Trial Outcomes & Findings for A Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of VIS954 in Healthy Adult Participants (NCT NCT06212804)

Results Overview

An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) was any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via an authorized medicinal product or was an important medical event that jeopardized the participant or required medical or surgical intervention to prevent 1 of the other outcomes listed above. TEAEs were AEs that first occurred or worsened in severity after the study intervention administration, and up to Day 71 (including the follow-up period) after the study intervention administration.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

54 participants

Primary outcome timeframe

From study intervention administration (Day 1) up to end of follow-up (Day 71)

Results posted on

2025-07-14

Participant Flow

This Phase 1, double-blind, single ascending dose, first-in-human study was conducted in healthy participants at a single investigational site.

The study was conducted in 6 sequential cohorts. In each cohort, participants were randomized in a 7:2 ratio to receive VIS954 or matching placebo. The study consisted of a screening period (up to 28 days before dosing), dosing on Day 1, a post-dose period (Days 5 to 57) and a final follow-up visit on Day 71. A total of 54 participants were enrolled in the study.

Participant milestones

Participant milestones
Measure	Cohort 1: VIS954 Dose 1 Participants received a single dose of VIS954 at Dose 1 via subcutaneous (SC) injection on Day 1.	Cohort 2: VIS954 Dose 2 Participants received a single dose of VIS954 at Dose 2 via SC injection on Day 1.	Cohort 3: VIS954 Dose 3 Participants received a single dose of VIS954 at Dose 3 via SC injection on Day 1.	Cohort 4: VIS954 Dose 4 Participants received a single dose of VIS954 at Dose 4 via SC injection on Day 1.	Cohort 5: VIS954 Dose 5 Participants received a single dose of VIS954 at Dose 5 via SC injection on Day 1.	Cohort 6: VIS954 Dose 6 Participants received a single dose of VIS954 at Dose 6 via SC injection on Day 1.	Cohort 1 to 6: Pooled Placebo Participants received a single dose of placebo matched to VIS954 via SC injection on Day 1.
Overall Study STARTED	7	7	7	7	7	7	12
Overall Study COMPLETED	7	7	7	7	7	7	12
Overall Study NOT COMPLETED	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of VIS954 in Healthy Adult Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: VIS954 Dose 1 n=7 Participants Participants received a single dose of VIS954 at Dose 1 via SC injection on Day 1.	Cohort 2: VIS954 Dose 2 n=7 Participants Participants received a single dose of VIS954 at Dose 2 via SC injection on Day 1.	Cohort 3: VIS954 Dose 3 n=7 Participants Participants received a single dose of VIS954 at Dose 3 via SC injection on Day 1.	Cohort 4: VIS954 Dose 4 n=7 Participants Participants received a single dose of VIS954 at Dose 4 via SC injection on Day 1.	Cohort 5: VIS954 Dose 5 n=7 Participants Participants received a single dose of VIS954 at Dose 5 via SC injection on Day 1.	Cohort 6: VIS954 Dose 6 n=7 Participants Participants received a single dose of VIS954 at Dose 6 via SC injection on Day 1.	Cohort 1 to 6: Pooled Placebo n=12 Participants Participants received a single dose of placebo matched to VIS954 via SC injection on Day 1.	Total n=54 Participants Total of all reporting groups
Age, Continuous	35.4 years STANDARD_DEVIATION 8.2 • n=5 Participants	40.6 years STANDARD_DEVIATION 8.1 • n=7 Participants	38.9 years STANDARD_DEVIATION 9.6 • n=5 Participants	39.0 years STANDARD_DEVIATION 7.7 • n=4 Participants	39.4 years STANDARD_DEVIATION 9.3 • n=21 Participants	39.0 years STANDARD_DEVIATION 10.2 • n=8 Participants	36.5 years STANDARD_DEVIATION 7.6 • n=8 Participants	38.2 years STANDARD_DEVIATION 8.3 • n=24 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	2 Participants n=21 Participants	3 Participants n=8 Participants	7 Participants n=8 Participants	29 Participants n=24 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	5 Participants n=21 Participants	4 Participants n=8 Participants	5 Participants n=8 Participants	25 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants	3 Participants n=8 Participants	10 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	5 Participants n=4 Participants	6 Participants n=21 Participants	5 Participants n=8 Participants	9 Participants n=8 Participants	44 Participants n=24 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	0 Participants n=24 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	4 Participants n=8 Participants	11 Participants n=24 Participants
Race/Ethnicity, Customized Asian	4 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	6 Participants n=21 Participants	3 Participants n=8 Participants	1 Participants n=8 Participants	23 Participants n=24 Participants
Race/Ethnicity, Customized White	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=8 Participants	5 Participants n=8 Participants	14 Participants n=24 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	2 Participants n=24 Participants
Race/Ethnicity, Customized Multiple	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants	4 Participants n=24 Participants

