present that worsened in intensity or frequency after exposure.

Outcome measures

Measure	AV-1 30 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 30 mg (volume: 250 mL) on Day 1.	AV-1 90 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 90 mg (volume: 250 mL) on Day 1.	AV-1 250 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 250 mg (volume: 250 mL) on Day 1.	AV-1 500 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 500 mg (volume: 250 mL) on Day 1.	AV-1 1000 mg n=7 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 1000 mg (volume: 250 mL) on Day 1.	Placebo n=11 Participants Participants received a single IV infusion (infusion duration: 1 hour) of placebo (volume: 250 mL) on Day 1.
Number of Participants With TEAEs	3 Participants	3 Participants	0 Participants	1 Participants	4 Participants	3 Participants

PRIMARY outcome

Timeframe: Baseline up to Day 120 (± 5 days)

Population: Participants in the Safety Population were analyzed.

An AE or suspected adverse reaction was considered an SAE if, in the view of either the Investigator or Sponsor, it resulted in any of the following outcome:

• Death
• A life-threatening AE
• Inpatient hospitalization or prolongation of existing hospitalization
• a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
• A congenital anomaly/birth defect

Important medical events that did not result in death, was life-threatening, or required hospitalizations could have been considered serious when, based upon appropriate medical judgment, they jeopardized the participant and required medical or surgical intervention to prevent one of the outcomes listed in this definition.

Outcome measures

Measure	AV-1 30 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 30 mg (volume: 250 mL) on Day 1.	AV-1 90 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 90 mg (volume: 250 mL) on Day 1.	AV-1 250 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 250 mg (volume: 250 mL) on Day 1.	AV-1 500 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 500 mg (volume: 250 mL) on Day 1.	AV-1 1000 mg n=7 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 1000 mg (volume: 250 mL) on Day 1.	Placebo n=11 Participants Participants received a single IV infusion (infusion duration: 1 hour) of placebo (volume: 250 mL) on Day 1.
Number of Participants With Serious Adverse Events (SAEs)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline up to Day 120 (± 5 days)

Population: Participants in the Safety Population who experienced any AE were analyzed.

AEs were assessed by the Investigator as Mild (Grade 1), Moderate (Grade 2), or Severe (Grade 3).

Mild (Grade 1): Events that were transient and required only minimal or no treatment or therapeutic intervention and did not interfere with the participants usual activities of daily living.

Moderate (Grade 2): Events that were alleviated with additional specific therapeutic intervention. The event interfered with usual activities of daily living, causing discomfort but posed no significant or permanent risk of harm to the participant.

Severe (Grade 3): Events interrupted usual activities of daily living, or significantly affected clinical status, or required intensive therapeutic intervention. Severe events were usually incapacitating.

Outcome measures

Measure	AV-1 30 mg n=3 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 30 mg (volume: 250 mL) on Day 1.	AV-1 90 mg n=3 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 90 mg (volume: 250 mL) on Day 1.	AV-1 250 mg Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 250 mg (volume: 250 mL) on Day 1.	AV-1 500 mg n=1 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 500 mg (volume: 250 mL) on Day 1.	AV-1 1000 mg n=4 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 1000 mg (volume: 250 mL) on Day 1.	Placebo n=3 Participants Participants received a single IV infusion (infusion duration: 1 hour) of placebo (volume: 250 mL) on Day 1.
Number of Participants by Severity of AEs Mild	1 Participants	3 Participants	0 Participants	1 Participants	3 Participants	3 Participants
Number of Participants by Severity of AEs Moderate	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants by Severity of AEs Severe	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Predose (within 15 minutes); at 0.5, 1 (end of infusion), 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours after the start of infusion; Days 5, 8, 15, 22, 29, 43, 57, 85, and 120

Population: The pharmacokinetic (PK) population included participants who received the full dose of AV-1 and had at minimum all samples from predose through 1.5 hours from the start of infusion and had sufficient concentration data to support accurate estimation of at least 1 PK parameter. As placebo group did not receive AV-1, PK analysis for placebo group is not applicable.

AUC0-infinity was calculated as: AUC from time 0 to the last quantifiable concentration (AUC0-tlast) + (last observed serum drug concentration [Ct] / Apparent terminal elimination rate constant [λz]).

