Huntington's Disease
Conditions
Brief summary
PRECISION-HD1 is a Phase 1b/2a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of WVE-120101 in adult patients with early manifest Huntington's disease (HD) who carry a targeted single nucleotide polymorphism (SNP) rs362307 (SNP1).
Interventions
DRUGWVE-120101
WVE-120101 is a stereopure antisense oligonucleotide (ASO)
DRUGPlacebo
0.9% Sodium Chloride
Sponsors
Wave Life Sciences Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Prescreened with targeted SNP on the same allele as the pathogenic CAG expansion * Ambulatory, male or female patients aged ≥25 - ≤65 years * Clinical diagnostic motor features of HD, defined as Unified Huntington's Disease Rating Scale (UHDRS) Diagnostic Confidence Score = 4 * Early manifest HD, Stage I or Stage II based on UHDRS Total Functional Capacity Scores ≥7 and ≤13 Key
Exclusion criteria
* Malignancy or received treatment for malignancy, other than treated basal cell or squamous cell carcinoma of the skin, within the previous 5 years. * Received investigational drug or implantable device in prior 3 months or investigational oligonucleotide in prior 6 months or 5 half-lives of the oligonucleotide, whichever is longer * Clinically significant medical condition, unstable psychiatric symptoms, substance abuse, or pregnancy * Inability to undergo brain MRI * Bone, spine, bleeding, or other disorder that exposes the patient to risk of injury or unsuccessful lumbar puncture
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Number of Patients With Treatment-emergent Adverse Events (TEAEs) | Day 1 to end of study (up to Day 182 [32 mg cohort]/ Day 210 [all other cohorts]) | All TEAEs reported or observed during the study, including TEAEs resulting from concurrent illnesses, reactions to concurrent medications, or progression of disease states |
| Safety: Severity of Adverse Events | Day 1 to end of study (up to Day 182 [32 mg cohort]/ Day 210 [all other cohorts]) | Number of patients who experienced a severe treatment-emergent adverse event. Severity was evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 |
| Safety: Number of Patients With Serious TEAEs | Day 1 to end of study (up to Day 182 [32 mg cohort]/ Day 210 [all other cohorts]) | A serious TEAE is defined as any event that results in death, is immediately life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect not present at Prescreening. |
| Safety and Tolerability: Number of Patients Who Withdraw Due to TEAEs | Day 1 to end of study (up to Day 182 [32 mg cohort]/ Day 210 [all other cohorts]) | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacodynamics | Day 1 to last observation - up to Day 140 (32 mg cohort) or Day 196 (all other cohorts) | Percentage change from baseline in concentration of mutant huntingtin (mHTT) protein in CSF |
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) | Patients participating in Period 1 (SAD) had PK samples collected on Day 1 predose through 24-48 hours postdose. Patients participating in Period 2 (MAD) had PK samples collected predose on Day 112 and through 4 hours postdose. | Cmax of WVE-120101 in plasma |
| Clinical Effects: Total Functional Capacity (TFC) | Day 1 to last observation - up to Day 140 (32 mg cohort) or Day 196 (all other cohorts) | Percentage change from baseline to the last measured time point in the Total Functional Capacity score, administered as part of the Unified Huntington's Disease Rating Scale (UHDRS). Total Functional Capacity is scored 13 (normal) to 0 (severe disability). |
| PK: Time of Occurrence of Cmax (Tmax) | Patients participating in Period 1 (SAD) had PK samples collected on Day 1 predose through 24-48 hours postdose. Patients participating in Period 2 (MAD) had PK samples collected predose on Day 112 and through 4 hours postdose. | tmax of WVE-120101 in plasma |
| PK: Area Under the Plasma Concentration-time Curve (AUClast) | Patients participating in Period 1 (SAD) had PK samples collected on Day 1 predose through 24-48 hours postdose. Patients participating in Period 2 (MAD) had PK samples collected predose on Day 112 and through 4 hours postdose. | AUClast from time 0 to the last quantifiable concentration of WVE-120101 in plasma |
