Healthy Study ParticipantsPhase 1NCT04828343

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Rozanolixizumab Administered Subcutaneously Via Manual Push Versus Syringe Driver to Healthy Participants

A Phase 1 study testing rozanolixizumab in people with Healthy Study Participants, run by UCB Biopharma SRL at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a single subcutaneous (SC) dose of rozanolixizumab administered to healthy participants by manual push (MP) versus (vs) syringe driver. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Study Participants
What is being tested?: rozanolixizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 32 participants
Where: 1 siteUnited Kingdom
Study dates: 22 Apr 2021to 11 Apr 2022
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Study participant must be 18 to 65 years of age, inclusive
Study participants who are overtly healthy in the opinion of the investigator as determined by medical evaluation including medical history, a general clinical examination, including physical examination and laboratory tests, and cardiac monitoring
Study participant has blood pressure (BP) and pulse within normal range in a supine position after 5 minutes of rest (systolic BP: 90 to 140 mmHg, diastolic BP: 50 to 90 mmHg, pulse: 40 to 90 beats per minute (bpm))
Study participant has clinical laboratory test results within the reference ranges of the testing laboratory or not clinically significant if outside the specified ranges, in the opinion of the investigator
Study participant's electrocardiogram (ECG) is considered "normal" or "abnormal but clinically nonsignificant" (as interpreted by the investigator)
Study participants may be male or female
Participant has a body mass index of 18 to 32 kg/m^2, with a minimum body weight of 35 kg

Who cannot join

History or presence of/significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders. Has active neoplastic disease or history of neoplastic disease within the previous 5 years of entry in the clinical study (except for basal or squamous cell carcinoma of the skin or carcinoma in situ that has been definitively treated with standard of care approaches). Has a history of a major organ transplant or hematopoietic stem cell/marrow transplant
Symptomatic herpes zoster within 3 months prior to Screening
Allergies to humanized monoclonal antibodies
Female who is pregnant or lactating
Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe posttreatment hypersensitivity reactions
Evidence of active or latent tuberculosis (TB) as documented by medical history and examination

Show all 30Show fewer

Predicted inability to comply with being free of caffeine and ethanol from 72 hours prior to clinic admission and during the In-Clinic Period of the study
Known hypersensitivity to oral paracetamol (acetaminophen)
History of known inflammatory bowel disease, active diverticular disease, or a history of confirmed duodenal, gastric, or esophageal ulceration in the previous 6 months
History of hyperprolinemia, since L-proline is a constituent of rozanolixizumab.
Twelve-lead ECG with abnormalities considered to be clinically significant upon medical review
Renal impairment, defined as a creatinine concentration in serum of ≥1.4 mg/dL (≥123 μmol/L) for female participants and ≥1.5 mg/dL (≥132 μmol/L) for male participants
Known viral hepatitis (B and C) or human immunodeficiency virus 1/2 antibodies or has a past medical history or family history of primary immunodeficiency or antibodies to human immunodeficiency virus type 1 and/or type 2 at Screening
Participant has a positive test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in reverse transcriptase-polymerase chain reaction on admission to the unit
Participant has clinical signs and symptoms consistent with SARS-CoV-2 (eg, fever, dry cough, dyspnea, sore throat, fatigue) or confirmed infection by appropriate laboratory test within the previous 14 days prior to Screening or on admission
Participant has active infection or is symptomatic with SARS-CoV-2 or is currently in quarantine (has been in contact with a SARS-CoV-2 positive individual in the last 14 days)
Participant has had a severe course of SARS-CoV-2 (eg, requiring extracorporeal membrane oxygenation, mechanical ventilation, or hospitalization)
Past or intended use of over-the-counter or prescription medication (including herbal medications) within 14 days prior to dosing until Day 57
Live vaccine(s) within 8 weeks prior to Screening or plans to receive such vaccines during the study or is within a dosing cycle to receive a second dose of a coronavirus disease-19 (COVID-19) vaccine, or within 2 weeks of having received a COVID-19 vaccine
Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing
Exposure to more than 3 new chemical entities within 12 months prior to dosing
Has previously been assigned to treatment in a clinical study of rozanolixizumab
Participated in another study of an investigational medicinal product (IMP) (or a medical device) within the previous 90 days or 5 half-lives prior to Day -1 (whichever is longer) or is currently participating in another study of an IMP (or a medical device)
Immunoglobulin G <7g/L or >16g/L at the Screening Visit
Participant is splenectomized or has had an active clinically significant infection within the last 6 weeks
Donated or lost >500 mL of blood or blood products in the 3 months preceding the start of dosing or plans to donate blood during the clinical study
Employee or direct relative of an employee of the contract research organization (CRO) or UCB
History of alcohol and/or drug abuse up to 12 months before Screening
Smoked on average >5 cigarettes/day (or equivalent) during the last 3 months and is not able to stop smoking during the In-Clinic Period
Excessive consumption of beverages or food containing xanthine bases (including caffeinated drinks, coffee, chocolate, etc.), equating to >400 mg caffeine per day

