HealthyPhase 1NCT05288660
A Study of a Single Dose of ALXN1210 in Healthy Participants
A Phase 1 study testing ALXN1210 in people with Healthy, run by Alexion Pharmaceuticals, Inc. at 1 site in Canada.
Trial summary
This study evaluated the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a single dose of ALXN1210 in healthy participants, as assessed by electrocardiograms, physical examination, vital signs, laboratory analysis, and assessment of adverse events (AEs). Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ALXN1210
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- 27 Aug 2014to 13 Mar 2015
- 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index from 18 through 29.9 kilogram (kg)/square meter, inclusive, and weight between 50 and 100 kg, inclusive.
- QT interval (Fridericia's correction); ≤450 milliseconds (msec) for males and ≤470 msec for females at screening and pre-dose on Day 1.
- Willing and able to give written informed consent and comply with the study visit schedule.
- Male participant and his female spouse/partner who was of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control (at least 1 of which must be a barrier method), starting at screening and continuing until at least 5 months after the last dose of ALXN1210.
- Documented vaccination with meningococcal conjugate vaccine (MCV4) at least 14 days and not more than 3 years prior to dosing.
Who cannot join
- Participants in intimate and prolonged contact (defined as living under the same roof or providing personal care) with individuals who are either immunocompromised, or with a specific underlying medical conditions (anatomic or functional asplenia [including sickle cell disease]; congenital complement, properdin, factor D, or primary antibody deficiencies; acquired complement deficiencies [for example, those receiving eculizumab]; and human immunodeficiency virus [HIV]), people younger than 2 years old and older than 65 years old, and professionals exposed to environments of greater risk for meningococcal disease (research, industrial, and clinical laboratory personnel who are routinely exposed to Neisseria meningitidis, military personnel during recruit training [military personnel may be at increased risk when accommodated in close quarters], daycare center workers, or those living on a college or university campus).
- Participants living or working in the Saguenay-Lac-St-Jean area (due to increased incidence of meningococcal infections in that specific area).
- Female participants of childbearing potential, including any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), or who was pregnant, breastfeeding, or was not postmenopausal.
- Positive serum pregnancy test at screening or Day -1.
- Serum creatinine greater than the upper limit of normal (ULN) of the testing laboratory at screening and Day -1.
- Alanine aminotransferase or aspartate aminotransferase >ULN of the testing laboratory at screening and Day -1.
Show all 26Show fewer
- Any of the following hematology tests: hemoglobin <135 grams (g)/L for males and <120 g/L for females; hematocrit <0.41 L/L for males and <0.36 L/L for females; white blood cells <3.5*10^3/microliter (μL) or >ULN of the testing laboratory; absolute neutrophils <1.5*10^3/μL (<1.0*10^3/μL for black race volunteers) or >ULN of the testing laboratory; and platelets <the lower limit of normal of the testing laboratory or >450*10^3/μL at screening and Day -1.
- HIV infection (evidenced by HIV-1 or HIV-2 antibody titer).
- Acute or chronic hepatitis B virus (HBV) infection (evidenced by the presence of HBV surface antigen or immunoglobulin M antibodies against HBV core antigen).
- Acute or chronic hepatitis C virus infection (evidenced by antibody titer).
- Active systemic bacterial, viral, or fungal infection within 14 days prior to dosing.
- Positive QuantiFERON-TB test, indicating possible tuberculosis (TB) infection.
- History of complement deficiency.
- History of malignancy other than basal cell carcinoma.
- Participated in a clinical trial within 30 days before initiation of dosing on Day 1, or used any experimental small-molecule therapy within 30 days prior to dosing on Day 1, or biologic therapy within 90 days prior to initiation of dosing on Day 1 or within 5 half-lives of the product, whichever is greater.
- Major surgery within the last 90 days prior to dosing.
- History of any Neisseria infection; history of unexplained, recurrent infection; or infection requiring treatment with systemic antibiotics within the last 90 days prior to dosing.
