Healthy VolunteerPhase 1NCT04748536
Safety and PK of Repeated Doses of IRL201104 in Healthy Volunteers
A Phase 1 study testing IRL201104 in people with Healthy Volunteer, run by Revolo Biotherapeutics at 1 site in United Kingdom.
Trial summary
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of repeat doses of IRL201104 given to healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- IRL201104
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Jan 2021to 5 Apr 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and female subjects age 18 to 65 years of age, and in good health as determined by medical history, physical examination, vital signs, electrocardiogram, and laboratory tests.
- Female subjects agree to use highly effective contraception or be of non-childbearing potential.
- Written informed consent must be obtained before any assessment is performed.
- Able to communicate well with the Investigator/designee.
Who cannot join
- Any known reaction to study drug or components
- concurrent or recent infection or clinically significant conditions that may place subject at risk or interference with absorption, distribution or excretion of drugs
- No QTcF interval ≥450 milliseconds, no QRS complex ≥120 milliseconds, at Screening
- Positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCVAb) or human immunodeficiency virus (HIV) 1 and/or -2 antibodies at Screening.
- Excessive use of caffeine-containing beverages
- Urinary cotinine level indicative of smoking or history or regular use of tobacco- or nicotine containing products within 6 months before screening.
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- Presence or history of drug of alcohol abuse.
- Positive screen for drugs-of-abuse or cotinine.
- Blood donation in excess of 500mL within 3 months.
- Participation in another clinical study with licensed or unlicensed study drug within 3 months of first IMP administration.
- Exposure to more than 4 new chemical entities within 12 months before the first IMP administration.
- Use of live vaccine 28 days before dosing with study drug until telephone follow-up and use of killed vaccine (including COVID-19 vaccine) 14 days before dosing with study drug until telephone follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Parallel Group Study in Healthy Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of IRL201104 to Support a Future COVID-19 Patient Study
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of repeat doses of IRL201104 given to healthy volunteers.
- Conditions
- Healthy Volunteer
- Being tested
- IRL201104, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRL201104Drug
lyophilised powder for reconstitution for IV dosing
PlaceboDrug
Matching placebo for IRL201104
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Dose A IRL201104 or placebo | Experimental | IRL201104 IV once daily for 5 days OR Placebo IV once daily for 5 days Receives: Drug: IRL201104; Drug: Placebo |
| Group 2: Dose B IRL201104 or placebo | Experimental | IRL201104 IV once daily for 7 days OR Placebo IV once daily for 7 days Receives: Drug: IRL201104; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with TEAEs and number of events will be summarised by treatment
Adverse Events after treatment administration will be collected at baseline and repeated until study completion
Measured: 33 (group 1) or 35 (group 2) days
Number of subjects with potentially clinically important (PCI) abnormal haematology variables will be summarised by treatment
Haemoglobin, haematocrit, MCV, MCH, MCHC, RBC, WBC and differentials will be collected at baseline and after dose administration and repeated until Day 19 or 21
Measured: 19 (group 1) or 21 (group 2) days
Number of subjects with PCI abnormal clinical chemistry variables will be summarised by treatment
Creatinine, glucose, triglycerides, urea, uric acid, bilirubin, cholesterol, sodium, potassium, alkaline phosphatase, AST, ALT and GGT will be collected at baseline and after dose administration and repeated until Day 19 or 21
Measured: 19 (group 1) or 21 (group 2) days
Number of subjects with PCI and/or abnormal electrocardiogram variables will be summarised by treatment
RR, PR, QRS, QT-interval, QTcF and heart rate will be collected at baseline and after dose administration and repeated until Day 19 or 21.
Measured: 19 (group 1) or 21 (group 2) days
Number of subjects with PCI abnormal vital sign variables will be summarised by treatment
Blood pressure, pulse rate, oral body temperature and respiration rate will be collected at baseline and after single and multiple dose administration and repeated until Day 19 or 21
Measured: 19 (group 1) or 21 (group 2) days
Secondary outcomes (6)
Pharmacokinetics of IRL201104: Trough blood concentration (Ctrough)
Ctrough will be measured after multiple dosing
Measured: 5 (group 1) or 7 (group 2) days
PK of IRL201104: Maximum (peak) blood concentration (Cmax)
Cmax will be calculated after multiple dosing
Measured: 5 (group 1) or 7 (group 2) days
PK of IRL201104: Terminal half life (t1/2)
t1/2 will be calculated after multiple dosing
Measured: 5 (group 1) or 7 (group 2) days
PK of IRL201104: Area under the curve from time zero to last quantifiable concentration of IRL201104 (AUCt)
AUCt will be calculated after multiple dosing
Measured: 5 (group 1) or 7 (group 2) days
PK of IRL201104: Apparent total body clearance from blood (CLss)
CLss will be calculated after multiple dosing
Measured: 5 (group 1) or 7 (group 2) days
PK of IRL201104: steady state volume of distribution (Vz)
Vz will be calculated after multiple dosing
Measured: 5 (group 1) or 7 (group 2) days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start29 Jan 2021
- Primary completion5 Apr 2021
- Study completion5 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revolo Biotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04748536
- Sponsor's protocol ID
- C1104-003
- Status last verified
- Feb 2021
- First submitted
- 1 Feb 2021
- Last updated
- 26 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Parallel Group Study in Healthy Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of IRL201104 to Support a Future COVID-19 Patient Study
- ClinicalTrials.gov ID
- NCT04748536
- Acronym / sponsor ID
- C1104-003
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Revolo BiotherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 2021 (actual)
- Primary completion
- 5 Apr 2021 (actual)
- Study completion
- 5 Apr 2021 (actual)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
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 study is to assess the safety, tolerability and pharmacokinetics of repeat doses of IRL201104 given to healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Dose A IRL201104 or placebo | Experimental | Drug: IRL201104, Drug: PlaceboIRL201104 IV once daily for 5 days OR Placebo IV once daily for 5 days |
| Group 2: Dose B IRL201104 or placebo | Experimental | Drug: IRL201104, Drug: PlaceboIRL201104 IV once daily for 7 days OR Placebo IV once daily for 7 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy male and female subjects age 18 to 65 years of age, and in good health as determined by medical history, physical examination, vital signs, electrocardiogram, and laboratory tests.