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Up0106 001
London

Other trials in United Kingdom

About this study

Official title: A Randomized, Participant-Blind, Investigator-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Rozanolixizumab Administered Subcutaneously Via Manual Push Versus Syringe Driver to Healthy Participants

Conditions: Healthy Study Participants
Being tested: rozanolixizumab, Placebo
Keywords: Healthy Study Participants, Phase 1, rozanolixizumab, manual push, syringe driver

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

rozanolixizumabDrug
Also called RLZ
Study participants will receive a single dose rozanolixizumab subcutaneously administered by manual push or a syringe driver.
PlaceboOther
Also called PBO
Study participants will receive a single dose placebo subcutaneously administered by manual push or a syringe driver.

Study groups in NCT04828343
Study group	Role	What they receive
Cohort 1 <50 kg	Experimental	Study participants randomized to Cohort 1 will receive a single dose of rozanolixizumab (RLZ) or placebo (PBO) subcutaneously administered with a syringe driver. Receives: Drug: rozanolixizumab; Other: Placebo
Cohort 2 <50 kg	Experimental	Study participants randomized to Cohort 2 will receive a single dose of rozanolixizumab (RLZ) or placebo (PBO) subcutaneously administered by manual push. Receives: Drug: rozanolixizumab; Other: Placebo
Cohort 3 >=50 kg	Experimental	Study participants randomized to Cohort 3 will receive a single dose of rozanolixizumab (RLZ) or placebo (PBO) subcutaneously administered with a syringe driver. Receives: Drug: rozanolixizumab; Other: Placebo
Cohort 4 >=50 kg	Experimental	Study participants randomized to Cohort 4 will receive a single dose of rozanolixizumab (RLZ) or placebo (PBO) subcutaneously administered by manual push. Receives: Drug: rozanolixizumab; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
A TEAE was defined as any adverse event (AE) with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication.
Measured: From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)

Secondary outcomes (6)

Maximum Plasma Concentration (Cmax) of a Single Dose Rozanolixizumab
Cmax was the maximum plasma concentration of a single dose rozanolixizumab. Cmax was measured in micrograms per millilitre per milligram (ug/mL/mg).
Measured: Sampling time points for plasma Pharmacokinetics were as follows: predose, immediately at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, and 16
Time to Maximum Plasma Concentration (Tmax) of a Single Dose Rozanolixizumab
tmax was the time to maximum plasma concentration of a single dose rozanolixizumab.
Measured: Sampling time points for plasma Pharmacokinetics were as follows: predose, immediately at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, and 16
Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC0-t) of a Single Dose Rozanolixizumab
AUC0-t was the area under the plasma concentration-time curve from time zero to time t of a single dose rozanolixizumab.
Measured: Sampling time points for plasma Pharmacokinetics were as follows: predose, immediately at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, and 16
Baseline-corrected Area Under the Total Immunglobulin (Ig) G-time Curve
Area under the baseline-corrected total IgG response curve from time 0 to time t.
Measured: Sampling time points for total IgG were as follows: 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, 16, 19, 22, 29, 43 and 57
Percent Maximum Decrease in Total Plasma IgG (Rmin) of a Single Dose Rozanolixizumab or Placebo
Rmin was the maximum (max) decrease in total plasma IgG of a single dose rozanolixizumab or placebo.
Measured: Sampling time points for total IgG were as follows: 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, 16, 19, 22, 29, 43 and 57
Time to Minimum IgG Level (Tmin) of a Single Dose Rozanolixizumab or Placebo
tmin was the time to minimum IgG level of a single dose rozanolixizumab or placebo.
Measured: Sampling time points for total IgG were as follows: 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, 16, 19, 22, 29, 43 and 57

