Healthy Volunteers
Conditions
Brief summary
The purpose of this study is to evaluate bioavailability of lanadelumab (SHP643) following a single, 2 milliliter (mL) subcutaneous (SC) dose of 300 milligrams (mg) delivered by prefilled syringe (PFS) or auto injector (AI) in healthy adult participants.
Interventions
DRUGSHP643
Participants will receive injection of SHP643.
Sponsors
Shire
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* An understanding, ability, and willingness to fully comply with study procedures and restrictions. * Ability to voluntarily provide written, signed, and dated informed consent to participate in the study. * Age 18-55, inclusive, at the time of consent. The date of signature of the informed consent is defined as the beginning of the screening period. This inclusion criterion will only be assessed at the first screening visit. * Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol or females of non-childbearing potential. * Must be considered healthy, per the investigator. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram (ECG), hematology, blood chemistry, and urinalysis. * Body mass index between 18.5-33 kilogram per square meter (kg/m\^2), inclusive, with a body weight greater than or equal to (\>=) 45 kilogram (kg) (99 pounds \[lbs\]). This inclusion criterion will only be assessed at the screening visit and on Day -1. * Willing and able to consume standardized meals during the confinement period of the study. * All participants will be required to consume the identical meals on study days when serial PK blood samples are collected
Exclusion criteria
* Per the investigator, a history of any hematological, hepatic, respiratory, cardiovascular, renal, neurological or psychiatric disease, gall bladder removal, or current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or clinical or laboratory assessments. * Per the investigator, a current or relevant history of physical or psychiatric illness, any medical disorder that may require treatment or make the participant unlikely to complete the study, or any condition that present's undue risk from the investigational product or procedures. * Known or suspected intolerance or hypersensitivity to the investigational product, closelyrelated compounds, or any of the stated ingredients. * Significant illness, as judged by the investigator, within 2 weeks of the dose of investigational product. * Known history of alcohol or other substance abuse within the last year, per the investigator. * Donation of blood or blood products (e.g. plasma or platelets) within 60 days prior to receiving the dose of investigational product. * Within 30 days prior to the dose of investigational product. 1. Have used an investigational product (if elimination half-life is \<6 days, otherwise 5 half lives). 2. Have been enrolled in a clinical study (including vaccine studies) that, in the investigator's opinion, may impact this Shire-sponsored study. * Confirmed systolic blood pressure (BP) \>139 millimeters of mercury (mmHg) or \<89 mmHg, and diastolic BP \>89 mmHg or \<49 mmHg. * Twelve-lead ECG values demonstrating QTcF \>450 milliseconds (msec) (males) or \>470 msec (females) at the screening visit or Day -1. If QTcF exceeds 450 msec (males) or 470 msec (females), the ECG should be repeated 2 more times and the average of the 3 QTcF values should be used to determine the participants eligibility. * Positive screen for drugs of abuse and/or disallowed drugs (i.e. amphetamines, benzodiazepines, barbiturates, cocaine, opiates, phencyclidine) at screening, or drugs of abuse or alcohol on Day -1. This screen will include marijuana. * Male participants who consume more than 21 units of alcohol per week or 3 units per day. Female participants who consume more than 14 units of alcohol per week or 2 units per day. One alcohol unit=1 beer or 1 wine (5 ounces \[oz) per 150 milliliter \[mL\]) or 1 liquor (1.5 oz/40 mL) or 0.75 oz alcohol. * Positive human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody screen. * Use of tobacco in any form (e.g. smoking or chewing) or other nicotine-containing products in any form (e.g. gum, patch, electronic). Ex-users must report that they have stopped using tobacco for at least 30 days prior to receiving the dose of investigational product. * Routine consumption of more than 2 units of caffeine per day or participants who experience caffeine withdrawal headaches. One caffeine unit is contained in the following items: one 6 oz (180 ml) cup of coffee, two 12 oz (360 ml) cans of cola, one 12 oz cup of tea, and three 1 oz (85 g) chocolate bars. Decaffeinated coffee, tea, or cola are not considered to contain caffeine). * Current use of any medication (including over-the-counter, herbal, or homeopathic preparations; with the exception of stable hormonal replacement therapy or hormonal contraceptives). Current use is defined as use within 14 days of the dose of investigational product. (Prior and Concomitant Treatment) for a list of permitted medications. * Abnormal laboratory values considered clinically significant, as determined by the investigator, at screening or Day -1. * History of any clinically significant surgery or procedure within 8 weeks of receiving the dose of investigational product, as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Terminal Elimination Rate Constant (Lambda z) of SHP643 in Plasma | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post-dose | Lambda z of SHP643 in Plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported. |
