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This study is the first study in the RestorAATion clinical program.
The purpose of this first-in human (FIH), double-blind, randomized, placebo-controlled, single ascending dose (SAD) and multiple-dose Phase 1 study is to assess the safety, tolerability, and pharmacokinetics (PK) of WVE-006 compared to placebo in healthy participants following a single dose (Period 1) and multiple doses (Period 2) of WVE-006.
This information will be used to determine doses and regimes that have the potential to be pharmacologically active in patients with Alpha-1 antitrypsin deficiency in the RestorAATion 2 study, and the maximum safe and tolerable dose that may be given to these patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Ascending Dose (SAD): WVE-006 30 milligram (mg) or placebo | Experimental |
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| SAD: WVE-006 100 mg or placebo | Experimental |
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| SAD WVE-006 200 mg or placebo | Experimental |
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| SAD: WVE-006 400 mg or placebo | Experimental |
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| SAD: WVE-006 600 mg or placebo | Experimental |
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| Multiple Dose: WVE-006 600 mg Every 2 weeks (Q2W) or placebo | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WVE-006 | Drug | RNA editing oligonucleotide |
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| Measure | Description | Time Frame |
|---|---|---|
| The Proportion of Participants With Adverse Events | The number of participants who reported an adverse event (AE) will be summarised. | Adverse events are collected from the date of consent until up to 85 days after the dose in Period 1 and up to 113 days after the first dose in Period 2. |
| Measure | Description | Time Frame |
|---|---|---|
| Single Ascending Dose (Period 1) - Area Under the Plasma Concentration Time Curve for WVE-006 From Time of Dosing to the Last Measurable Concentration (AUClast) | Plasma samples were obtained in order to evaluate defined plasma pharmacokinetic parameters for WVE-006. This endpoint will report the summary of derived pharmacokinetic parameters for the Area under the plasma concentration time curve for WVE-006 from time of dosing to the last measurable concentration (AUClast) of WVE-006 in plasma for participants in Period 1 of the study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia Caracta, MD | Wave Life Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Simbec-Orion Clinical Pharmacology, | Merthyr Tydfil | Wales | CF48 4DR | United Kingdom |
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Participants were screened to the inclusion/exclusion of the protocol. The following assessments were performed: Consent, Demographics, Medical History, Prior/Concomitant Medications, AAT Testing, Pregnancy/FSH, Vital signs, Physical examination, Laboratory Safety Testing, ECG, Urine Drugs of Abuse Testing .
The study included 2 distinct periods: Period 1 (SAD) and Period 2 (multiple dose). A total of 39 participants were randomised to Period 1 and 8 participants were randomised to Period 2.
Study recruitment was undertaken at one site in the United Kingdom. The recruitment process began in November 2023 and concluded in October 2024. A sufficient number of volunteers were screened in order to successfully recruit 46 completing participants (with one participant withdrawal).
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| ID | Title | Description |
|---|---|---|
| FG000 | Period 1: Pooled Placebo | Participants were randomised to receive a single dose of placebo on Day 1 |
| FG001 | Period 1 Cohort 1 - WVE-006 30 mg | Participants were randomised to receive a single dose of WVE-006 30 mg on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 29, 2023 |
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| Samples collected at the following timepoints: Day 1 pre-dose, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr & 12 hr post-Day 1 dose, Day 2: 24 hr & 36 hr post-Day 1 dose, Day 3: 48 hr post-Day 1 dose, Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78 & 85. |
| Single Ascending Dose - Maximum Concentration of WVE-006 in Plasma (Cmax) | Plasma samples were obtained in order to evaluate defined plasma pharmacokinetic parameters for WVE-006. This endpoint will report the summary of derived pharmacokinetic parameters for the Maximum concentration of WVE-006 in plasma (Cmax) of WVE-006 in plasma for participants in Period 1 of the study. | Samples collected at the following timepoints: Day 1 pre-dose, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr & 12 hr post-Day 1 dose, Day 2: 24 hr & 36 hr post-Day 1 dose, Day 3: 48 hr post-Day 1 dose, Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78 & 85. |