Outcome measures

Measure	AV-1 30 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 30 mg (volume: 250 mL) on Day 1.	AV-1 90 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 90 mg (volume: 250 mL) on Day 1.	AV-1 250 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 250 mg (volume: 250 mL) on Day 1.	AV-1 500 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 500 mg (volume: 250 mL) on Day 1.	AV-1 1000 mg n=7 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 1000 mg (volume: 250 mL) on Day 1.	Placebo Participants received a single IV infusion (infusion duration: 1 hour) of placebo (volume: 250 mL) on Day 1.
Area Under the Serum Concentration-time Curve (AUC) From Time 0 Extrapolated to Infinity (AUC0-infinity) of AV-1	7940 μg*hour/mL Geometric Coefficient of Variation 14.9	16700 μg*hour/mL Geometric Coefficient of Variation 29.7	52800 μg*hour/mL Geometric Coefficient of Variation 33.7	136000 μg*hour/mL Geometric Coefficient of Variation 48.1	250000 μg*hour/mL Geometric Coefficient of Variation 15.8	—

SECONDARY outcome

Timeframe: Predose (within 15 minutes); at 0.5, 1 (end of infusion), 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours after the start of infusion

Population: Participants in the PK Population who have were analyzed. As placebo group did not receive AV-1, PK analysis for placebo group is not applicable.

AUC0-48 was calculated using the linear trapezoidal rule method.

Outcome measures

Measure	AV-1 30 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 30 mg (volume: 250 mL) on Day 1.	AV-1 90 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 90 mg (volume: 250 mL) on Day 1.	AV-1 250 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 250 mg (volume: 250 mL) on Day 1.	AV-1 500 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 500 mg (volume: 250 mL) on Day 1.	AV-1 1000 mg n=7 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 1000 mg (volume: 250 mL) on Day 1.	Placebo Participants received a single IV infusion (infusion duration: 1 hour) of placebo (volume: 250 mL) on Day 1.
AUC From Time 0 to 48 Hours Postdose (AUC0-48) of AV-1	443 μg*hour/mL Geometric Coefficient of Variation 16.1	1340 μg*hour/mL Geometric Coefficient of Variation 19.7	3380 μg*hour/mL Geometric Coefficient of Variation 20.7	11400 μg*hour/mL Geometric Coefficient of Variation 74.1	16000 μg*hour/mL Geometric Coefficient of Variation 20.2	—

SECONDARY outcome

Timeframe: Predose (within 15 minutes); at 0.5, 1 (end of infusion), 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours after the start of infusion; Days 5, 8, 15, 22, 29, 43, 57, 85, and 120

Population: Participants in the PK Population who have were analyzed. As placebo group did not receive AV-1, PK analysis for placebo group is not applicable.

AUC0-tlast was calculated using the linear trapezoidal method.

Outcome measures

Measure	AV-1 30 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 30 mg (volume: 250 mL) on Day 1.	AV-1 90 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 90 mg (volume: 250 mL) on Day 1.	AV-1 250 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 250 mg (volume: 250 mL) on Day 1.	AV-1 500 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 500 mg (volume: 250 mL) on Day 1.	AV-1 1000 mg n=7 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 1000 mg (volume: 250 mL) on Day 1.	Placebo Participants received a single IV infusion (infusion duration: 1 hour) of placebo (volume: 250 mL) on Day 1.
AUC From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast)	7140 μg*hour/mL Geometric Coefficient of Variation 12.4	15900 μg*hour/mL Geometric Coefficient of Variation 27.9	48300 μg*hour/mL Geometric Coefficient of Variation 30.6	129000 μg*hour/mL Geometric Coefficient of Variation 48.0	233000 μg*hour/mL Geometric Coefficient of Variation 16.7	—

SECONDARY outcome

Timeframe: Predose (within 15 minutes); at 0.5, 1 (end of infusion), 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours after the start of infusion; Days 5, 8, 15, 22, 29, 43, 57, 85, and 120

Population: Participants in the PK Population who have were analyzed. As placebo group did not receive AV-1, PK analysis for placebo group is not applicable.

Cmax is defined as maximum observed serum drug concentration.

Outcome measures

Measure	AV-1 30 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 30 mg (volume: 250 mL) on Day 1.	AV-1 90 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 90 mg (volume: 250 mL) on Day 1.	AV-1 250 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 250 mg (volume: 250 mL) on Day 1.	AV-1 500 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 500 mg (volume: 250 mL) on Day 1.	AV-1 1000 mg n=7 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 1000 mg (volume: 250 mL) on Day 1.	Placebo Participants received a single IV infusion (infusion duration: 1 hour) of placebo (volume: 250 mL) on Day 1.
Maximum Observed Serum Concentration (Cmax) of AV-1	12.7 μg/mL Geometric Coefficient of Variation 10.8	41.8 μg/mL Geometric Coefficient of Variation 13.6	98.0 μg/mL Geometric Coefficient of Variation 22.0	332 μg/mL Geometric Coefficient of Variation 72.0	654 μg/mL Geometric Coefficient of Variation 87.2	—

SECONDARY outcome

Timeframe: Predose (within 15 minutes); at 0.5, 1 (end of infusion), 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours after the start of infusion; Days 5, 8, 15, 22, 29, 43, 57, 85, and 120

Population: Participants in the PK Population who have were analyzed. As placebo group did not receive AV-1, PK analysis for placebo group is not applicable.

