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| Name | Class |
|---|---|
| MonitorCRO | INDUSTRY |
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The purpose of this first in human study is to evaluate the safety and tolerability of RPH-104 in humans.
RPH-104 is a macromolecular compound with a molecular weight of 152.715 kilodalton (Data on file) and is capable of binding human interleukin-1 beta (IL-1β). It has also been shown in vitro to be a highly potent inhibitor of IL-1β signalling pathway, with low picomolar inhibitor activity. In this First in Human study, RPH-104 will be evaluated primarily for its safety and tolerability. In a phase I study conducted with health volunteers, a similar monoclonal antibody, canakinumab, was investigated in terms of pharmacokinetics and pharmacodynamics besides efficacy and safety. Similarly, this aimed to investigate effects of RPH-104 on selected pharmacodynamic parameters, including Anti-Drug Antibodies (ADA) along with obtaining first human data on pharmacokinetics of RPH-104 in humans will be investigated in the same study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Active Comparator | A single dose of RPH-104 (4, 20, 40, 80 or 160 mg) will be administered subcutaneously. |
|
| Placebo | Placebo Comparator | A single 0.9% sodium chloride injection will be administered subcutaneously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RPH-104 | Biological | Anti-IL-1 Mab |
| |
| Sodium chloride Sterile Injection 0.9% w/v |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Number of participants with study drug related adverse events | Until 60 days after administration |
| Serious Adverse Events | Number of Participants with Study Drug Related Serious Adverse Events | Until 60 days after administration |
| Respiratory Rate | Percentage of participants with abnormal respiratory rate. The normal respiration rate for an adult at rest is 12 to 20 breaths per minute. | Until 30 days after administration |
| Blood Pressure | Percentage of participants with abnormal blood pressure. An optimal blood pressure level is a reading under 120/80 mmHg | Until 30 days after administration |
| Oxygen Saturation | Percentage of participants with abnormal oxygen saturation. Normal pulse oximeter readings usually range from 95 to 100 percent. Values under 90 percent are considered low. | Until 30 days after administration |
| Body Temperature | Percentage of participants with abnormal body temperature. Among adults, the average body temperature ranges from 97°F (36.1°C) to 99°F (37.2°C). | Until 30 days after administration |
| Clinical Laboratory Tests | Percentage of participants with abnormal clinical laboratory tests. Normal laboratory ranges of the central laboratory were used. |
| Measure | Description | Time Frame |
|---|---|---|
| RPH-104 - Area Under the Curve (AUC) | Mean AUC 0-t (area under the concentration- time curve from time zero to day 30) | Day 1, Day 2, Day3, Day 4, Day 5, Day 6, Day 9, Day 12, Day 15, Day 20, Day 25, Day 30 |
| RPH-104 - Time to Maximum Concentration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sibel Goksel, MD, PhD | ARGEFAR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ARGEFAR | Izmir | Turkey (Türkiye) |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | A single dose of RPH-104 (4, 20, 40, 80 or 160 mg) is administered subcutaneously. RPH-104 |
| FG001 | Placebo | A single 0.9% sodium chloride injection is administered subcutaneously. Sodium chloride Sterile Injection 0.9% w/v |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All subjects receiving the study medication will be included into the safety evaluation. Subjects who completed the study according to the protocol (per protocol population) will be included into the statistical evaluation. Subject data of drop-out volunteers or volunteers who were not eligible for the study will not be included into statistics.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | A single dose of RPH-104 (4, 20, 40, 80 or 160 mg) is administered subcutaneously. RPH-104 |
| BG001 | Placebo | A single 0.9% sodium chloride injection is administered subcutaneously. Sodium chloride Sterile Injection 0.9% w/v |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Physical examination, ID check and data entry to study specific Case Report Form. |
| 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 | Adverse Events | Number of participants with study drug related adverse events | Posted | Number | participants | Until 60 days after administration |
|
|
60 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 | Treatment | A single dose of RPH-104 (4, 20, 40, 80 or 160 mg) is administered subcutaneously. RPH-104 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal disorders | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Murat Özdemir | Monitor CRO | 902122341260 | murato@monitorcro.com |