PRIMARY outcome

Timeframe: From study intervention administration (Day 1) up to end of follow-up (Day 71)

Population: The safety analysis set included all participants who received trial intervention (active or placebo).

An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) was any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via an authorized medicinal product or was an important medical event that jeopardized the participant or required medical or surgical intervention to prevent 1 of the other outcomes listed above. TEAEs were AEs that first occurred or worsened in severity after the study intervention administration, and up to Day 71 (including the follow-up period) after the study intervention administration.

Outcome measures

Outcome measures
Measure	Cohort 1: VIS954 Dose 1 n=7 Participants Participants received a single dose of VIS954 at Dose 1 via SC injection on Day 1.	Cohort 2: VIS954 Dose 2 n=7 Participants Participants received a single dose of VIS954 at Dose 2 via SC injection on Day 1.	Cohort 3: VIS954 Dose 3 n=7 Participants Participants received a single dose of VIS954 at Dose 3 via SC injection on Day 1.	Cohort 4: VIS954 Dose 4 n=7 Participants Participants received a single dose of VIS954 at Dose 4 via SC injection on Day 1.	Cohort 5: VIS954 Dose 5 n=7 Participants Participants received a single dose of VIS954 at Dose 5 via SC injection on Day 1.	Cohort 6: VIS954 Dose 6 n=7 Participants Participants received a single dose of VIS954 at Dose 6 via SC injection on Day 1.	Cohort 1 to 6: Pooled Placebo n=12 Participants Participants received a single dose of placebo matched to VIS954 via SC injection on Day 1.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) TEAEs	2 Participants	1 Participants	1 Participants	1 Participants	3 Participants	2 Participants	4 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) TESAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 1 (1 and 4 hours post-dose), Day 2 (24 hours post-dose), and on Days 3 and 29

Population: The safety analysis set included all participants who received trial intervention (active or placebo).

The Wong-Baker FACES Pain Rating Scale was a subjective self-report that was used to record each participant's perception of pain associated with their injection. The scale ranged from 0 to 10 and showed a series of faces ranging from a happy face at 0 which represented "no hurt" to a crying face at 10 which represented "hurts worst." Based on the faces and descriptions, the participant recorded their level of pain. Higher scores indicated more severe pain.

Outcome measures

Outcome measures
Measure	Cohort 1: VIS954 Dose 1 n=7 Participants Participants received a single dose of VIS954 at Dose 1 via SC injection on Day 1.	Cohort 2: VIS954 Dose 2 n=7 Participants Participants received a single dose of VIS954 at Dose 2 via SC injection on Day 1.	Cohort 3: VIS954 Dose 3 n=7 Participants Participants received a single dose of VIS954 at Dose 3 via SC injection on Day 1.	Cohort 4: VIS954 Dose 4 n=7 Participants Participants received a single dose of VIS954 at Dose 4 via SC injection on Day 1.	Cohort 5: VIS954 Dose 5 n=7 Participants Participants received a single dose of VIS954 at Dose 5 via SC injection on Day 1.	Cohort 6: VIS954 Dose 6 n=7 Participants Participants received a single dose of VIS954 at Dose 6 via SC injection on Day 1.	Cohort 1 to 6: Pooled Placebo n=12 Participants Participants received a single dose of placebo matched to VIS954 via SC injection on Day 1.
Wong-Baker FACES Pain Rating Scale Day 1: 1 hour post-dose	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0	0.3 units on a scale Standard Deviation 0.8	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0	0.3 units on a scale Standard Deviation 1.2
Wong-Baker FACES Pain Rating Scale Day 1: 4 hours post-dose	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0	0.3 units on a scale Standard Deviation 1.2
Wong-Baker FACES Pain Rating Scale Day 2: 24 hours post-dose	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0
Wong-Baker FACES Pain Rating Scale Day 3	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0
Wong-Baker FACES Pain Rating Scale Day 29	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: Day 1 (within 2 hours pre-dose) and at multiple timepoints post-dose up to Day 71