- Female subjects agree to use highly effective contraception or be of non-childbearing potential.
- Written informed consent must be obtained before any assessment is performed.
- Able to communicate well with the Investigator/designee.
Key exclusion criteria (12 listed)
- Any known reaction to study drug or components
- concurrent or recent infection or clinically significant conditions that may place subject at risk or interference with absorption, distribution or excretion of drugs
- No QTcF interval ≥450 milliseconds, no QRS complex ≥120 milliseconds, at Screening
- Positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCVAb) or human immunodeficiency virus (HIV) 1 and/or -2 antibodies at Screening.
- Excessive use of caffeine-containing beverages
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 |
|---|---|---|
| IRL201104lyophilised powder for reconstitution for IV dosing | Drug | Group 1: Dose A IRL201104 or placebo, Group 2: Dose B IRL201104 or placebo |
| PlaceboMatching placebo for IRL201104 | Drug | Group 1: Dose A IRL201104 or placebo, Group 2: Dose B IRL201104 or placebo |
Primary outcome
Number of subjects with TEAEs and number of events will be summarised by treatment
Time frame: 33 (group 1) or 35 (group 2) days
Adverse Events after treatment administration will be collected at baseline and repeated until study completion
Number of subjects with potentially clinically important (PCI) abnormal haematology variables will be summarised by treatment
Time frame: 19 (group 1) or 21 (group 2) days
Haemoglobin, haematocrit, MCV, MCH, MCHC, RBC, WBC and differentials will be collected at baseline and after dose administration and repeated until Day 19 or 21
Number of subjects with PCI abnormal clinical chemistry variables will be summarised by treatment
Time frame: 19 (group 1) or 21 (group 2) days
Creatinine, glucose, triglycerides, urea, uric acid, bilirubin, cholesterol, sodium, potassium, alkaline phosphatase, AST, ALT and GGT will be collected at baseline and after dose administration and repeated until Day 19 or 21
Number of subjects with PCI and/or abnormal electrocardiogram variables will be summarised by treatment
Time frame: 19 (group 1) or 21 (group 2) days
RR, PR, QRS, QT-interval, QTcF and heart rate will be collected at baseline and after dose administration and repeated until Day 19 or 21.
Number of subjects with PCI abnormal vital sign variables will be summarised by treatment
Time frame: 19 (group 1) or 21 (group 2) days
Blood pressure, pulse rate, oral body temperature and respiration rate will be collected at baseline and after single and multiple dose administration and repeated until Day 19 or 21
6 secondary outcomes
Pharmacokinetics of IRL201104: Trough blood concentration (Ctrough)
Time frame: 5 (group 1) or 7 (group 2) days
PK of IRL201104: Maximum (peak) blood concentration (Cmax)
Time frame: 5 (group 1) or 7 (group 2) days
PK of IRL201104: Terminal half life (t1/2)
Time frame: 5 (group 1) or 7 (group 2) days
PK of IRL201104: Area under the curve from time zero to last quantifiable concentration of IRL201104 (AUCt)
Time frame: 5 (group 1) or 7 (group 2) days
PK of IRL201104: Apparent total body clearance from blood (CLss)
Time frame: 5 (group 1) or 7 (group 2) days
PK of IRL201104: steady state volume of distribution (Vz)
Time frame: 5 (group 1) or 7 (group 2) days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 IRL201104 in people with Healthy Volunteer, run by Revolo Biotherapeutics at 1 site in United Kingdom.
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 4 inclusion and 12 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 26 Apr 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 United Kingdom. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of subjects with TEAEs and number of events will be summarised by treatment (time frame: 33 (group 1) or 35 (group 2) days). The study lists 5 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 26 Apr 2021.