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Apr 202111 Apr 2022

First posted2 Apr 2021
Study start22 Apr 2021
Primary completion11 Apr 2022
Study completion11 Apr 2022

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 Healthy Study ParticipantsStudies of the same condition, open and under way.
More trials run by UCB Biopharma SRLThe 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: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04828343
Sponsor's protocol ID: UP0106
Status last verified: Jul 2023
First submitted: 30 Mar 2021
Last updated: 7 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Participant-Blind, Investigator-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Rozanolixizumab Administered Subcutaneously Via Manual Push Versus Syringe Driver to Healthy Participants
ClinicalTrials.gov ID: NCT04828343
Acronym / sponsor ID: UP0106
Conditions: Healthy Study Participants
Keywords: Healthy Study Participants, Phase 1, rozanolixizumab, manual push, syringe driver
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: UCB Biopharma SRLIndustry (pharma, biotech, devices)
Study start: 22 Apr 2021 (actual)
Primary completion: 11 Apr 2022 (actual)
Study completion: 11 Apr 2022 (actual)
First posted: 2 Apr 2021 (actual)
Results: Posted 7 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Cohort 1 <50 kg	Experimental	Drug: rozanolixizumab, Other: PlaceboStudy participants randomized to Cohort 1 will receive a single dose of rozanolixizumab (RLZ) or placebo (PBO) subcutaneously administered with a syringe driver.
Cohort 2 <50 kg	Experimental	Drug: rozanolixizumab, Other: PlaceboStudy participants randomized to Cohort 2 will receive a single dose of rozanolixizumab (RLZ) or placebo (PBO) subcutaneously administered by manual push.
Cohort 3 >=50 kg	Experimental	Drug: rozanolixizumab, Other: PlaceboStudy participants randomized to Cohort 3 will receive a single dose of rozanolixizumab (RLZ) or placebo (PBO) subcutaneously administered with a syringe driver.
Cohort 4 >=50 kg	Experimental	Drug: rozanolixizumab, Other: PlaceboStudy participants randomized to Cohort 4 will receive a single dose of rozanolixizumab (RLZ) or placebo (PBO) subcutaneously administered by manual push.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Study participant must be 18 to 65 years of age, inclusive
Study participants who are overtly healthy in the opinion of the investigator as determined by medical evaluation including medical history, a general clinical examination, including physical examination and laboratory tests, and cardiac monitoring
Study participant has blood pressure (BP) and pulse within normal range in a supine position after 5 minutes of rest (systolic BP: 90 to 140 mmHg, diastolic BP: 50 to 90 mmHg, pulse: 40 to 90 beats per minute (bpm))
Study participant has clinical laboratory test results within the reference ranges of the testing laboratory or not clinically significant if outside the specified ranges, in the opinion of the investigator
Study participant's electrocardiogram (ECG) is considered "normal" or "abnormal but clinically nonsignificant" (as interpreted by the investigator)

Key exclusion criteria (30 listed)

History or presence of/significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders. Has active neoplastic disease or history of neoplastic disease within the previous 5 years of entry in the clinical study (except for basal or squamous cell carcinoma of the skin or carcinoma in situ that has been definitively treated with standard of care approaches). Has a history of a major organ transplant or hematopoietic stem cell/marrow transplant
Symptomatic herpes zoster within 3 months prior to Screening
Allergies to humanized monoclonal antibodies
Female who is pregnant or lactating
Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe posttreatment hypersensitivity reactions

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
rozanolixizumabAlso: RLZStudy participants will receive a single dose rozanolixizumab subcutaneously administered by manual push or a syringe driver.	Drug	Cohort 1 <50 kg, Cohort 2 <50 kg, Cohort 3 >=50 kg, Cohort 4 >=50 kg
PlaceboAlso: PBOStudy participants will receive a single dose placebo subcutaneously administered by manual push or a syringe driver.	Other	Cohort 1 <50 kg, Cohort 2 <50 kg, Cohort 3 >=50 kg, Cohort 4 >=50 kg

Primary outcome

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any adverse event (AE) with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication.