Population: PK analysis set: participants who received VIS954 and had at least 1 measured post-dose VIS954 serum concentration at scheduled PK time after start of dosing for at least 1 PK analyte without protocol deviations/events with potential to affect evaluation of PK data. As pre-specified in SAP, 13 participants (7 and 6 in Cohorts 1 and 2) were excluded from PK analysis as PK profiles were below limit of quantitation (BLQ). Only participants with data collected at specified timepoints are reported.

Blood samples were collected for measurement of serum concentrations of VIS954 at the specified time points from Day 1 (within 2 hours pre-dose) to Day 71. The pharmacokinetic (PK) parameters of VIS954 were derived using noncompartmental analysis method.

Outcome measures

Outcome measures
Measure	Cohort 1: VIS954 Dose 1 Participants received a single dose of VIS954 at Dose 1 via SC injection on Day 1.	Cohort 2: VIS954 Dose 2 n=1 Participants Participants received a single dose of VIS954 at Dose 2 via SC injection on Day 1.	Cohort 3: VIS954 Dose 3 n=7 Participants Participants received a single dose of VIS954 at Dose 3 via SC injection on Day 1.	Cohort 4: VIS954 Dose 4 n=6 Participants Participants received a single dose of VIS954 at Dose 4 via SC injection on Day 1.	Cohort 5: VIS954 Dose 5 n=7 Participants Participants received a single dose of VIS954 at Dose 5 via SC injection on Day 1.	Cohort 6: VIS954 Dose 6 n=7 Participants Participants received a single dose of VIS954 at Dose 6 via SC injection on Day 1.	Cohort 1 to 6: Pooled Placebo Participants received a single dose of placebo matched to VIS954 via SC injection on Day 1.
Maximum Serum Concentration (Cmax) of VIS954	—	0.0660 micrograms per milliliter (mcg/mL) Standard Deviation NA NA indicates that the standard deviation (SD) was not estimable for 1 participant.	1.961 micrograms per milliliter (mcg/mL) Standard Deviation 1.378	4.423 micrograms per milliliter (mcg/mL) Standard Deviation 2.851	16.82 micrograms per milliliter (mcg/mL) Standard Deviation 12.95	32.61 micrograms per milliliter (mcg/mL) Standard Deviation 12.00	—

SECONDARY outcome

Timeframe: Day 1 (within 2 hours pre-dose) and at multiple timepoints post-dose up to Day 71

Population: The PK analysis set included all participants who received VIS954 and had at least 1 measured post-dose VIS954 serum concentration at scheduled PK time after start of dosing for at least 1 PK analyte without protocol deviations or events with potential to affect the evaluation of the PK data. As pre-specified in SAP, 13 participants (7 and 6 in Cohorts 1 and 2) were excluded from PK analysis as PK profiles were BLQ. Only participants with data collected at specified timepoints are reported.

Blood samples were collected for measurement of serum concentrations of VIS954 at the specified time points from Day 1 (within 2 hours pre-dose) to Day 71. The PK parameters of VIS954 were derived using noncompartmental analysis method.