| Apparent Total Body Clearance for Extravascular Administration Divided by the Fraction of Dose Absorbed (CL/F) of SHP643 in Plasma | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post-dose | CL/F of of SHP643 in plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported. |
| Apparent Volume of Distribution Associated With the Terminal Slope Following Extravascular Administration Divided by the Fraction of Dose Absorbed (Vdz/F) of SHP643 in Plasma | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post-dose | Vdz/F of SHP643 in plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported. |
| Area Under the Concentration Versus Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of SHP643 in Plasma | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post dose | AUC(0-last) of SHP643 in plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported. |
| Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-Inf) of SHP643 in Plasma | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post-dose | AUC(0-infinity) of SHP643 in plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported. |
| Maximum Observed Plasma Drug Concentration (Cmax) of SHP643 in Plasma | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post-dose | Cmax is the maximum observed plasma concentration of SHP643 in Plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported. |
| Minimum Time to Reach (Tmax) in Maximum Observed Plasma Drug Concentration of SHP643 in Plasma | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post-dose | Tmax of of SHP643 in plasma was reported. |
| Terminal Half-Life (T1/2) of SHP643 in Plasma | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post-dose | t1/2 of of SHP643 in plasma was reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Developed Positive Antidrug Antibodies to SHP643 at Specified Time Points | Day 1, 14, 28, 56 and 112 (End of Study/Early Termination [EOS/ET]) | Plasma samples were analyzed for presence of antidrug antibodies to SHP643. Participants who developed positive results for SHP643 antibodies were reported. |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From start of study drug administration up to Day 112 (End of Study/Early Termination [EOS/ET]) | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the investigational product (IP) or medicinal product. A treatment-emergent AE (TEAE) was defined as any event emerging or manifesting at or after the initiation of treatment with an IP or medicinal product or any existing event that worsened in either intensity or frequency following exposure to the IP or medicinal product. |
Countries
United States
Participant flow
Recruitment details
This study was conducted at a single site in United States of America from 14 May 2019 (first participant first visit) to 13 November 2019 (last participant last visit).
Pre-assignment details
A total of 190 participants were enrolled and received the treatment. Out of which, 173 participants completed this study.
Participants by arm
| Arm | Count |
|---|---|
| SHP643 Prefilled Syringe (PFS) Participants received 300 milligram (mg) of SHP643 PFS Subcutaneous (SC) injection into the abdomen on Day 1 during the in-house treatment period (Day 1 to Day 5). | 94 |
| SHP643 Autoinjector (AI) Participants received 300 mg of SHP643 AI SC injection into the abdomen on Day 1 during the in-house treatment period (Day 1 to Day 5). | 96 |
| Total | 190 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 1 |
| Overall Study | positive urine drug screening results | 4 | 1 |
| Overall Study | Pregnancy | 0 | 2 |
| Overall Study | Withdrawal by Subject | 3 | 3 |
Baseline characteristics
| Characteristic | SHP643 Autoinjector (AI) | Total | SHP643 Prefilled Syringe (PFS) |
|---|---|---|---|
| Age, Continuous | 42.1 Years STANDARD_DEVIATION 9.67 | 40.8 Years STANDARD_DEVIATION 9.91 | 39.6 Years STANDARD_DEVIATION 10.04 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 92 Participants | 183 Participants | 91 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 7 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 32 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 77 Participants | 158 Participants | 81 Participants |
| Sex: Female, Male Female | 55 Participants | 96 Participants | 41 Participants |
| Sex: Female, Male Male | 41 Participants | 94 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 94 | 0 / 96 |
| other Total, other adverse events | 0 / 94 | 9 / 96 |
| serious Total, serious adverse events | 2 / 94 | 2 / 96 |
Outcome results
Primary
Apparent Total Body Clearance for Extravascular Administration Divided by the Fraction of Dose Absorbed (CL/F) of SHP643 in Plasma
CL/F of of SHP643 in plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
Time frame: Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post-dose
