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The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of single and multiple doses of ARO-HSD in healthy adult volunteers and in patients with NASH or suspected NASH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: ARO-HSD 25 mg | Experimental | Normal healthy volunteers randomized to double blind ARO-HSD 25 mg on Day 1 only. |
|
| Cohort 1: Placebo | Placebo Comparator | Normal healthy volunteers randomized to double blind placebo on Day 1 only. |
|
| Cohort 2: ARO-HSD 50 mg | Experimental | Normal healthy volunteers randomized to double blind ARO-HSD 50 mg on Day 1 only. |
|
| Cohort 2: Placebo | Placebo Comparator | Normal healthy volunteers randomized to double blind placebo on Day 1 only. |
|
| Cohort 3: ARO-HSD 100 mg | Experimental | Normal healthy volunteers randomized to double blind ARO-HSD 100 mg on Day 1 only. |
|
| Cohort 3: Placebo | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARO-HSD Injection | Drug | single or multiple doses of ARO-HSD by subcutaneous (sc) injections |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment | Adverse event (AE)=any untoward medical occurrence that does not necessarily have to have a causal relationship with this treatment. TEAEs=AEs with onset after administration of the study drug, or when a pre-existing medical condition increases in severity or frequency after study drug administration. Serious adverse event (SAE)= an AE that results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a medically important event or reaction. | From first dose of study drug through Day 113 (±5 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) of ARO-HSD: Plasma Concentrations | Normal Healthy Volunteers: Day 1: 2 hours pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 8, 12, 18, 24; Day 2: 48 hours post-dose, Days 8, 15, 29. NASH Participants: Day 1: 2 hours pre-dose, 30 minutes, 1, 2, 24, hours post-dose, Days 8, 15, 29 | |
| PK of ARO-HSD in Normal Healthy Volunteers: Maximum Observed Plasma Concentration (Cmax) |
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Inclusion Criteria:
Exclusion Criteria:
NOTE: additional inclusion/exclusion criteria may apply, per protocol
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Auckland Clinical Studies | Grafton | Auckland | 1010 | New Zealand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36513186 | Derived | Mak LY, Gane E, Schwabe C, Yoon KT, Heo J, Scott R, Lee JH, Lee JI, Kweon YO, Weltman M, Harrison SA, Neuschwander-Tetri BA, Cusi K, Loomba R, Given BD, Christianson DR, Garcia-Medel E, Yi M, Hamilton J, Yuen MF. A phase I/II study of ARO-HSD, an RNA interference therapeutic, for the treatment of non-alcoholic steatohepatitis. J Hepatol. 2023 Apr;78(4):684-692. doi: 10.1016/j.jhep.2022.11.025. Epub 2022 Dec 10. |
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Following Screening, Cohorts 1 through 4 (normal healthy volunteers) enrolled eligible participants, randomly assigned 1:1 to receive a single subcutaneous (SC) dose of ARO-HSD or placebo on Day 1. Per protocol, the placebo cohorts were pooled for data analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: ARO-HSD 25 mg | Normal healthy volunteers randomized to double blind ARO-HSD 25 mg on Day 1 only. |
| FG001 | Cohort 2: ARO-HSD 50 mg | Normal healthy volunteers randomized to double blind ARO-HSD 50 mg on Day 1 only. |
| FG002 | Cohort 3: ARO-HSD 100 mg | Normal healthy volunteers randomized to double blind ARO-HSD 100 mg on Day 1 only. |
| FG003 | Cohort 4: ARO-HSD 200 mg | Normal healthy volunteers randomized to double blind ARO-HSD 200 mg on Day 1 only. |
| FG004 | Cohorts 1-4: Pooled Placebo | Normal healthy volunteers randomized to double blind placebo on Day 1 only. |
| FG005 | Cohort 1b: ARO-HSD 25 mg | Participants with suspected non-alcoholic steatohepatitis (NASH) receive open-label ARO-HSD 25 mg on Days 1 and 29. |
| FG006 | Cohort 3b: ARO-HSD 100 mg | Participants with suspected NASH receive open-label ARO-HSD 100 mg on Days 1 and 29. |
| FG007 | Cohort 4b: ARO-HSD 200 mg | Participants with suspected NASH received open-label ARO-HSD 200 mg on Days 1 and 29. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: ARO-HSD 25 mg | Normal healthy volunteers randomized to double blind ARO-HSD 25 mg on Day 1 only. |