Outcome measures

Outcome measures
Measure	Cohort 1: VIS954 Dose 1 Participants received a single dose of VIS954 at Dose 1 via SC injection on Day 1.	Cohort 2: VIS954 Dose 2 n=1 Participants Participants received a single dose of VIS954 at Dose 2 via SC injection on Day 1.	Cohort 3: VIS954 Dose 3 n=7 Participants Participants received a single dose of VIS954 at Dose 3 via SC injection on Day 1.	Cohort 4: VIS954 Dose 4 n=6 Participants Participants received a single dose of VIS954 at Dose 4 via SC injection on Day 1.	Cohort 5: VIS954 Dose 5 n=7 Participants Participants received a single dose of VIS954 at Dose 5 via SC injection on Day 1.	Cohort 6: VIS954 Dose 6 n=7 Participants Participants received a single dose of VIS954 at Dose 6 via SC injection on Day 1.	Cohort 1 to 6: Pooled Placebo Participants received a single dose of placebo matched to VIS954 via SC injection on Day 1.
Time of Maximum Serum Concentration (Tmax) of VIS954	—	48.00 hour Interval 48.0 to 48.0	48.00 hour Interval 4.02 to 98.35	71.82 hour Interval 48.0 to 166.38	74.02 hour Interval 72.12 to 169.7	95.60 hour Interval 48.0 to 169.7	—

SECONDARY outcome

Timeframe: Day 1 (within 2 hours pre-dose) and at multiple timepoints post-dose up to Day 71

Population: The PK analysis set included all participants who received VIS954 and had at least 1 measured post-dose VIS954 serum concentration at scheduled PK time after start of dosing for at least 1 PK analyte without protocol deviations or events with potential to affect the evaluation of the PK data. As pre-specified in SAP, 13 participants (7 and 6 in Cohorts 1 and 2) were excluded from PK analysis as PK profiles were BLQ. Only participants with data collected at specified timepoints are reported.

Blood samples were collected for measurement of serum concentrations of VIS954 at the specified time points from Day 1 (within 2 hours pre-dose) to Day 71. The PK parameters of VIS954 were derived using noncompartmental analysis method.

Outcome measures

Outcome measures
Measure	Cohort 1: VIS954 Dose 1 Participants received a single dose of VIS954 at Dose 1 via SC injection on Day 1.	Cohort 2: VIS954 Dose 2 Participants received a single dose of VIS954 at Dose 2 via SC injection on Day 1.	Cohort 3: VIS954 Dose 3 n=1 Participants Participants received a single dose of VIS954 at Dose 3 via SC injection on Day 1.	Cohort 4: VIS954 Dose 4 n=3 Participants Participants received a single dose of VIS954 at Dose 4 via SC injection on Day 1.	Cohort 5: VIS954 Dose 5 n=4 Participants Participants received a single dose of VIS954 at Dose 5 via SC injection on Day 1.	Cohort 6: VIS954 Dose 6 n=7 Participants Participants received a single dose of VIS954 at Dose 6 via SC injection on Day 1.	Cohort 1 to 6: Pooled Placebo Participants received a single dose of placebo matched to VIS954 via SC injection on Day 1.
Area Under the Concentration-Time Curve From Pre-dose Extrapolated to Infinite Time (AUC0-inf) of VIS954	—	—	395 hour*mcg/mL Standard Deviation NA NA indicates that the SD was not estimable for 1 participant.	1463 hour*mcg/mL Standard Deviation 1324	5529 hour*mcg/mL Standard Deviation 1877	11560 hour*mcg/mL Standard Deviation 5503	—

SECONDARY outcome

Timeframe: Day 1 (within 2 hours pre-dose) and at multiple timepoints post-dose up to Day 71

Population: The PK analysis set included all participants who received VIS954 and had at least 1 measured post-dose VIS954 serum concentration at scheduled PK time after start of dosing for at least 1 PK analyte without protocol deviations or events with potential to affect the evaluation of the PK data. As pre-specified in SAP, 13 participants (7 and 6 in Cohorts 1 and 2) were excluded from PK analysis as PK profiles were BLQ. Only participants with data collected at specified timepoints are reported.

Blood samples were collected for measurement of serum concentrations of VIS954 at the specified time points from Day 1 (within 2 hours pre-dose) to Day 71. The PK parameters of VIS954 were derived using noncompartmental analysis method.