- Contraindication to receiving MCV4, including severe (life-threatening) allergic reaction to a previous dose of MCV4; severe (life-threatening) allergy to any vaccine component; previous diagnosis of Guillain-Barré Syndrome.
- History of allergy to excipients of ALXN1210 (that is, polysorbate 80)
- History of allergy to penicillin or cephalosporin, or history of significant allergic reaction to other products (anaphylaxis and angioedema).
- Positive urine drug toxicology screen.
- Donation of plasma within 7 days prior to dosing. Donation or loss of blood of more than 50 mL of blood within 30 days of dosing, or more than 499 mL of blood within 56 days of dosing.
- Clinical diagnosis of any autoimmune or rheumatologic disease (for example, systemic lupus erythematosus, and rheumatoid arthritis) or other condition or medical history that, in the opinion of the Investigator, might interfere with the participant's participation in the study, poses an added risk for the participant, or confounds the assessment of the participant or outcome of the study.
- History of latent or active TB or exposure to endemic areas within 8 weeks prior to the TB test performed at screening.
- Immunization with a live attenuated vaccine 1 month prior to dosing or planned vaccination during the course of the study (except for the vaccination planned by the study protocol).
- Presence of fever (body temperature > 37.6°C) (for example, a fever associated with a symptomatic viral or bacterial infection) within 2 weeks prior to the first dosing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Blinded, Placebo Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of ALXN1210 Administered Intravenously to Healthy Subjects
This study evaluated the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a single dose of ALXN1210 in healthy participants, as assessed by electrocardiograms, physical examination, vital signs, laboratory analysis, and assessment of adverse events (AEs).
Read the detailed description
The participants were randomized in a 2:1 ratio (4 active and 2 placebo) to receive a single dose of ALXN1210 or placebo in the 200-milligram (mg) dose cohort and in a 3:1 ratio (6 active and 2 placebo) to receive a single dose of ALXN1210 or placebo in the 400-mg dose cohort, administered by intravenous (IV) infusion. A 150-day observation period was performed for safety, pharmacokinetic, and pharmacodynamic assessments after study drug administration. Antidrug antibody (ADA) levels were monitored in study participants for the duration of the 150-day follow-up period.
- Conditions
- Healthy
- Being tested
- ALXN1210, Placebo
- Keywords
- ALXN1210, Pharmacokinetic, Pharmacodynamic, Safety, Immunogenicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALXN1210Drug
Also called Ultomiris, Ravulizumab
All doses of ALXN1210 were administered by IV infusion, using programmable IV infusion pump and IV sets with in-line filters, at a fixed rate of 686 mg/hour (equivalent to 137 milliliters [mL]/hour), excluding interruption for safety or technical reason.
PlaceboDrug
All doses of placebo were administered by IV infusion, using programmable IV infusion pump and IV sets with in-line filters, at a fixed rate of 686 mg/hour (equivalent to 137 mL/hour), excluding interruption for safety or technical reason.
| Study group | Role | What they receive |
|---|---|---|
| ALXN1210 200 mg | Experimental | ALXN1210 was administered intravenously. Receives: Drug: ALXN1210 |
| ALXN1210 400 mg | Experimental | ALXN1210 was administered intravenously. Receives: Drug: ALXN1210 |
| Placebo | Placebo comparator | Placebo was administered intravenously. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAEs were defined as AEs that occurred on or after the date and time of study drug administration, or those that first occurred before dosing but worsened in frequency or severity after study drug administration. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Measured: Baseline up to Day 150
Secondary outcomes (15)
Maximum Observed Serum Concentration (Cmax) of ALXN1210
Blood samples were collected for estimation of Cmax by noncompartmental analyses using Pharsight Knowledgebase Server 4.0.2 and Phoenix WinNonlin 5.3.
Measured: Predose, 30 minutes, 4, 8, 24, 48, 96 hours postdose, then at Days 8, 15, 22, 29, 36, 43, 50, 57, 71, 90, 120 and 150
Time To Maximum Observed Serum Concentration (Tmax) of ALXN1210
Blood samples were collected for estimation of Tmax by noncompartmental analyses using Pharsight Knowledgebase Server 4.0.2 and Phoenix WinNonlin 5.3.
