HealthyPhase 1NCT02667639
Pharmacokinetics and Pharmacodynamics of RPH-104 in Healthy Subjects
A Phase 1 study testing RPH-104 and Sodium chloride Sterile Injection 0.9% w/v in people with Healthy, run by R-Pharm at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this first in human study is to evaluate the safety and tolerability of RPH-104 in humans. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- RPH-104 and Sodium chloride Sterile Injection 0.9% w/v
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2016to Jun 2017
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects.
- Male or female subjects between 18 and 35 years old (inclusive).
- Subject who has normal body weight as determined by a body mass index (BMI) of between 18 kg/m² and 30 kg/m² (inclusive) and within a body weight of ≥50kg and ≤120kg.
Who cannot join
- Subject who has a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, dermatological, neurological, psychiatric, and hematological or immunological disorder(s), and/or any condition that could constitute a potential safety risk factor or could alter the absorption, distribution, metabolism or elimination of the study drugs.
- Subject who has positive immunoglobulin-M (IgM) antibodies against Epstein-Barr virus (EBV)-viral capsid antigen (VCA) (IgM-anti-EBV-VCA) and Cytomegalovirus (CMV).
- Subject who has a positive Quantiferon TB-Gold (TB) test
- Subject who is positive to Human Immunodeficiency Virus-1/2 antibody (HIV-1/2Ab).
- Subject who has serum hepatitis, or is a carrier of the Hepatitis B surface antigen (HBsAg), or is Hepatitis C virus antibody (HCV-Ab) positive.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single-center, Phase I, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RPH-104 in Healthy Subjects
The purpose of this first in human study is to evaluate the safety and tolerability of RPH-104 in humans.
Read the detailed description
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.
- Conditions
- Healthy
- Being tested
- RPH-104, Sodium chloride Sterile Injection 0.9% w/v
- Keywords
- safety, tolerability, RPH-104, RPH104, Anti-IL1 beta, Anti-IL1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RPH-104Biological
Anti-IL-1 Mab
Sodium chloride Sterile Injection 0.9% w/vOther
Sterile saline solution
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | A single dose of RPH-104 (4, 20, 40, 80 or 160 mg) will be administered subcutaneously. Receives: Biological: RPH-104 |
| Placebo | Placebo comparator | A single 0.9% sodium chloride injection will be administered subcutaneously. Receives: Other: Sodium chloride Sterile Injection 0.9% w/v |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Number of participants with study drug related adverse events
Measured: Until 60 days after administration
Serious Adverse Events
Number of Participants with Study Drug Related Serious Adverse Events
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Until 30 days after administration
Secondary outcomes (4)
RPH-104 - Area Under the Curve (AUC)
Mean AUC 0-t (area under the concentration- time curve from time zero to day 30)
Measured: 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)
Median Tmax. Definition of Tmax is time at which Cmax occurs.
Measured: 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.
Measured: 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.
Measured: Day 1, Day 2, Day3, Day 4, Day 5, Day 6, Day 9, Day 12, Day 15, Day 20, Day 25, Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- R-Pharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MonitorCRO
- Responsible party
- Sponsor
- Investigators
- Sibel Goksel, MD, PhD, Principal investigator, ARGEFAR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02667639
- Sponsor's protocol ID
- RPH104FIH01
- Status last verified
- Sep 2019
- First submitted
- 20 Jan 2016
- Last updated
- 28 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single-center, Phase I, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RPH-104 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02667639
- Acronym / sponsor ID
- RPH104FIH01
- Conditions
- Healthy
- Keywords
- safety, tolerability, RPH-104, RPH104, Anti-IL1 beta, Anti-IL1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- R-PharmIndustry (pharma, biotech, devices)
- Collaborators
- MonitorCRO
- Study start
- Jan 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 29 Jan 2016 (estimated)
- Results
- Posted 4 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this first in human study is to evaluate the safety and tolerability of RPH-104 in humans.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Biological: RPH-104A single dose of RPH-104 (4, 20, 40, 80 or 160 mg) will be administered subcutaneously. |
| Placebo | Placebo comparator | Other: Sodium chloride Sterile Injection 0.9% w/vA single 0.9% sodium chloride injection will be administered subcutaneously. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy subjects.
- Male or female subjects between 18 and 35 years old (inclusive).
- Subject who has normal body weight as determined by a body mass index (BMI) of between 18 kg/m² and 30 kg/m² (inclusive) and within a body weight of ≥50kg and ≤120kg.
Key exclusion criteria (5 listed)
- Subject who has a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, dermatological, neurological, psychiatric, and hematological or immunological disorder(s), and/or any condition that could constitute a potential safety risk factor or could alter the absorption, distribution, metabolism or elimination of the study drugs.
- Subject who has positive immunoglobulin-M (IgM) antibodies against Epstein-Barr virus (EBV)-viral capsid antigen (VCA) (IgM-anti-EBV-VCA) and Cytomegalovirus (CMV).
- Subject who has a positive Quantiferon TB-Gold (TB) test
- Subject who is positive to Human Immunodeficiency Virus-1/2 antibody (HIV-1/2Ab).
- Subject who has serum hepatitis, or is a carrier of the Hepatitis B surface antigen (HBsAg), or is Hepatitis C virus antibody (HCV-Ab) positive.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RPH-104Anti-IL-1 Mab | Biological | Treatment |
| Sodium chloride Sterile Injection 0.9% w/vSterile saline solution | Other | Placebo |
Primary outcome
Adverse Events
Time frame: Until 60 days after administration
Number of participants with study drug related adverse events
Serious Adverse Events
Time frame: Until 60 days after administration
Number of Participants with Study Drug Related Serious Adverse Events
Respiratory Rate
Time frame: Until 30 days after administration
Percentage of participants with abnormal respiratory rate. The normal respiration rate for an adult at rest is 12 to 20 breaths per minute.
Blood Pressure
Time frame: Until 30 days after administration
Percentage of participants with abnormal blood pressure. An optimal blood pressure level is a reading under 120/80 mmHg
Oxygen Saturation
Time frame: Until 30 days after administration
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.
Body Temperature
Time frame: Until 30 days after administration
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).
Clinical Laboratory Tests
Time frame: Until 30 days after administration
Percentage of participants with abnormal clinical laboratory tests. Normal laboratory ranges of the central laboratory were used.
4 secondary outcomes
RPH-104 - Area Under the Curve (AUC)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Day 1, Day 2, Day3, Day 4, Day 5, Day 6, Day 9, Day 12, Day 15, Day 20, Day 25, Day 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sibel Goksel, MD, PhD principal investigator
ARGEFAR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RPH-104 and Sodium chloride Sterile Injection 0.9% w/v in people with Healthy, run by R-Pharm at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: Until 60 days after administration). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2021.