Outcome measures

Outcome measures
Measure	Cohort 1: VIS954 Dose 1 Participants received a single dose of VIS954 at Dose 1 via SC injection on Day 1.	Cohort 2: VIS954 Dose 2 n=1 Participants Participants received a single dose of VIS954 at Dose 2 via SC injection on Day 1.	Cohort 3: VIS954 Dose 3 n=7 Participants Participants received a single dose of VIS954 at Dose 3 via SC injection on Day 1.	Cohort 4: VIS954 Dose 4 n=6 Participants Participants received a single dose of VIS954 at Dose 4 via SC injection on Day 1.	Cohort 5: VIS954 Dose 5 n=7 Participants Participants received a single dose of VIS954 at Dose 5 via SC injection on Day 1.	Cohort 6: VIS954 Dose 6 n=7 Participants Participants received a single dose of VIS954 at Dose 6 via SC injection on Day 1.	Cohort 1 to 6: Pooled Placebo Participants received a single dose of placebo matched to VIS954 via SC injection on Day 1.
Area Under the Concentration-Time Curve From Pre-dose to the Last Quantifiable Concentration (AUC0-last) of VIS954	—	3.17 hour*mcg/mL Standard Deviation NA NA indicates that the SD was not estimable for 1 participant.	188.4 hour*mcg/mL Standard Deviation 151.2	872.4 hour*mcg/mL Standard Deviation 974.1	3604 hour*mcg/mL Standard Deviation 2684	11470 hour*mcg/mL Standard Deviation 5458	—

SECONDARY outcome

Timeframe: Day 1 (within 2 hours pre-dose) and at multiple timepoints post-dose up to Day 71

Population: The PK analysis set included all participants who received VIS954 and had at least 1 measured post-dose VIS954 serum concentration at scheduled PK time after start of dosing for at least 1 PK analyte without protocol deviations or events with potential to affect the evaluation of the PK data. As pre-specified in SAP, 13 participants (7 and 6 in Cohorts 1 and 2) were excluded from PK analysis as PK profiles were BLQ. Only participants with data collected at specified timepoints are reported.

Blood samples were collected for measurement of serum concentrations of VIS954 at the specified time points from Day 1 (within 2 hours pre-dose) to Day 71. The PK parameters of VIS954 were derived using noncompartmental analysis method.

Outcome measures

Outcome measures
Measure	Cohort 1: VIS954 Dose 1 Participants received a single dose of VIS954 at Dose 1 via SC injection on Day 1.	Cohort 2: VIS954 Dose 2 Participants received a single dose of VIS954 at Dose 2 via SC injection on Day 1.	Cohort 3: VIS954 Dose 3 n=2 Participants Participants received a single dose of VIS954 at Dose 3 via SC injection on Day 1.	Cohort 4: VIS954 Dose 4 n=3 Participants Participants received a single dose of VIS954 at Dose 4 via SC injection on Day 1.	Cohort 5: VIS954 Dose 5 n=4 Participants Participants received a single dose of VIS954 at Dose 5 via SC injection on Day 1.	Cohort 6: VIS954 Dose 6 n=7 Participants Participants received a single dose of VIS954 at Dose 6 via SC injection on Day 1.	Cohort 1 to 6: Pooled Placebo Participants received a single dose of placebo matched to VIS954 via SC injection on Day 1.
Apparent Terminal Elimination Half-Life (t1/2) of VIS954	—	—	85.25 hour Interval 37.5 to 133.0	33.6 hour Interval 25.8 to 105.0	48.0 hour Interval 41.3 to 82.4	76.3 hour Interval 44.7 to 101.0	—

SECONDARY outcome

Timeframe: Day 1 (within 2 hours pre-dose) and at multiple timepoints post-dose up to Day 71

Population: The PK analysis set included all participants who received VIS954 and had at least 1 measured post-dose VIS954 serum concentration at scheduled PK time after start of dosing for at least 1 PK analyte without protocol deviations or events with potential to affect the evaluation of the PK data. As pre-specified in SAP, 13 participants (7 and 6 in Cohorts 1 and 2) were excluded from PK analysis as PK profiles were BLQ. Only participants with data collected at specified timepoints are reported.

Blood samples were collected for measurement of serum concentrations of VIS954 at the specified time points from Day 1 (within 2 hours pre-dose) to Day 71. The PK parameters of VIS954 were derived using noncompartmental analysis method.