Population: PK set was defined as all randomized participants who received the complete dose of SHP643 and had sufficient data to calculate at least one primary PK endpoint. Here, the number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| SHP643 Prefilled Syringe (PFS) | Apparent Total Body Clearance for Extravascular Administration Divided by the Fraction of Dose Absorbed (CL/F) of SHP643 in Plasma | 0.8511 liter per day (L/day) | Geometric Coefficient of Variation 32.9 |
| SHP643 Autoinjector (AI) | Apparent Total Body Clearance for Extravascular Administration Divided by the Fraction of Dose Absorbed (CL/F) of SHP643 in Plasma | 0.7888 liter per day (L/day) | Geometric Coefficient of Variation 40.8 |
Primary
Apparent Volume of Distribution Associated With the Terminal Slope Following Extravascular Administration Divided by the Fraction of Dose Absorbed (Vdz/F) of SHP643 in Plasma
Vdz/F of SHP643 in plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
Time frame: Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post-dose
Population: PK set was defined as all randomized participants who received the complete dose of SHP643 and had sufficient data to calculate at least one primary PK endpoint. Here, the number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| SHP643 Prefilled Syringe (PFS) | Apparent Volume of Distribution Associated With the Terminal Slope Following Extravascular Administration Divided by the Fraction of Dose Absorbed (Vdz/F) of SHP643 in Plasma | 16.79 Liters (L) | Geometric Coefficient of Variation 31.6 |
| SHP643 Autoinjector (AI) | Apparent Volume of Distribution Associated With the Terminal Slope Following Extravascular Administration Divided by the Fraction of Dose Absorbed (Vdz/F) of SHP643 in Plasma | 15.37 Liters (L) | Geometric Coefficient of Variation 42.7 |
Primary
Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-Inf) of SHP643 in Plasma
AUC(0-infinity) of SHP643 in plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
Time frame: Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post-dose
Population: PK set was defined as all randomized participants who received the complete dose of SHP643 and had sufficient data to calculate at least one primary PK endpoint. Here, the number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| SHP643 Prefilled Syringe (PFS) | Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-Inf) of SHP643 in Plasma | 352.5 day*μg/mL | Geometric Coefficient of Variation 32.9 |
| SHP643 Autoinjector (AI) | Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-Inf) of SHP643 in Plasma | 380.3 day*μg/mL | Geometric Coefficient of Variation 40.8 |
Comparison: An analysis of variance was performed with the natural log-transformed PK parameters as the dependent variable and treatment group as a fixed effect variable.90% CI: [0.987, 1.179]
Primary
Area Under the Concentration Versus Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of SHP643 in Plasma
AUC(0-last) of SHP643 in plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
Time frame: Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post dose
Population: Pharmacokinetic (PK) set was defined as all randomized participants who received the complete dose of SHP643 and had sufficient data to calculate at least one primary PK endpoint. Here, the number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| SHP643 Prefilled Syringe (PFS) | Area Under the Concentration Versus Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of SHP643 in Plasma | 348.9 day*microgram per milliliter (day*ug/mL) | Geometric Coefficient of Variation 33.4 |
| SHP643 Autoinjector (AI) | Area Under the Concentration Versus Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of SHP643 in Plasma | 376.5 day*microgram per milliliter (day*ug/mL) | Geometric Coefficient of Variation 41.3 |
Comparison: An analysis of variance was performed with the natural log-transformed PK parameters as the dependent variable and treatment group as a fixed effect variable.90% CI: [0.986, 1.181]ANOVA
Primary
Maximum Observed Plasma Drug Concentration (Cmax) of SHP643 in Plasma
Cmax is the maximum observed plasma concentration of SHP643 in Plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
Time frame: Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post-dose
Population: PK set was defined as all randomized participants who received the complete dose of SHP643 and had sufficient data to calculate at least one primary PK endpoint. Here, the number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| SHP643 Prefilled Syringe (PFS) | Maximum Observed Plasma Drug Concentration (Cmax) of SHP643 in Plasma | 15.86 microgram per milliliter (ug/mL) | Geometric Coefficient of Variation 40.6 |
| SHP643 Autoinjector (AI) | Maximum Observed Plasma Drug Concentration (Cmax) of SHP643 in Plasma | 18.35 microgram per milliliter (ug/mL) | Geometric Coefficient of Variation 48 |
Comparison: An analysis of variance was performed with the natural log-transformed PK parameters as the dependent variable and treatment group as a fixed effect variable.90% CI: [1.044, 1.281]
Primary
Minimum Time to Reach (Tmax) in Maximum Observed Plasma Drug Concentration of SHP643 in Plasma
Tmax of of SHP643 in plasma was reported.