| PK: Terminal Elimination Half Life | Patients participating in Period 1 (SAD) had PK samples collected on Day 1 predose through 24-48 hours postdose. Patients participating in Period 2 (MAD) had PK samples collected predose on Day 112 and through 4 hours postdose. | Terminal elimination half life of WVE-120101 in plasma (t1/2) |
Countries
Australia, Canada, Denmark, France, Germany, Poland, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pooled Placebo Placebo: 0.9% Sodium Chloride | 16 |
| WVE-120101 (2 mg) WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO) | 9 |
| WVE-120101 (4 mg) WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO) | 9 |
| WVE-120101 (8 mg) WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO) | 9 |
| WVE-120101 (16 mg) WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO) | 8 |
| WVE-120101 (32 mg) WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO) | 10 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 2 | 0 | 0 | 2 |
| Overall Study | Sponsor Decision | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Termination of Study by Sponsor | 4 | 0 | 0 | 0 | 0 | 7 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Pooled Placebo | WVE-120101 (2 mg) | WVE-120101 (4 mg) | WVE-120101 (8 mg) | WVE-120101 (16 mg) | WVE-120101 (32 mg) | Total |
|---|---|---|---|---|---|---|---|
| Age at Disease Onset | 40.75 Years STANDARD_DEVIATION 11.079 | 37.33 Years STANDARD_DEVIATION 7.826 | 42.89 Years STANDARD_DEVIATION 9.28 | 46.11 Years STANDARD_DEVIATION 6.254 | 44.88 Years STANDARD_DEVIATION 12.495 | 44.60 Years STANDARD_DEVIATION 10.865 | 43.16 Years STANDARD_DEVIATION 9.625 |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 9 Participants | 9 Participants | 9 Participants | 8 Participants | 10 Participants | 60 Participants |
| Diagnosis Stage Stage 1 | 9 Participants | 7 Participants | 3 Participants | 3 Participants | 4 Participants | 7 Participants | 33 Participants |
| Diagnosis Stage Stage 2 | 7 Participants | 2 Participants | 6 Participants | 6 Participants | 4 Participants | 3 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 9 Participants | 9 Participants | 9 Participants | 8 Participants | 10 Participants | 61 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 9 Participants | 9 Participants | 9 Participants | 8 Participants | 10 Participants | 61 Participants |
| Region of Enrollment Australia | 4 participants | 0 participants | 0 participants | 6 participants | 3 participants | 4 participants | 17 participants |
| Region of Enrollment Canada | 4 participants | 2 participants | 2 participants | 1 participants | 0 participants | 3 participants | 12 participants |
| Region of Enrollment Denmark | 0 participants | 0 participants | 0 participants | 1 participants | 1 participants | 0 participants | 2 participants |
| Region of Enrollment France | 1 participants | 0 participants | 0 participants | 0 participants | 1 participants | 2 participants | 4 participants |
| Region of Enrollment Germany | 2 participants | 0 participants | 0 participants | 0 participants | 1 participants | 1 participants | 4 participants |
| Region of Enrollment Poland | 4 participants | 7 participants | 5 participants | 1 participants | 2 participants | 0 participants | 19 participants |
| Region of Enrollment United Kingdom | 1 participants | 0 participants | 2 participants | 0 participants | 0 participants | 0 participants | 3 participants |
| Sex: Female, Male Female | 7 Participants | 3 Participants | 5 Participants | 6 Participants | 1 Participants | 7 Participants | 29 Participants |
| Sex: Female, Male Male | 9 Participants | 6 Participants | 4 Participants | 3 Participants | 7 Participants | 3 Participants | 32 Participants |
| Time since initial diagnosis | 7 Years STANDARD_DEVIATION 6.93 | 4.9 Years STANDARD_DEVIATION 4.28 | 3.4 Years STANDARD_DEVIATION 6.37 | 3.2 Years STANDARD_DEVIATION 3.03 | 6.6 Years STANDARD_DEVIATION 6.09 | 8.7 Years STANDARD_DEVIATION 7.26 | 5.4 Years STANDARD_DEVIATION 5.8 |
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 |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 8 | 0 / 10 |