| Multiple Ascending Doses - Area Under the Plasma Concentration Time Curve for WVE-006 From Time of Dosing to the Last Measurable Concentration (AUClast) - Day 1 | Plasma samples were obtained in order to evaluate defined plasma pharmacokinetic parameters for WVE-006. This endpoint will report the summary of derived pharmacokinetic parameters for the Area under the plasma concentration time curve for WVE-006 from time of dosing to the last measurable concentration (AUClast) of WVE-006 in plasma for participants in Period 2 of the study. | Samples collected at the following timepoints for Day 1 measurement: Day 1 pre-dose, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr & 24 hr post-dose. |
| Multiple Ascending Doses - Maximum Concentration of WVE-006 in Plasma (Cmax) - Day 1 | Plasma samples were obtained in order to evaluate defined plasma pharmacokinetic parameters for WVE-006. This endpoint will report the summary of derived pharmacokinetic parameters for the Maximum concentration of WVE-006 in plasma (Cmax) of WVE-006 in plasma for participants in Period 2 of the study. | Samples collected at the following timepoints for Day 1 measurement: Day 1 pre-dose, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr & 24 hr post-dose. |
| Multiple Ascending Doses - Area Under the Plasma Concentration Time Curve for WVE-006 From Time of Dosing to the Last Measurable Concentration (AUClast) - Day 29 | Plasma samples were obtained in order to evaluate defined plasma pharmacokinetic parameters for WVE-006. This endpoint will report the summary of derived pharmacokinetic parameters for the Area under the plasma concentration time curve for WVE-006 from time of dosing to the last measurable concentration (AUClast) of WVE-006 in plasma for participants in Period 2 of the study. | Samples collected at the following timepoints for Day 29 measurement: Day 29 pre-dose, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr & 24 hr post-dose. |
| Multiple Ascending Doses - Maximum Concentration of WVE-006 in Plasma (Cmax) - Day 29 | Plasma samples were obtained in order to evaluate defined plasma pharmacokinetic parameters for WVE-006. This endpoint will report the summary of derived pharmacokinetic parameters for the Maximum concentration of WVE-006 in plasma (Cmax) of WVE-006 in plasma for participants in Period 2 of the study. | Samples collected at the following timepoints for Day 29 measurement: Day 29 pre-dose, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr & 24 hr post-dose. |
| FG002 | Period 1 Cohort 2 - WVE-006 100 mg | Participants were randomised to receive a single dose of WVE-006 100 mg on Day 1. |
| FG003 | Period 1 Cohort 3 - WVE-006 200 mg | Participants were randomised to receive a single dose of WVE-006 200 mg on Day 1. |
| FG004 | Period 1 Cohort 4 - WVE-006 400 mg | Participants were randomised to receive a single dose of WVE-006 400 mg on Day 1. |
| FG005 | Period 1 Cohort 5 - WVE-006 600 mg | Participants were randomised to receive a single dose of WVE-006 600 mg on Day 1. |
| FG006 | Period 2 Cohort 1 - WVE-006 600 mg Q2W | Participants were randomised to receive WVE-006 600 mg Q2W for 3 doses (on Day 1, Day 15 & Day 29). |
| FG007 | Period 2 Cohort 1 - Placebo Q2W | Participants were randomised to receive placebo Q2W for 3 doses (on Day 1, Day 15 & Day 29). |
| COMPLETED |
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| NOT COMPLETED |
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This analysis population included all 47 enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Period 1: Pooled Placebo | Participants were randomised to receive a single dose of placebo on Day 1. |
| BG001 | Period 1 Cohort 1 - WVE-006 30 mg | Participants were randomised to receive a single dose of WVE-006 30 mg on Day 1. |
| BG002 | Period 1 Cohort 2 - WVE-006 100 mg | Participants were randomised to receive a single dose of WVE-006 100 mg on Day 1. |
| BG003 | Period 1 Cohort 3 - WVE-006 200 mg | Participants were randomised to receive a single dose of WVE-006 200 mg on Day 1. |
| BG004 | Period 1 Cohort 4 - WVE-006 400 mg | Participants were randomised to receive a single dose of WVE-006 400 mg on Day 1. |
| BG005 | Period 1 Cohort 5 - WVE-006 600 mg | Participants were randomised to receive a single dose of WVE-006 600 mg on Day 1. |
| BG006 | Period 2 Cohort 1 - WVE-006 600 mg Q2W | Participants were randomised to receive WVE-006 600 mg Q2W for 3 doses (on Day 1, Day 15 & Day 29). |
| BG007 | Period 2 Cohort 1 - Placebo Q2W | Participants were randomised to receive placebo Q2W for 3 doses (on Day 1, Day 15 & Day 29). |
| BG008 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Weight | Mean | Standard Deviation | Kilograms |
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| Height | Mean | Standard Deviation | Metres |
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| Body Mass Index | Mean | Standard Deviation | Kilograms per metre 2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Proportion of Participants With Adverse Events | The number of participants who reported an adverse event (AE) will be summarised. | This analysis population included 47 enrolled participants who received at least one dose of WVE-006 or matching placebo. | Posted | Count of Participants | Participants | Adverse events are collected from the date of consent until up to 85 days after the dose in Period 1 and up to 113 days after the first dose in Period 2. |