Time frame: Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post-dose
Population: PPK set was defined as all randomized participants who received the complete dose of SHP643 and had sufficient data to calculate at least one primary PK endpoint. Here, the number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SHP643 Prefilled Syringe (PFS) | Minimum Time to Reach (Tmax) in Maximum Observed Plasma Drug Concentration of SHP643 in Plasma | 4.00 day |
| SHP643 Autoinjector (AI) | Minimum Time to Reach (Tmax) in Maximum Observed Plasma Drug Concentration of SHP643 in Plasma | 4.00 day |
Primary
Terminal Elimination Rate Constant (Lambda z) of SHP643 in Plasma
Lambda z of SHP643 in Plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
Time frame: Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post-dose
Population: PK set was defined as all randomized participants who received the complete dose of SHP643 and had sufficient data to calculate at least one primary PK endpoint. Here, the number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| SHP643 Prefilled Syringe (PFS) | Terminal Elimination Rate Constant (Lambda z) of SHP643 in Plasma | 0.05070 one per day (1/day) | Geometric Coefficient of Variation 15.1 |
| SHP643 Autoinjector (AI) | Terminal Elimination Rate Constant (Lambda z) of SHP643 in Plasma | 0.05132 one per day (1/day) | Geometric Coefficient of Variation 22.1 |
Primary
Terminal Half-Life (T1/2) of SHP643 in Plasma
t1/2 of of SHP643 in plasma was reported.
Time frame: Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post-dose
Population: PK set was defined as all randomized participants who received the complete dose of SHP643 and had sufficient data to calculate at least one primary PK endpoint. Here, the number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SHP643 Prefilled Syringe (PFS) | Terminal Half-Life (T1/2) of SHP643 in Plasma | 13.76 day |
| SHP643 Autoinjector (AI) | Terminal Half-Life (T1/2) of SHP643 in Plasma | 13.20 day |
Secondary
Number of Participants Who Developed Positive Antidrug Antibodies to SHP643 at Specified Time Points
Plasma samples were analyzed for presence of antidrug antibodies to SHP643. Participants who developed positive results for SHP643 antibodies were reported.
Time frame: Day 1, 14, 28, 56 and 112 (End of Study/Early Termination [EOS/ET])
Population: Safety analysis set consisted of all randomized participants who received the dose of SHP643.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SHP643 Prefilled Syringe (PFS) | Number of Participants Who Developed Positive Antidrug Antibodies to SHP643 at Specified Time Points | Participants with positive ADA: Day 14 | 0 Participants |
| SHP643 Prefilled Syringe (PFS) | Number of Participants Who Developed Positive Antidrug Antibodies to SHP643 at Specified Time Points | Participants with positive ADA: Day 56 | 0 Participants |
| SHP643 Prefilled Syringe (PFS) | Number of Participants Who Developed Positive Antidrug Antibodies to SHP643 at Specified Time Points | Participants with positive ADA: Day 28 | 1 Participants |
| SHP643 Prefilled Syringe (PFS) | Number of Participants Who Developed Positive Antidrug Antibodies to SHP643 at Specified Time Points | Participants with positive ADA: Day 112 (EOS/ET) | 0 Participants |
| SHP643 Prefilled Syringe (PFS) | Number of Participants Who Developed Positive Antidrug Antibodies to SHP643 at Specified Time Points | Participants with positive ADA: Day 1 | 1 Participants |
| SHP643 Autoinjector (AI) | Number of Participants Who Developed Positive Antidrug Antibodies to SHP643 at Specified Time Points | Participants with positive ADA: Day 112 (EOS/ET) | 1 Participants |
| SHP643 Autoinjector (AI) | Number of Participants Who Developed Positive Antidrug Antibodies to SHP643 at Specified Time Points | Participants with positive ADA: Day 1 | 0 Participants |
| SHP643 Autoinjector (AI) | Number of Participants Who Developed Positive Antidrug Antibodies to SHP643 at Specified Time Points | Participants with positive ADA: Day 14 | 0 Participants |
| SHP643 Autoinjector (AI) | Number of Participants Who Developed Positive Antidrug Antibodies to SHP643 at Specified Time Points | Participants with positive ADA: Day 28 | 0 Participants |
| SHP643 Autoinjector (AI) | Number of Participants Who Developed Positive Antidrug Antibodies to SHP643 at Specified Time Points | Participants with positive ADA: Day 56 | 1 Participants |
Secondary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the investigational product (IP) or medicinal product. A treatment-emergent AE (TEAE) was defined as any event emerging or manifesting at or after the initiation of treatment with an IP or medicinal product or any existing event that worsened in either intensity or frequency following exposure to the IP or medicinal product.
Time frame: From start of study drug administration up to Day 112 (End of Study/Early Termination [EOS/ET])
Population: Safety analysis set consisted of all randomized participants who received the dose of SHP643.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SHP643 Prefilled Syringe (PFS) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 19 Participants |
| SHP643 Autoinjector (AI) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 30 Participants |