Measured: Predose, 30 minutes, 4, 8, 24, 48, 96 hours postdose, then at Days 8, 15, 22, 29, 36, 43, 50, 57, 71, 90, 120 and 150
Area Under The Serum Concentration Versus Time Curve From Time Zero To The Time of The Last Quantifiable Concentration (AUC0-t) of ALXN1210
Blood samples were collected for estimation of AUC0-t by noncompartmental analyses using Pharsight Knowledgebase Server 4.0.2 and Phoenix WinNonlin 5.3.
Measured: Predose, 30 minutes, 4, 8, 24, 48, 96 hours postdose, then at Days 8, 15, 22, 29, 36, 43, 50, 57, 71, 90, 120 and 150
Area Under The Serum Concentration Versus Time Curve From Time Zero (Dosing) To Infinity (AUCinf) of ALXN1210
Blood samples were collected for estimation of AUCinf by noncompartmental analyses using Pharsight Knowledgebase Server 4.0.2 and Phoenix WinNonlin 5.3.
Measured: Predose, 30 minutes, 4, 8, 24, 48, 96 hours postdose, then at Days 8, 15, 22, 29, 36, 43, 50, 57, 71, 90, 120 and 150
Terminal Elimination Rate Constant (λz) of Serum ALXN1210
Blood samples were collected for estimation of λz by noncompartmental analyses using Pharsight Knowledgebase Server 4.0.2 and Phoenix WinNonlin 5.3.
Measured: Predose, 30 minutes, 4, 8, 24, 48, 96 hours postdose, then at Days 8, 15, 22, 29, 36, 43, 50, 57, 71, 90, 120 and 150
Terminal Elimination Half-life (t½) of Serum ALXN1210
Blood samples were collected for estimation of t½ by noncompartmental analyses using Pharsight Knowledgebase Server 4.0.2 and Phoenix WinNonlin 5.3.
Measured: Predose, 30 minutes, 4, 8, 24, 48, 96 hours postdose, then at Days 8, 15, 22, 29, 36, 43, 50, 57, 71, 90, 120 and 150
Total Clearance (CL) of ALXN1210
Blood samples were collected for estimation of CL by noncompartmental analyses using Pharsight Knowledgebase Server 4.0.2 and Phoenix WinNonlin 5.3.
Measured: Predose, 30 minutes, 4, 8, 24, 48, 96 hours postdose, then at Days 8, 15, 22, 29, 36, 43, 50, 57, 71, 90, 120 and 150
Volume of Distribution (Vd) of ALXN1210
Blood samples were collected for estimation of Vd by noncompartmental analyses using Pharsight Knowledgebase Server 4.0.2 and Phoenix WinNonlin 5.3.
Measured: Predose, 30 minutes, 4, 8, 24, 48, 96 hours postdose, then at Days 8, 15, 22, 29, 36, 43, 50, 57, 71, 90, 120 and 150
Percent Change From Baseline in Free Complement Component 5 (C5)
Blood samples were collected for analysis of free C5 concentrations.
Measured: Baseline, Day 150
Percent Change From Baseline in Total Complement C5
Blood samples were collected for analysis of total C5 concentrations.
Measured: Baseline, Day 150
Percent Change From Baseline in Complement C5b-9
Blood samples were collected for analysis of C5b-9 concentrations.
Measured: Baseline, Day 8
Percent Change From Baseline in Chicken Red Blood Cell Hemolysis
Blood samples were collected for analysis of cRBC hemolysis.
Measured: Baseline, Day 150
Percent Change From Baseline In Complement Classical Pathway (CCP) Activity
Blood samples were collected for analysis of CCP.
Measured: Baseline, Day 150
Percent Change From Baseline In Complement Alternative Pathway (CAP) Activity
Blood samples were collected for analysis of CAP.