Tmax is defined as Time to reach maximum serum concentration following drug administration.

Outcome measures

Measure	AV-1 30 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 30 mg (volume: 250 mL) on Day 1.	AV-1 90 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 90 mg (volume: 250 mL) on Day 1.	AV-1 250 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 250 mg (volume: 250 mL) on Day 1.	AV-1 500 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 500 mg (volume: 250 mL) on Day 1.	AV-1 1000 mg n=7 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 1000 mg (volume: 250 mL) on Day 1.	Placebo Participants received a single IV infusion (infusion duration: 1 hour) of placebo (volume: 250 mL) on Day 1.
Time to Reach Cmax (Tmax) of AV-1	2.00 hours Interval 1.57 to 12.0	4.00 hours Interval 1.0 to 8.0	1.38 hours Interval 1.0 to 3.0	2.49 hours Interval 1.0 to 4.0	2.00 hours Interval 1.0 to 6.05	—

SECONDARY outcome

Timeframe: Predose (within 15 minutes); at 0.5, 1 (end of infusion), 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours after the start of infusion; Days 5, 8, 15, 22, 29, 43, 57, 85, and 120

Population: Participants in the PK Population who have were analyzed. As placebo group did not receive AV-1, PK analysis for placebo group is not applicable.

t1/2 is defined as terminal half-life, calculated as: ln(2)/ λz, where λz is apparent terminal elimination rate constant.

Outcome measures

Measure	AV-1 30 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 30 mg (volume: 250 mL) on Day 1.	AV-1 90 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 90 mg (volume: 250 mL) on Day 1.	AV-1 250 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 250 mg (volume: 250 mL) on Day 1.	AV-1 500 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 500 mg (volume: 250 mL) on Day 1.	AV-1 1000 mg n=7 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 1000 mg (volume: 250 mL) on Day 1.	Placebo Participants received a single IV infusion (infusion duration: 1 hour) of placebo (volume: 250 mL) on Day 1.
Apparent Terminal Half-life (t1/2) of AV-1	910 hours Geometric Coefficient of Variation 15.8	631 hours Geometric Coefficient of Variation 25.0	768 hours Geometric Coefficient of Variation 33.8	700 hours Geometric Coefficient of Variation 24.4	732 hours Geometric Coefficient of Variation 19.5	—

SECONDARY outcome

Timeframe: Predose (within 15 minutes); at 0.5, 1 (end of infusion), 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours after the start of infusion; Days 5, 8, 15, 22, 29, 43, 57, 85, and 120

Population: Participants in the PK Population who have were analyzed. As placebo group did not receive AV-1, PK analysis for placebo group is not applicable.

Total serum clearance was calculated as dose divided by AUC0-infinity.

Outcome measures

Measure	AV-1 30 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 30 mg (volume: 250 mL) on Day 1.	AV-1 90 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 90 mg (volume: 250 mL) on Day 1.	AV-1 250 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 250 mg (volume: 250 mL) on Day 1.	AV-1 500 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 500 mg (volume: 250 mL) on Day 1.	AV-1 1000 mg n=7 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 1000 mg (volume: 250 mL) on Day 1.	Placebo Participants received a single IV infusion (infusion duration: 1 hour) of placebo (volume: 250 mL) on Day 1.
Total Serum Clearance (CL) of AV-1	0.00378 Liter/hour Geometric Coefficient of Variation 14.9	0.00539 Liter/hour Geometric Coefficient of Variation 29.7	0.00474 Liter/hour Geometric Coefficient of Variation 33.7	0.00366 Liter/hour Geometric Coefficient of Variation 48.1	0.00399 Liter/hour Geometric Coefficient of Variation 15.8	—

SECONDARY outcome

Timeframe: Predose (within 15 minutes); at 0.5, 1 (end of infusion), 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours after the start of infusion; Days 5, 8, 15, 22, 29, 43, 57, 85, and 120

Population: Participants in the PK Population who have were analyzed. As placebo group did not receive AV-1, PK analysis for placebo group is not applicable.

Volume of distribution during the terminal phase was calculated as dose divided by (AUC0-infinity*λz).