| other Total, other adverse events | 12 / 16 | 8 / 9 | 8 / 9 | 9 / 9 | 7 / 8 | 9 / 10 |
| serious Total, serious adverse events | 0 / 16 | 2 / 9 | 1 / 9 | 0 / 9 | 0 / 8 | 4 / 10 |
Outcome results
Primary
Safety and Tolerability: Number of Patients Who Withdraw Due to TEAEs
Time frame: Day 1 to end of study (up to Day 182 [32 mg cohort]/ Day 210 [all other cohorts])
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pooled Placebo | Safety and Tolerability: Number of Patients Who Withdraw Due to TEAEs | 0 Participants |
| WVE-120101 (2 mg) | Safety and Tolerability: Number of Patients Who Withdraw Due to TEAEs | 1 Participants |
| WVE-120101 (4 mg) | Safety and Tolerability: Number of Patients Who Withdraw Due to TEAEs | 2 Participants |
| WVE-120101 (8 mg) | Safety and Tolerability: Number of Patients Who Withdraw Due to TEAEs | 0 Participants |
| WVE-120101 (16 mg) | Safety and Tolerability: Number of Patients Who Withdraw Due to TEAEs | 0 Participants |
| WVE-120101 (32 mg) | Safety and Tolerability: Number of Patients Who Withdraw Due to TEAEs | 2 Participants |
Primary
Safety: Number of Patients With Serious TEAEs
A serious TEAE is defined as any event that results in death, is immediately life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect not present at Prescreening.
Time frame: Day 1 to end of study (up to Day 182 [32 mg cohort]/ Day 210 [all other cohorts])
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pooled Placebo | Safety: Number of Patients With Serious TEAEs | 0 Participants |
| WVE-120101 (2 mg) | Safety: Number of Patients With Serious TEAEs | 2 Participants |
| WVE-120101 (4 mg) | Safety: Number of Patients With Serious TEAEs | 1 Participants |
| WVE-120101 (8 mg) | Safety: Number of Patients With Serious TEAEs | 0 Participants |
| WVE-120101 (16 mg) | Safety: Number of Patients With Serious TEAEs | 0 Participants |
| WVE-120101 (32 mg) | Safety: Number of Patients With Serious TEAEs | 4 Participants |
Primary
Safety: Number of Patients With Treatment-emergent Adverse Events (TEAEs)
All TEAEs reported or observed during the study, including TEAEs resulting from concurrent illnesses, reactions to concurrent medications, or progression of disease states
Time frame: Day 1 to end of study (up to Day 182 [32 mg cohort]/ Day 210 [all other cohorts])
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pooled Placebo | Safety: Number of Patients With Treatment-emergent Adverse Events (TEAEs) | 12 Participants |
| WVE-120101 (2 mg) | Safety: Number of Patients With Treatment-emergent Adverse Events (TEAEs) | 8 Participants |
| WVE-120101 (4 mg) | Safety: Number of Patients With Treatment-emergent Adverse Events (TEAEs) | 8 Participants |
| WVE-120101 (8 mg) | Safety: Number of Patients With Treatment-emergent Adverse Events (TEAEs) | 9 Participants |
| WVE-120101 (16 mg) | Safety: Number of Patients With Treatment-emergent Adverse Events (TEAEs) | 7 Participants |
| WVE-120101 (32 mg) | Safety: Number of Patients With Treatment-emergent Adverse Events (TEAEs) | 9 Participants |
Primary
Safety: Severity of Adverse Events
Number of patients who experienced a severe treatment-emergent adverse event. Severity was evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Time frame: Day 1 to end of study (up to Day 182 [32 mg cohort]/ Day 210 [all other cohorts])
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pooled Placebo | Safety: Severity of Adverse Events | 1 Participants |
| WVE-120101 (2 mg) | Safety: Severity of Adverse Events | 2 Participants |
| WVE-120101 (4 mg) | Safety: Severity of Adverse Events | 1 Participants |
| WVE-120101 (8 mg) | Safety: Severity of Adverse Events | 1 Participants |
| WVE-120101 (16 mg) | Safety: Severity of Adverse Events | 0 Participants |
| WVE-120101 (32 mg) | Safety: Severity of Adverse Events | 5 Participants |
Secondary
Clinical Effects: Total Functional Capacity (TFC)
Percentage change from baseline to the last measured time point in the Total Functional Capacity score, administered as part of the Unified Huntington's Disease Rating Scale (UHDRS). Total Functional Capacity is scored 13 (normal) to 0 (severe disability).