6 secondary outcomes

Maximum Plasma Concentration (Cmax) of a Single Dose Rozanolixizumab
Time frame: Sampling time points for plasma Pharmacokinetics were as follows: predose, immediately at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, and 16
Time to Maximum Plasma Concentration (Tmax) of a Single Dose Rozanolixizumab
Time frame: Sampling time points for plasma Pharmacokinetics were as follows: predose, immediately at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, and 16
Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC0-t) of a Single Dose Rozanolixizumab
Time frame: Sampling time points for plasma Pharmacokinetics were as follows: predose, immediately at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, and 16
Baseline-corrected Area Under the Total Immunglobulin (Ig) G-time Curve
Time frame: Sampling time points for total IgG were as follows: 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, 16, 19, 22, 29, 43 and 57
Percent Maximum Decrease in Total Plasma IgG (Rmin) of a Single Dose Rozanolixizumab or Placebo
Time frame: Sampling time points for total IgG were as follows: 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, 16, 19, 22, 29, 43 and 57
Time to Minimum IgG Level (Tmin) of a Single Dose Rozanolixizumab or Placebo
Time frame: Sampling time points for total IgG were as follows: 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, 16, 19, 22, 29, 43 and 57

Results and safety

Results posted to the registry on 7 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1: Syringe Driver- RLZ Dose 1 (>=35 kg to <50 kg)	6	6
Cohort 1: Syringe Driver- PBO (>=35 kg to <50 kg)	2	2
Cohort 2: Manual Push- RLZ Dose 2 (>=35 kg to <50 kg)	6	6
Cohort 2: Manual Push- PBO (>=35 kg to <50 kg)	2	2
Cohort 3: Syringe Driver- RLZ Dose 1 (>=50 kg)	6	6
Cohort 3: Syringe Driver- PBO (>=50 kg)	2	2
Cohort 4: Manual Push- RLZ Dose 1 (>=50 kg)	6	6
Cohort 4: Manual Push- PBO (>=50 kg)	2	2

Primary outcome: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)

Time frame: From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57). Number. Unit: percentage of participants

Measure	Cohort 1: Syringe Driver- RLZ Dose 1 (>=35 kg to <50 kg) n = 6	Cohort 1: Syringe Driver- PBO (>=35 kg to <50 kg) n = 2	Cohort 2: Manual Push- RLZ Dose 2 (>=35 kg to <50 kg) n = 6	Cohort 2: Manual Push- PBO (>=35 kg to <50 kg) n = 2	Cohort 3: Syringe Driver- RLZ Dose 1 (>=50 kg) n = 6	Cohort 3: Syringe Driver- PBO (>=50 kg) n = 2	Cohort 4: Manual Push- RLZ Dose 1 (>=50 kg) n = 6	Cohort 4: Manual Push- PBO (>=50 kg) n = 2
Value	83.3	50.0	100	50.0	83.3	0	83.3	100

Population analysed: The Safety Analysis Set (SS) included all randomized study participants who received IMP.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1: Syringe Driver- RLZ Dose 1 (>=35 kg to <50 kg)	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Cohort 1: Syringe Driver- PBO (>=35 kg to <50 kg)	0 of 2 (0%)	1 of 2 (50%)	0 of 2
Cohort 2: Manual Push- RLZ Dose 2 (>=35 kg to <50 kg)	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Cohort 2: Manual Push- PBO (>=35 kg to <50 kg)	0 of 2 (0%)	1 of 2 (50%)	0 of 2
Cohort 3: Syringe Driver- RLZ Dose 1 (>=50 kg)	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Cohort 3: Syringe Driver- PBO (>=50 kg)	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Cohort 4: Manual Push- RLZ Dose 1 (>=50 kg)	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Cohort 4: Manual Push- PBO (>=50 kg)	0 of 2 (0%)	2 of 2 (100%)	0 of 2

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.

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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.

UCB Cares study director

001 844 599 2273

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 rozanolixizumab in people with Healthy Study Participants, run by UCB Biopharma SRL 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 7 inclusion and 30 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 7 Mar 2024. 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?

Yes. Results are posted in the registry (first posted 7 Mar 2024). 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?

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) (time frame: From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04828343.

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 7 Mar 2024.