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| Secondary | Single Ascending Dose (Period 1) - Area Under the Plasma Concentration Time Curve for WVE-006 From Time of Dosing to the Last Measurable Concentration (AUClast) | Plasma samples were obtained in order to evaluate defined plasma pharmacokinetic parameters for WVE-006. This endpoint will report the summary of derived pharmacokinetic parameters for the Area under the plasma concentration time curve for WVE-006 from time of dosing to the last measurable concentration (AUClast) of WVE-006 in plasma for participants in Period 1 of the study. | This analysis population includes the 29 participants who received at least one dose of WVE-006 and were selected as part of the PK analysis set for Period 1. | Posted | Mean | Standard Deviation | h*ng/mL | Samples collected at the following timepoints: Day 1 pre-dose, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr & 12 hr post-Day 1 dose, Day 2: 24 hr & 36 hr post-Day 1 dose, Day 3: 48 hr post-Day 1 dose, Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78 & 85. |
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| Secondary | Single Ascending Dose - Maximum Concentration of WVE-006 in Plasma (Cmax) | Plasma samples were obtained in order to evaluate defined plasma pharmacokinetic parameters for WVE-006. This endpoint will report the summary of derived pharmacokinetic parameters for the Maximum concentration of WVE-006 in plasma (Cmax) of WVE-006 in plasma for participants in Period 1 of the study. | This analysis population includes the 29 participants who received at least one dose of WVE-006 and were selected as part of the PK analysis set for Period 1. | Posted | Mean | Standard Deviation | ng/mL | Samples collected at the following timepoints: Day 1 pre-dose, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr & 12 hr post-Day 1 dose, Day 2: 24 hr & 36 hr post-Day 1 dose, Day 3: 48 hr post-Day 1 dose, Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78 & 85. |
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| Secondary | Multiple Ascending Doses - Area Under the Plasma Concentration Time Curve for WVE-006 From Time of Dosing to the Last Measurable Concentration (AUClast) - Day 1 | Plasma samples were obtained in order to evaluate defined plasma pharmacokinetic parameters for WVE-006. This endpoint will report the summary of derived pharmacokinetic parameters for the Area under the plasma concentration time curve for WVE-006 from time of dosing to the last measurable concentration (AUClast) of WVE-006 in plasma for participants in Period 2 of the study. | This analysis population includes the 6 participants who received all doses of WVE-006 and were selected as part of the PK analysis set for Period 2. | Posted | Mean | Standard Deviation | h*ng/mL | Samples collected at the following timepoints for Day 1 measurement: Day 1 pre-dose, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr & 24 hr post-dose. |
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| Secondary | Multiple Ascending Doses - Maximum Concentration of WVE-006 in Plasma (Cmax) - Day 1 | Plasma samples were obtained in order to evaluate defined plasma pharmacokinetic parameters for WVE-006. This endpoint will report the summary of derived pharmacokinetic parameters for the Maximum concentration of WVE-006 in plasma (Cmax) of WVE-006 in plasma for participants in Period 2 of the study. | This analysis population includes the 6 participants who received all doses of WVE-006 and were selected as part of the PK analysis set for Period 2. | Posted | Mean | Standard Deviation | ng/mL | Samples collected at the following timepoints for Day 1 measurement: Day 1 pre-dose, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr & 24 hr post-dose. |
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| Secondary | Multiple Ascending Doses - Area Under the Plasma Concentration Time Curve for WVE-006 From Time of Dosing to the Last Measurable Concentration (AUClast) - Day 29 | Plasma samples were obtained in order to evaluate defined plasma pharmacokinetic parameters for WVE-006. This endpoint will report the summary of derived pharmacokinetic parameters for the Area under the plasma concentration time curve for WVE-006 from time of dosing to the last measurable concentration (AUClast) of WVE-006 in plasma for participants in Period 2 of the study. | This analysis population includes the 6 participants who received all doses of WVE-006 and were selected as part of the PK analysis set for Period 2. | Posted | Mean | Standard Deviation | h*ng/mL | Samples collected at the following timepoints for Day 29 measurement: Day 29 pre-dose, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr & 24 hr post-dose. |
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| Secondary | Multiple Ascending Doses - Maximum Concentration of WVE-006 in Plasma (Cmax) - Day 29 | Plasma samples were obtained in order to evaluate defined plasma pharmacokinetic parameters for WVE-006. This endpoint will report the summary of derived pharmacokinetic parameters for the Maximum concentration of WVE-006 in plasma (Cmax) of WVE-006 in plasma for participants in Period 2 of the study. | This analysis population includes the 6 participants who received all doses of WVE-006 and were selected as part of the PK analysis set for Period 2. | Posted | Mean | Standard Deviation | ng/mL | Samples collected at the following timepoints for Day 29 measurement: Day 29 pre-dose, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr & 24 hr post-dose. |