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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 | Jul 12, 2018 | Dec 4, 2018 | Prot_SAP_000.pdf |
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| Other |
Sterile saline solution |
|
| Until 30 days after administration |
Median Tmax. Definition of Tmax is time at which Cmax occurs. |
| Day 1, Day 2, Day3, Day 4, Day 5, Day 6, Day 9, Day 12, Day 15, Day 20, Day 25, Day 30 |
| RPH-104 - Elimination Half-life (t1/2) | Mean t½. Definition of t½ is terminal elimination half-life. | Day 1, Day 2, Day3, Day 4, Day 5, Day 6, Day 9, Day 12, Day 15, Day 20, Day 25, Day 30 |
| RPH-104 - Maximum Plasma Concentration (Cmax) | Mean Cmax. Highest concentration determined in the measuring interval. | Day 1, Day 2, Day3, Day 4, Day 5, Day 6, Day 9, Day 12, Day 15, Day 20, Day 25, Day 30 |
| BG002 | Total | Total of all reporting groups |
| Number |
| participants |
|
| Sex: Female, Male | Physical examination and data entry to study specific Case Report Form. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Data entry to study specific Case Report Form. | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Serious Adverse Events | Number of Participants with Study Drug Related Serious Adverse Events | Posted | Count of Participants | Participants | Until 60 days after administration |
|
|
|
| Primary | Respiratory Rate | Percentage of participants with abnormal respiratory rate. The normal respiration rate for an adult at rest is 12 to 20 breaths per minute. | Posted | Number | percentage of participants | Until 30 days after administration |
|
|
|
| Primary | Blood Pressure | Percentage of participants with abnormal blood pressure. An optimal blood pressure level is a reading under 120/80 mmHg | Posted | Number | percentage of participants | Until 30 days after administration |
|
|
|
| Primary | Oxygen Saturation | Percentage of participants with abnormal oxygen saturation. Normal pulse oximeter readings usually range from 95 to 100 percent. Values under 90 percent are considered low. | Posted | Number | percentage of participants | Until 30 days after administration |
|
|
|
| Primary | Body Temperature | Percentage of participants with abnormal body temperature. Among adults, the average body temperature ranges from 97°F (36.1°C) to 99°F (37.2°C). | Posted | Number | percentage of participants | Until 30 days after administration |
|
|
|
| Primary | Clinical Laboratory Tests | Percentage of participants with abnormal clinical laboratory tests. Normal laboratory ranges of the central laboratory were used. | Posted | Number | percentage of participants | Until 30 days after administration |
|
|
|
| Secondary | RPH-104 - Area Under the Curve (AUC) | Mean AUC 0-t (area under the concentration- time curve from time zero to day 30) | Posted | Mean | Standard Deviation | hr*ng/mL | Day 1, Day 2, Day3, Day 4, Day 5, Day 6, Day 9, Day 12, Day 15, Day 20, Day 25, Day 30 |
|
|
|
| Secondary | RPH-104 - Time to Maximum Concentration (Tmax) | Median Tmax. Definition of Tmax is time at which Cmax occurs. | Posted | Median | Full Range | hr | Day 1, Day 2, Day3, Day 4, Day 5, Day 6, Day 9, Day 12, Day 15, Day 20, Day 25, Day 30 |
|
|
|
| Secondary | RPH-104 - Elimination Half-life (t1/2) | Mean t½. Definition of t½ is terminal elimination half-life. | Posted | Mean | Standard Deviation | hr | Day 1, Day 2, Day3, Day 4, Day 5, Day 6, Day 9, Day 12, Day 15, Day 20, Day 25, Day 30 |
|
|
|
| Secondary | RPH-104 - Maximum Plasma Concentration (Cmax) | Mean Cmax. Highest concentration determined in the measuring interval. | Posted | Mean | Standard Deviation | ng/mL | Day 1, Day 2, Day3, Day 4, Day 5, Day 6, Day 9, Day 12, Day 15, Day 20, Day 25, Day 30 |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 22 |
| 25 |
| EG001 | Placebo | A single 0.9% sodium chloride injection is administered subcutaneously. Sodium chloride Sterile Injection 0.9% w/v | 0 | 10 | 0 | 10 | 7 | 10 |
| Nervous system disorders | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Infections and infestations | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| General disorders and administration site conditions | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Investigations | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Ear and labyrinth disorders | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cardiac disorders | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Psychiatric disorders | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Reproductive system and breast disorders | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
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| 40 mg |
|
| 80 mg |
|
| 160 mg |
|
| 40 mg |
|
| 80 mg |
|
| 160 mg |
|
| 40 mg |
|
| 80 mg |
|
| 160 mg |
|
| 40 mg |
|
| 80 mg |
|
| 160 mg |
|