Measured: Baseline, Day 150
Percentage of Participants With Positive Anti-Drug Antibody (ADA)
Blood samples were collected to evaluate antibody response through development of ADAs.
Measured: Baseline up to Day 150
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start27 Aug 2014
- Primary completion13 Mar 2015
- Study completion13 Mar 2015
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.
- More trials run by Alexion Pharmaceuticals, Inc.The sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288660
- Sponsor's protocol ID
- ALXN1210-HV-101
- Status last verified
- Jun 2022
- First submitted
- 11 Mar 2022
- Last updated
- 9 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Blinded, Placebo Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of ALXN1210 Administered Intravenously to Healthy Subjects
- ClinicalTrials.gov ID
- NCT05288660
- Acronym / sponsor ID
- ALXN1210-HV-101
- Conditions
- Healthy
- Keywords
- ALXN1210, Pharmacokinetic, Pharmacodynamic, Safety, Immunogenicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Aug 2014 (actual)
- Primary completion
- 13 Mar 2015 (actual)
- Study completion
- 13 Mar 2015 (actual)
- First posted
- 21 Mar 2022 (actual)
- Results
- Posted 9 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluated the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a single dose of ALXN1210 in healthy participants, as assessed by electrocardiograms, physical examination, vital signs, laboratory analysis, and assessment of adverse events (AEs).
Detailed description
The participants were randomized in a 2:1 ratio (4 active and 2 placebo) to receive a single dose of ALXN1210 or placebo in the 200-milligram (mg) dose cohort and in a 3:1 ratio (6 active and 2 placebo) to receive a single dose of ALXN1210 or placebo in the 400-mg dose cohort, administered by intravenous (IV) infusion. A 150-day observation period was performed for safety, pharmacokinetic, and pharmacodynamic assessments after study drug administration. Antidrug antibody (ADA) levels were monitored in study participants for the duration of the 150-day follow-up period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ALXN1210 200 mg | Experimental | Drug: ALXN1210ALXN1210 was administered intravenously. |
| ALXN1210 400 mg | Experimental | Drug: ALXN1210ALXN1210 was administered intravenously. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo was administered intravenously. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Body mass index from 18 through 29.9 kilogram (kg)/square meter, inclusive, and weight between 50 and 100 kg, inclusive.
- QT interval (Fridericia's correction); ≤450 milliseconds (msec) for males and ≤470 msec for females at screening and pre-dose on Day 1.
- Willing and able to give written informed consent and comply with the study visit schedule.
- Male participant and his female spouse/partner who was of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control (at least 1 of which must be a barrier method), starting at screening and continuing until at least 5 months after the last dose of ALXN1210.
- Documented vaccination with meningococcal conjugate vaccine (MCV4) at least 14 days and not more than 3 years prior to dosing.
Key exclusion criteria (26 listed)
- Participants in intimate and prolonged contact (defined as living under the same roof or providing personal care) with individuals who are either immunocompromised, or with a specific underlying medical conditions (anatomic or functional asplenia [including sickle cell disease]; congenital complement, properdin, factor D, or primary antibody deficiencies; acquired complement deficiencies [for example, those receiving eculizumab]; and human immunodeficiency virus [HIV]), people younger than 2 years old and older than 65 years old, and professionals exposed to environments of greater risk for meningococcal disease (research, industrial, and clinical laboratory personnel who are routinely exposed to Neisseria meningitidis, military personnel during recruit training [military personnel may be at increased risk when accommodated in close quarters], daycare center workers, or those living on a college or university campus).
- Participants living or working in the Saguenay-Lac-St-Jean area (due to increased incidence of meningococcal infections in that specific area).
- Female participants of childbearing potential, including any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), or who was pregnant, breastfeeding, or was not postmenopausal.
- Positive serum pregnancy test at screening or Day -1.
- Serum creatinine greater than the upper limit of normal (ULN) of the testing laboratory at screening and Day -1.