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Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Period 1: Pooled Placebo | Participants were randomised to receive a single dose of placebo on Day 1. | 0 | 10 | 0 | 10 | 8 | 10 |
| EG001 | Period 1 Cohort 1 - WVE-006 30 mg | Participants were randomised to receive a single dose of WVE-006 30 mg on Day 1. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG002 | Period 1 Cohort 2 - WVE-006 100 mg | Participants were randomised to receive a single dose of WVE-006 100 mg on Day 1. | 0 | 5 | 0 | 5 | 4 | 5 |
| EG003 | Period 1 Cohort 3 - WVE-006 200 mg | Participants were randomised to receive a single dose of WVE-006 200 mg on Day 1. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG004 | Period 1 Cohort 4 - WVE-006 400 mg | Participants were randomised to receive a single dose of WVE-006 400 mg on Day 1. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG005 | Period 1 Cohort 5 - WVE-006 600 mg | Participants were randomised to receive a single dose of WVE-006 600 mg on Day 1. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG006 | Period 2 Cohort 1 - WVE-006 600 mg Q2W | Participants were randomised to receive WVE-006 600 mg Q2W for 3 doses (on Day 1, Day 15 & Day 29). | 0 | 6 | 0 | 6 | 2 | 6 |
| EG007 | Period 2 Cohort 1 - Placebo Q2W | Participants were randomised to receive placebo Q2W for 3 doses (on Day 1, Day 15 & Day 29). | 0 | 2 | 0 | 2 | 1 | 2 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood Creatinine Phosphokinase Increased | Investigations | MedDRA (26.1) | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (26.1) | Non-systematic Assessment |
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| Influenza like Illness | Infections and infestations | MedDRA (26.1) | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (26.1) | Non-systematic Assessment |
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| Transaminases Increased | Investigations | MedDRA (26.1) | Non-systematic Assessment |
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| Abdominal Discomfort | Gastrointestinal disorders | MedDRA (26.1) | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Non-systematic Assessment |
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| Catheter Site Pain | Investigations | MedDRA (26.1) | Non-systematic Assessment |
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| Dysmenorrhoea | Gastrointestinal disorders | MedDRA (26.1) | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (26.1) | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA (26.1) | Non-systematic Assessment |
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| Injection Site Reaction | General disorders | MedDRA (26.1) | Non-systematic Assessment |
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| Oropharyngeal Pain | Gastrointestinal disorders | MedDRA (26.1) | Non-systematic Assessment |
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| Pollakuria | Renal and urinary disorders | MedDRA (26.1) | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Non-systematic Assessment |
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| Thermal Burn | Injury, poisoning and procedural complications | MedDRA (26.1) | Non-systematic Assessment |
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| Toothache | Injury, poisoning and procedural complications | MedDRA (26.1) | Non-systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Non-systematic Assessment |
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| Dizziness | Ear and labyrinth disorders | MedDRA (26.1) | Non-systematic Assessment |
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| Rash Erythematous | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Non-systematic Assessment |
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| Skin Abrasion | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Wave Life Sciences UK Limited | +1-855-215-4687 | clinicaltrials@wavelifesci.com |
| Jan 27, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D019896 | alpha 1-Antitrypsin Deficiency |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D013352 | Subcutaneous Emphysema |
| D004646 | Emphysema |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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Participants were randomised to receive a single dose of WVE-006 200 mg on Day 1. |
| OG003 | Period 1 Cohort 4 - WVE-006 400 mg | Participants were randomised to receive a single dose of WVE-006 400 mg on Day 1. |
| OG004 | Period 1 Cohort 5 - WVE-006 600 mg | Participants were randomised to receive a single dose of WVE-006 600 mg on Day 1. |
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| OG003 | Period 1 Cohort 4 - WVE-006 400 mg | Participants were randomised to receive a single dose of WVE-006 400 mg on Day 1. |
| OG004 | Period 1 Cohort 5 - WVE-006 600 mg | Participants were randomised to receive a single dose of WVE-006 600 mg on Day 1. |
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