Outcome measures

Outcome measures
Measure	Cohort 1: VIS954 Dose 1 Participants received a single dose of VIS954 at Dose 1 via SC injection on Day 1.	Cohort 2: VIS954 Dose 2 Participants received a single dose of VIS954 at Dose 2 via SC injection on Day 1.	Cohort 3: VIS954 Dose 3 n=1 Participants Participants received a single dose of VIS954 at Dose 3 via SC injection on Day 1.	Cohort 4: VIS954 Dose 4 n=3 Participants Participants received a single dose of VIS954 at Dose 4 via SC injection on Day 1.	Cohort 5: VIS954 Dose 5 n=4 Participants Participants received a single dose of VIS954 at Dose 5 via SC injection on Day 1.	Cohort 6: VIS954 Dose 6 n=7 Participants Participants received a single dose of VIS954 at Dose 6 via SC injection on Day 1.	Cohort 1 to 6: Pooled Placebo Participants received a single dose of placebo matched to VIS954 via SC injection on Day 1.
Apparent Volume of Distribution (Vd/F) of VIS954	—	—	12.3 liter Standard Deviation NA NA indicates that the SD was not estimable for 1 participant.	10.12 liter Standard Deviation 1.797	5.218 liter Standard Deviation 1.606	8.536 liter Standard Deviation 5.579	—

SECONDARY outcome

Timeframe: Day 1 (within 2 hours pre-dose) and at multiple timepoints post-dose up to Day 71

Population: The PK analysis set included all participants who received VIS954 and had at least 1 measured post-dose VIS954 serum concentration at scheduled PK time after start of dosing for at least 1 PK analyte without protocol deviations or events with potential to affect the evaluation of the PK data. As pre-specified in SAP, 13 participants (7 and 6 in Cohorts 1 and 2) were excluded from PK analysis as PK profiles were BLQ. Only participants with data collected at specified timepoints are reported.

Blood samples were collected for measurement of serum concentrations of VIS954 at the specified time points from Day 1 (within 2 hours pre-dose) to Day 71. The PK parameters of VIS954 were derived using noncompartmental analysis method.

Outcome measures

Outcome measures
Measure	Cohort 1: VIS954 Dose 1 Participants received a single dose of VIS954 at Dose 1 via SC injection on Day 1.	Cohort 2: VIS954 Dose 2 Participants received a single dose of VIS954 at Dose 2 via SC injection on Day 1.	Cohort 3: VIS954 Dose 3 n=1 Participants Participants received a single dose of VIS954 at Dose 3 via SC injection on Day 1.	Cohort 4: VIS954 Dose 4 n=3 Participants Participants received a single dose of VIS954 at Dose 4 via SC injection on Day 1.	Cohort 5: VIS954 Dose 5 n=4 Participants Participants received a single dose of VIS954 at Dose 5 via SC injection on Day 1.	Cohort 6: VIS954 Dose 6 n=7 Participants Participants received a single dose of VIS954 at Dose 6 via SC injection on Day 1.	Cohort 1 to 6: Pooled Placebo Participants received a single dose of placebo matched to VIS954 via SC injection on Day 1.
Apparent Clearance After Extravascular Dosing (CL/F) of VIS954	—	—	0.228 liter per hour Standard Deviation NA NA indicates that the SD was not estimable for 1 participant.	0.1864 liter per hour Standard Deviation 0.1108	0.06911 liter per hour Standard Deviation 0.02358	0.07976 liter per hour Standard Deviation 0.05542	—

SECONDARY outcome

Timeframe: Baseline (Day -1) up to Day 71

Population: The PD analysis set included all participants who received trial intervention (active or placebo) and had at least 1 measured PD value at a scheduled time point after start of dosing.

Blood samples were collected at the specified time points to characterize the effect of VIS954 binding. The time spent above 40% RO was defined as duration in hours from date and time of dosing until the date and time of pharmacodynamic (PD) collection when %RO \>40%. Baseline was defined as the last non-missing measurement taken prior to reference start date (including unscheduled assessments).