Outcome measures

Measure	AV-1 30 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 30 mg (volume: 250 mL) on Day 1.	AV-1 90 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 90 mg (volume: 250 mL) on Day 1.	AV-1 250 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 250 mg (volume: 250 mL) on Day 1.	AV-1 500 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 500 mg (volume: 250 mL) on Day 1.	AV-1 1000 mg n=7 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 1000 mg (volume: 250 mL) on Day 1.	Placebo Participants received a single IV infusion (infusion duration: 1 hour) of placebo (volume: 250 mL) on Day 1.
Volume of Distribution During the Terminal Phase (Vz) of AV-1	4.96 Liter Geometric Coefficient of Variation 9.0	4.90 Liter Geometric Coefficient of Variation 21.7	5.25 Liter Geometric Coefficient of Variation 24.0	3.70 Liter Geometric Coefficient of Variation 53.6	4.22 Liter Geometric Coefficient of Variation 25.0	—

SECONDARY outcome

Timeframe: Baseline, Days 29 (±2), 85 (±5), and 120 (±5)

Population: Participants in the Safety Population were analyzed.

Serum samples for measurement of anti-AV-1 antibody levels were analyzed by a validated electrochemiluminescence enzyme-linked immunosorbent assay method used for detection and confirmation of pre-existing and treatment-emergent anti-AV-1 antibodies in serum samples based on the MesoScale Discovery platform that utilized labeled AV-1 for detection of anti-AV-1 antibodies and treatment-emergent antibodies. Number of participants with detectable anti-AV-1 antibody

Outcome measures

Measure	AV-1 30 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 30 mg (volume: 250 mL) on Day 1.	AV-1 90 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 90 mg (volume: 250 mL) on Day 1.	AV-1 250 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 250 mg (volume: 250 mL) on Day 1.	AV-1 500 mg n=6 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 500 mg (volume: 250 mL) on Day 1.	AV-1 1000 mg n=7 Participants Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 1000 mg (volume: 250 mL) on Day 1.	Placebo n=11 Participants Participants received a single IV infusion (infusion duration: 1 hour) of placebo (volume: 250 mL) on Day 1.
Number of Participants With Detectable Anti-AV-1 Antibody Day 120 (±5)	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Detectable Anti-AV-1 Antibody Baseline	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Detectable Anti-AV-1 Antibody Day 29 (±2)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Detectable Anti-AV-1 Antibody Day 85 (±5)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

AV-1 30 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

AV-1 90 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

AV-1 250 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

AV-1 500 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

AV-1 1000 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	AV-1 30 mg n=6 participants at risk Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 30 mg (volume: 250 mL) on Day 1.	AV-1 90 mg n=6 participants at risk Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 90 mg (volume: 250 mL) on Day 1.	AV-1 250 mg n=6 participants at risk Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 250 mg (volume: 250 mL) on Day 1.	AV-1 500 mg n=6 participants at risk Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 500 mg (volume: 250 mL) on Day 1.	AV-1 1000 mg n=7 participants at risk Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 1000 mg (volume: 250 mL) on Day 1.	Placebo n=11 participants at risk Participants received a single IV infusion (infusion duration: 1 hour) of placebo (volume: 250 mL) on Day 1.
General disorders Pyrexia	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	14.3% 1/7 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	9.1% 1/11 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.
General disorders Feeling hot	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/7 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	9.1% 1/11 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.
General disorders Feeling of body temperature change	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	14.3% 1/7 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/11 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.
General disorders Infusion site discomfort	16.7% 1/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/7 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/11 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.
Infections and infestations Bronchitis	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	16.7% 1/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/7 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/11 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.
Infections and infestations COVID-19	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	14.3% 1/7 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/11 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.
Infections and infestations Upper respiratory tract infection	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/7 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	9.1% 1/11 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.
Investigations Electrocardiogram QT prolonged	33.3% 2/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	14.3% 1/7 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/11 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.
Investigations Blood glucose increased	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	14.3% 1/7 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/11 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.
Gastrointestinal disorders Toothache	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	33.3% 2/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/7 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/11 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.
Nervous system disorders Headache	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	16.7% 1/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	14.3% 1/7 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/11 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.
Cardiac disorders Atrioventricular block first degree	16.7% 1/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/7 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/11 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.
Immune system disorders Seasonal allergy	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/7 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	9.1% 1/11 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.
Reproductive system and breast disorders Intermenstrual bleeding	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	14.3% 1/7 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/11 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	14.3% 1/7 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/11 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/6 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	14.3% 1/7 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.	0.00% 0/11 • Baseline up to Day 120 (± 5 days) The Safety population included all participants who received any amount of the investigational product.

Additional Information

Urban Ramstedt

AbViro LLC

Phone: 617-818-8112

Email: urban.ramstedt@abviro.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place