Time frame: Day 1 to last observation - up to Day 140 (32 mg cohort) or Day 196 (all other cohorts)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pooled Placebo | Clinical Effects: Total Functional Capacity (TFC) | 0.00 % Change from Baseline |
| WVE-120101 (2 mg) | Clinical Effects: Total Functional Capacity (TFC) | 0.00 % Change from Baseline |
| WVE-120101 (4 mg) | Clinical Effects: Total Functional Capacity (TFC) | 0.00 % Change from Baseline |
| WVE-120101 (8 mg) | Clinical Effects: Total Functional Capacity (TFC) | 0.00 % Change from Baseline |
| WVE-120101 (16 mg) | Clinical Effects: Total Functional Capacity (TFC) | 4.17 % Change from Baseline |
| WVE-120101 (32 mg) | Clinical Effects: Total Functional Capacity (TFC) | 0.00 % Change from Baseline |
Secondary
Pharmacodynamics
Percentage change from baseline in concentration of mutant huntingtin (mHTT) protein in CSF
Time frame: Day 1 to last observation - up to Day 140 (32 mg cohort) or Day 196 (all other cohorts)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pooled Placebo | Pharmacodynamics | -6.62 Percent change from baseline |
| WVE-120101 (2 mg) | Pharmacodynamics | -5.20 Percent change from baseline |
| WVE-120101 (4 mg) | Pharmacodynamics | -12.33 Percent change from baseline |
| WVE-120101 (8 mg) | Pharmacodynamics | -8.58 Percent change from baseline |
| WVE-120101 (16 mg) | Pharmacodynamics | -11.73 Percent change from baseline |
| WVE-120101 (32 mg) | Pharmacodynamics | -9.13 Percent change from baseline |
Secondary
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax)
Cmax of WVE-120101 in plasma
Time frame: Patients participating in Period 1 (SAD) had PK samples collected on Day 1 predose through 24-48 hours postdose. Patients participating in Period 2 (MAD) had PK samples collected predose on Day 112 and through 4 hours postdose.
Population: The PK population consists of all treated patients in the safety population with at least 1 post-dose plasma or CSF WVE-120101 concentration measurement. The number of overall participants analyzed represents the number with at least 1 postdose plasma or CSF measurement at Day 1. The overall number of patients was different for Day 112, and represents patients with at least 1 postdose plasma or CSF measurement at Day 112.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled Placebo | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) | Day 112 | 13.296 ng/mL | Standard Deviation 6.057 |
| Pooled Placebo | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) | Day 1 | 7.70 ng/mL | Standard Deviation 7.901 |
| WVE-120101 (2 mg) | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) | Day 1 | 23.54 ng/mL | Standard Deviation 18.139 |
| WVE-120101 (2 mg) | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) | Day 112 | 14.27 ng/mL | Standard Deviation 12.574 |
| WVE-120101 (4 mg) | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) | Day 1 | 32.82 ng/mL | Standard Deviation 22.964 |
| WVE-120101 (8 mg) | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) | Day 1 | 184.48 ng/mL | Standard Deviation 209.47 |
| WVE-120101 (16 mg) | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) | Day 1 | 229.01 ng/mL | Standard Deviation 168.33 |
Secondary
PK: Area Under the Plasma Concentration-time Curve (AUClast)
AUClast from time 0 to the last quantifiable concentration of WVE-120101 in plasma
Time frame: Patients participating in Period 1 (SAD) had PK samples collected on Day 1 predose through 24-48 hours postdose. Patients participating in Period 2 (MAD) had PK samples collected predose on Day 112 and through 4 hours postdose.