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 |
|---|---|---|
| ALXN1210Also: Ultomiris, RavulizumabAll doses of ALXN1210 were administered by IV infusion, using programmable IV infusion pump and IV sets with in-line filters, at a fixed rate of 686 mg/hour (equivalent to 137 milliliters [mL]/hour), excluding interruption for safety or technical reason. | Drug | ALXN1210 200 mg, ALXN1210 400 mg |
| PlaceboAll doses of placebo were administered by IV infusion, using programmable IV infusion pump and IV sets with in-line filters, at a fixed rate of 686 mg/hour (equivalent to 137 mL/hour), excluding interruption for safety or technical reason. | Drug | Placebo |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Baseline up to Day 150
TEAEs were defined as AEs that occurred on or after the date and time of study drug administration, or those that first occurred before dosing but worsened in frequency or severity after study drug administration. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
15 secondary outcomes
Maximum Observed Serum Concentration (Cmax) of ALXN1210
Time frame: Predose, 30 minutes, 4, 8, 24, 48, 96 hours postdose, then at Days 8, 15, 22, 29, 36, 43, 50, 57, 71, 90, 120 and 150
Time To Maximum Observed Serum Concentration (Tmax) of ALXN1210
Time frame: Predose, 30 minutes, 4, 8, 24, 48, 96 hours postdose, then at Days 8, 15, 22, 29, 36, 43, 50, 57, 71, 90, 120 and 150
Area Under The Serum Concentration Versus Time Curve From Time Zero To The Time of The Last Quantifiable Concentration (AUC0-t) of ALXN1210
Time frame: Predose, 30 minutes, 4, 8, 24, 48, 96 hours postdose, then at Days 8, 15, 22, 29, 36, 43, 50, 57, 71, 90, 120 and 150
Area Under The Serum Concentration Versus Time Curve From Time Zero (Dosing) To Infinity (AUCinf) of ALXN1210
Time frame: Predose, 30 minutes, 4, 8, 24, 48, 96 hours postdose, then at Days 8, 15, 22, 29, 36, 43, 50, 57, 71, 90, 120 and 150
Terminal Elimination Rate Constant (λz) of Serum ALXN1210
Time frame: Predose, 30 minutes, 4, 8, 24, 48, 96 hours postdose, then at Days 8, 15, 22, 29, 36, 43, 50, 57, 71, 90, 120 and 150
Terminal Elimination Half-life (t½) of Serum ALXN1210
Time frame: Predose, 30 minutes, 4, 8, 24, 48, 96 hours postdose, then at Days 8, 15, 22, 29, 36, 43, 50, 57, 71, 90, 120 and 150
Total Clearance (CL) of ALXN1210
Time frame: Predose, 30 minutes, 4, 8, 24, 48, 96 hours postdose, then at Days 8, 15, 22, 29, 36, 43, 50, 57, 71, 90, 120 and 150
Volume of Distribution (Vd) of ALXN1210
Time frame: Predose, 30 minutes, 4, 8, 24, 48, 96 hours postdose, then at Days 8, 15, 22, 29, 36, 43, 50, 57, 71, 90, 120 and 150
Percent Change From Baseline in Free Complement Component 5 (C5)
Time frame: Baseline, Day 150
Percent Change From Baseline in Total Complement C5
Time frame: Baseline, Day 150
Percent Change From Baseline in Complement C5b-9
Time frame: Baseline, Day 8
Percent Change From Baseline in Chicken Red Blood Cell Hemolysis
Time frame: Baseline, Day 150
Percent Change From Baseline In Complement Classical Pathway (CCP) Activity
Time frame: Baseline, Day 150
Percent Change From Baseline In Complement Alternative Pathway (CAP) Activity
Time frame: Baseline, Day 150
Percentage of Participants With Positive Anti-Drug Antibody (ADA)
Time frame: Baseline up to Day 150
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.
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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 ALXN1210 in people with Healthy, run by Alexion Pharmaceuticals, Inc. at 1 site in Canada.
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 5 inclusion and 26 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 9 May 2023. 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 Canada. 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 9 May 2023). 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?
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (time frame: Baseline up to Day 150). 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 9 May 2023.