| BG001 | Cohort 2: ARO-HSD 50 mg | Normal healthy volunteers randomized to double blind ARO-HSD 50 mg on Day 1 only. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment | Adverse event (AE)=any untoward medical occurrence that does not necessarily have to have a causal relationship with this treatment. TEAEs=AEs with onset after administration of the study drug, or when a pre-existing medical condition increases in severity or frequency after study drug administration. Serious adverse event (SAE)= an AE that results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a medically important event or reaction. | Safety Population: all enrolled participants who received at least one dose of active drug or placebo. | Posted | Number | participants | From first dose of study drug through Day 113 (±5 days) |
|
Screening through Day 113 (±5 days)
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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 | Cohort 1: ARO-HSD 25 mg | Normal healthy volunteers randomized to double blind ARO-HSD 25 mg on Day 1 only. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Soft Tissue Injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Operating Officer | Arrowhead Pharmaceuticals, Inc. | 1 (626) 304-3400 | info@arrowheadpharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 12, 2021 | Jul 21, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 16, 2021 | Jul 21, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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Normal healthy volunteers randomized to double blind placebo on Day 1 only. |
|
| Cohort 4: ARO-HSD 200 mg | Experimental | Normal healthy volunteers randomized to double blind ARO-HSD 200 mg on Day 1 only. |
|
| Cohort 4: Placebo | Placebo Comparator | Normal healthy volunteers randomized to double blind placebo on Day 1 only. |
|
| Cohort 1b: ARO-HSD 25 mg | Experimental | Participants with suspected non-alcoholic steatohepatitis (NASH) receive open-label ARO-HSD 25 mg on Days 1 and 29. |
|
| Cohort 3b: ARO-HSD 100 mg | Experimental | Participants with suspected NASH receive open-label ARO-HSD 100 mg on Days 1 and 29. |
|
| Cohort 4b: ARO-HSD 200 mg | Experimental | Participants with suspected NASH receive open-label ARO-HSD 200 mg on Days 1 and 29. |
|
| sterile normal saline (0.9% NaCl) | Drug | calculated volume to match active treatment, by sc injection |
|
| Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24, 48 hours postdose |
| PK of ARO-HSD in Normal Healthy Volunteers: Time to Reach Cmax (Tmax) | Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24, 48 hours postdose |
| PK of ARO-HSD in Normal Healthy Volunteers: Terminal Elimination Half-Life (t1/2) | Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24, 48 hours postdose |
| PK of ARO-HSD in Normal Healthy Volunteers: Area Under the Concentration-Time Curve From Dosing (Time 0) to the Time of the Last Measured Concentration (AUClast) | Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24, 48 hours postdose |
| PK of ARO-HSD in Normal Healthy Volunteers: Area Under the Curve From Time 0 to Infinity (AUCinf) | Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24, 48 hours postdose |
| Secondary: PK of ARO-HSD in Normal Healthy Volunteers: Oral Clearance (CL/F) | Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24, 48 hours postdose |
| PK of ARO-HSD in Normal Healthy Volunteers: Apparent Volume of Distribution During the Terminal-Phase (Vz/F) | Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24, 48 hours postdose |
| Urine PK of ARO-HSD in Normal Healthy Volunteers: Amount of Unchanged Drug Recovered in Urine Over 0-24 Hours Postdose (Ae0-24h) | Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24 hours postdose |
| Urine PK of ARO-HSD in Normal Healthy Volunteers: Percentage of the Administrated Drug Recovered in Urine Over 0-24 Hours (Fe0-24h) | Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24 hours postdose |
| Urine PK of ARO-HSD in Normal Healthy Volunteers: Renal Clearance (CLr) | Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24 hours postdose |
| BG002 | Cohort 3: ARO-HSD 100 mg | Normal healthy volunteers randomized to double blind ARO-HSD 100 mg on Day 1 only. |
| BG003 | Cohort 4: ARO-HSD 200 mg | Normal healthy volunteers randomized to double blind ARO-HSD 200 mg on Day 1 only. |
| BG004 | Cohorts 1-4: Pooled Placebo | Normal healthy volunteers randomized to double blind placebo on Day 1 only. |
| BG005 | Cohort 1b: ARO-HSD 25 mg | Participants with suspected NASH receive open-label ARO-HSD 25 mg on Days 1 and 29. |
| BG006 | Cohort 3b: ARO-HSD 100 mg | Participants with suspected NASH receive open-label ARO-HSD 100 mg on Days 1 and 29. |
| BG007 | Cohort 4b: ARO-HSD 200 mg | Participants with suspected NASH received open-label ARO-HSD 200 mg on Days 1 and 29. |
| BG008 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
Normal healthy volunteers randomized to double blind ARO-HSD 25 mg on Day 1 only. |
| OG001 | Cohort 2: ARO-HSD 50 mg | Normal healthy volunteers randomized to double blind ARO-HSD 50 mg on Day 1 only. |