Population: The PK population consists of all treated patients in the safety population with at least 1 post-dose plasma or CSF WVE-120101 concentration measurement. The number of overall participants analyzed represents the number with at least 1 postdose plasma or CSF measurement at Day 1. The overall number of patients was different for Day 112, and represents patients with at least 1 postdose plasma or CSF measurement at Day 112.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled Placebo | PK: Area Under the Plasma Concentration-time Curve (AUClast) | Day 112 | 36.19 hr*ng/mL | Standard Deviation 20.135 |
| Pooled Placebo | PK: Area Under the Plasma Concentration-time Curve (AUClast) | Day 1 | 35.20 hr*ng/mL | Standard Deviation 16.037 |
| WVE-120101 (2 mg) | PK: Area Under the Plasma Concentration-time Curve (AUClast) | Day 1 | 90.77 hr*ng/mL | Standard Deviation 50.672 |
| WVE-120101 (2 mg) | PK: Area Under the Plasma Concentration-time Curve (AUClast) | Day 112 | 49.54 hr*ng/mL | Standard Deviation 34.735 |
| WVE-120101 (4 mg) | PK: Area Under the Plasma Concentration-time Curve (AUClast) | Day 1 | 255.14 hr*ng/mL | Standard Deviation 98.342 |
| WVE-120101 (8 mg) | PK: Area Under the Plasma Concentration-time Curve (AUClast) | Day 1 | 1133.74 hr*ng/mL | Standard Deviation 551.997 |
| WVE-120101 (16 mg) | PK: Area Under the Plasma Concentration-time Curve (AUClast) | Day 1 | 1968.31 hr*ng/mL | Standard Deviation 1188.173 |
Secondary
PK: Terminal Elimination Half Life
Terminal elimination half life of WVE-120101 in plasma (t1/2)
Time frame: Patients participating in Period 1 (SAD) had PK samples collected on Day 1 predose through 24-48 hours postdose. Patients participating in Period 2 (MAD) had PK samples collected predose on Day 112 and through 4 hours postdose.
Population: The t1/2 value was calculated using data from patients who had at least 3 postdose concentration values in the terminal phase. No patients had sufficient postdose samples at Day 112 to calculate t1/2 values.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| WVE-120101 (4 mg) | PK: Terminal Elimination Half Life | 8.12 hours |
| WVE-120101 (8 mg) | PK: Terminal Elimination Half Life | 12.30 hours |
| WVE-120101 (16 mg) | PK: Terminal Elimination Half Life | 14.38 hours |
Secondary
PK: Time of Occurrence of Cmax (Tmax)
tmax of WVE-120101 in plasma
Time frame: Patients participating in Period 1 (SAD) had PK samples collected on Day 1 predose through 24-48 hours postdose. Patients participating in Period 2 (MAD) had PK samples collected predose on Day 112 and through 4 hours postdose.
Population: The PK population consists of all treated patients in the safety population with at least 1 post-dose plasma or CSF WVE-120101 concentration measurement. The number of overall participants analyzed represents the number with at least 1 postdose plasma or CSF measurement at Day 1. The overall number of patients was different for Day 112, and represents patients with at least 1 postdose plasma or CSF measurement at Day 112.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled Placebo | PK: Time of Occurrence of Cmax (Tmax) | Day 112 | 1.99 hours | Standard Deviation 0.934 |
| Pooled Placebo | PK: Time of Occurrence of Cmax (Tmax) | Day 1 | 1.34 hours | Standard Deviation 1.103 |
| WVE-120101 (2 mg) | PK: Time of Occurrence of Cmax (Tmax) | Day 1 | 1.58 hours | Standard Deviation 1.081 |
| WVE-120101 (2 mg) | PK: Time of Occurrence of Cmax (Tmax) | Day 112 | 2.23 hours | Standard Deviation 1.175 |
| WVE-120101 (4 mg) | PK: Time of Occurrence of Cmax (Tmax) | Day 1 | 2.66 hours | Standard Deviation 1.391 |
| WVE-120101 (8 mg) | PK: Time of Occurrence of Cmax (Tmax) | Day 1 | 2.71 hours | Standard Deviation 3.068 |
| WVE-120101 (16 mg) | PK: Time of Occurrence of Cmax (Tmax) | Day 1 | 4.61 hours | Standard Deviation 7.054 |