| OG002 | Cohort 3: ARO-HSD 100 mg | Normal healthy volunteers randomized to double blind ARO-HSD 100 mg on Day 1 only. |
| OG003 | Cohort 4: ARO-HSD 200 mg | Normal healthy volunteers randomized to double blind ARO-HSD 200 mg on Day 1 only. |
| OG004 | Cohorts 1-4: Pooled Placebo | Normal healthy volunteers randomized to double blind placebo on Day 1 only. |
| OG005 | Cohort 1b: ARO-HSD 25 mg | Participants with suspected non-alcoholic steatohepatitis (NASH) receive open-label ARO-HSD 25 mg on Days 1 and 29. |
| OG006 | Cohort 3b: ARO-HSD 100 mg | Participants with suspected NASH receive open-label ARO-HSD 100 mg on Days 1 and 29. |
| OG007 | Cohort 4b: ARO-HSD 200 mg | Participants with suspected NASH received open-label ARO-HSD 200 mg on Days 1 and 29. |
|
|
| Secondary | Pharmacokinetics (PK) of ARO-HSD: Plasma Concentrations | PK Analysis Set: all participants who received at least one dose of active study treatment and had sufficient plasma concentration data to characterize PK profile. Participants with sufficient data at given time point. | Posted | Mean | Standard Deviation | ng/mL | Normal Healthy Volunteers: Day 1: 2 hours pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 8, 12, 18, 24; Day 2: 48 hours post-dose, Days 8, 15, 29. NASH Participants: Day 1: 2 hours pre-dose, 30 minutes, 1, 2, 24, hours post-dose, Days 8, 15, 29 |
|
|
|
| Secondary | PK of ARO-HSD in Normal Healthy Volunteers: Maximum Observed Plasma Concentration (Cmax) | PK Analysis Set: all participants who received at least one dose of active study treatment and had sufficient plasma concentration data to characterize PK profile. Normal healthy volunteer cohorts only. | Posted | Mean | Standard Deviation | ng/mL | Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24, 48 hours postdose |
|
|
|
| Secondary | PK of ARO-HSD in Normal Healthy Volunteers: Time to Reach Cmax (Tmax) | PK Analysis Set: all participants who received at least one dose of active study treatment and had sufficient plasma concentration data to characterize PK profile. Normal healthy volunteer cohorts only. | Posted | Median | Full Range | hours | Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24, 48 hours postdose |
|
|
|
| Secondary | PK of ARO-HSD in Normal Healthy Volunteers: Terminal Elimination Half-Life (t1/2) | PK Analysis Set: all participants who received at least one dose of active study treatment and had sufficient plasma concentration data to characterize PK profile. Normal healthy volunteer cohorts only. | Posted | Mean | Standard Deviation | hours | Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24, 48 hours postdose |
|
|
|
| Secondary | PK of ARO-HSD in Normal Healthy Volunteers: Area Under the Concentration-Time Curve From Dosing (Time 0) to the Time of the Last Measured Concentration (AUClast) | PK Analysis Set: all participants who received at least one dose of active study treatment and had sufficient plasma concentration data to characterize PK profile. Normal healthy volunteer cohorts only. | Posted | Mean | Standard Deviation | h*ng/mL | Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24, 48 hours postdose |
|
|
|
| Secondary | PK of ARO-HSD in Normal Healthy Volunteers: Area Under the Curve From Time 0 to Infinity (AUCinf) | PK Analysis Set: all participants who received at least one dose of active study treatment and had sufficient plasma concentration data to characterize PK profile. Normal healthy volunteer cohorts only. | Posted | Mean | Standard Deviation | h*ng/mL | Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24, 48 hours postdose |
|
|
|
| Secondary | Secondary: PK of ARO-HSD in Normal Healthy Volunteers: Oral Clearance (CL/F) | PK Analysis Set: all participants who received at least one dose of active study treatment and had sufficient plasma concentration data to characterize PK profile. Normal healthy volunteer cohorts only. | Posted | Mean | Standard Deviation | L/hour | Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24, 48 hours postdose |
|
|
|
| Secondary | PK of ARO-HSD in Normal Healthy Volunteers: Apparent Volume of Distribution During the Terminal-Phase (Vz/F) | PK Analysis Set: all participants who received at least one dose of active study treatment and had sufficient plasma concentration data to characterize PK profile. Normal healthy volunteer cohorts only. | Posted | Mean | Standard Deviation | L | Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24, 48 hours postdose |
|
|
|
| Secondary | Urine PK of ARO-HSD in Normal Healthy Volunteers: Amount of Unchanged Drug Recovered in Urine Over 0-24 Hours Postdose (Ae0-24h) | PK Analysis Set: all participants who received at least one dose of active study treatment and had sufficient plasma concentration data to characterize PK profile. Normal healthy volunteer cohorts only. | Posted | Mean | Standard Deviation | mg | Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24 hours postdose |
|
|
|
| Secondary | Urine PK of ARO-HSD in Normal Healthy Volunteers: Percentage of the Administrated Drug Recovered in Urine Over 0-24 Hours (Fe0-24h) | PK Analysis Set: all participants who received at least one dose of active study treatment and had sufficient plasma concentration data to characterize PK profile. Normal healthy volunteer cohorts only. | Posted | Mean | Standard Deviation | percentage of study drug | Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24 hours postdose |
|
|
|
| Secondary | Urine PK of ARO-HSD in Normal Healthy Volunteers: Renal Clearance (CLr) | PK Analysis Set: all participants who received at least one dose of active study treatment and had sufficient plasma concentration data to characterize PK profile. Normal healthy volunteer cohorts only. | Posted | Mean | Standard Deviation | L/hour | Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24 hours postdose |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 4 |
| 4 |
| EG001 | Cohort 2: ARO-HSD 50 mg | Normal healthy volunteers randomized to double blind ARO-HSD 50 mg on Day 1 only. | 0 | 4 | 0 | 4 | 1 | 4 |
| EG002 | Cohort 3: ARO-HSD 100 mg | Normal healthy volunteers randomized to double blind ARO-HSD 200 mg on Day 1 only. | 0 | 4 | 0 | 4 | 4 | 4 |
| EG003 | Cohort 4: ARO-HSD 200 mg | Normal healthy volunteers randomized to double blind ARO-HSD ≤ 200 mg on Day 1 only | 0 | 4 | 0 | 4 | 3 | 4 |
| EG004 | Cohorts 1-4: Pooled Placebo | Normal healthy volunteers randomized to double blind placebo on Day 1 only. | 0 | 16 | 0 | 16 | 10 | 16 |
| EG005 | Cohort 1b: ARO-HSD 25 mg | Participants with suspected non-alcoholic steatohepatitis (NASH) receive open-label ARO-HSD 25 mg on Days 1 and 29. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG006 | Cohort 3b: ARO-HSD 100 mg | Participants with suspected NASH receive open-label ARO-HSD 100 mg on Days 1 and 29. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG007 | Cohort 4b: ARO-HSD 200 mg | Participants with suspected NASH received open-label ARO-HSD 200 mg on Days 1 and 29. | 0 | 6 | 1 | 6 | 4 | 6 |
| Palpitations | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
|
| Blepharospasm | Eye disorders | MedDRA 23.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 23.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Morning sickness | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Mouth ulceration | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Injection site bruising | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Medical device site reaction | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Postoperative wound infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Pulpitis dental | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Nerve injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Eye injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Limb injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Heavy menstrual bleeding | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
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| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Dental caries | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Tendon injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor retains first right to publish results for this multi-center study, and thereafter can review results communications prior to release and can embargo communications regarding trial results for a period that is 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication of results but can require removal of its confidential information (excluding results).
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| 15 minutes post-dose |
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| 30 minutes post-dose |
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| 1 hour post-dose |
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| 2 hours post-dose |
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| 4 hours post-dose |
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| 8 hours post-dose |
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| 18 hours post-dose |
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| 24 hours post-dose |
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| 48 hours post-dose |
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| Day 8 |
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| Day 15 |
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| Day 29 |
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