HealthyPhase 1NCT05307978

Safety and Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ALXN1910 in Healthy Participants

A Phase 1 study testing ALXN1910 in people with Healthy, run by Alexion Pharmaceuticals, Inc. 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

Search all trials

Trial summary

This is a Phase 1, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of single ascending doses (SADs) of ALXN1910 subcutaneous (SC) and SAD of ALXN1910 intravenous (IV). Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: ALXN1910
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 48 participants
Where: 1 siteUnited Kingdom
Study dates: 12 Apr 2022to 7 Feb 2023
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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy participants
Participants of Japanese descent are defined as: First generation (born to 2 Japanese parents and 4 Japanese grandparents).
Participants of Japanese descent must be between 20 and 55 years of age.

Who cannot join

Current or recurrent disease
Current or relevant history of physical or psychiatric illness.
Any other significant disease or disorder that, in the opinion of the Investigator, may put the participant at risk.
History of significant allergic reaction (eg, anaphylaxis or angioedema) to any product (eg, food, pharmaceutical).
Female participants who are pregnant or breastfeeding.
Major surgery or hospitalization within 90 days prior to dosing on Day1.
History of exposure to asfotase alfa.
History of allergy or hypersensitivity to excipients of asfotase alfa or ALXN1910 (eg,sodium phosphate, sodium chloride).

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Clinical Trial Site
Harrow, HA1 3UJ

Other trials in United Kingdom

About this study

Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study of Subcutaneously and Intravenously Administered ALXN1910 in Healthy Adult Participants

Conditions: Healthy
Being tested: ALXN1910, Placebo
Keywords: ALXN1910, Safety, Pharmacokinetics, Pharmacodynamics, Japanese Descent

What participants receive

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

ALXN1910Drug
Participants will receive a single dose of ALXN1910 IV or ALXN1910 SC according to their assigned cohort.
PlaceboDrug
Participants will receive Placebo IV or Placebo SC according to their assigned cohort.

Study groups in NCT05307978
Study group	Role	What they receive
Cohort 1	Experimental	Participants will receive a single dose of 5 mg of ALXN1910 IV or Placebo IV. Receives: Drug: ALXN1910; Drug: Placebo
Cohort 2	Experimental	Participants will receive a single dose of 15 mg of ALXN1910 SC or Placebo SC. Receives: Drug: ALXN1910; Drug: Placebo
Cohort 3	Experimental	Participant will receive a single dose of 15 mg of ALXN1910 IV or Placebo IV. Receives: Drug: ALXN1910; Drug: Placebo
Cohort 4	Experimental	Japanese participants will receive a single dose of 15 mg of ALXN1910 SC or Placebo SC. Receives: Drug: ALXN1910; Drug: Placebo
Cohort 5	Experimental	Participants will receive a single dose of 45 mg of ALXN1910 SC or Placebo SC. Receives: Drug: ALXN1910; Drug: Placebo
Cohort 6	Experimental	Participants will receive a single dose of 135 mg of ALXN1910 SC or Placebo SC. Receives: Drug: ALXN1910; 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) and Treatment-Emergent Serious Adverse Events (TESAEs)
The safety and tolerability of ALXN1910 was assessed.
Measured: Day 1 (postdose) through Day 75

Secondary outcomes (23)

Maximum Observed Serum Concentration (Cmax)
The Cmax was assessed as PK parameter of single ascending doses of ALXN1910.
Measured: Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75
Time to Maximum Observed Serum Concentration (Tmax)
The Tmax was assed as PK parameter of single ascending doses of ALXN1910.
Measured: Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75
Apparent Terminal Elimination Half Life (t1/2)
The t1/2 was assed as PK parameter of single ascending doses of ALXN1910.
Measured: Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75
Terminal-phase Elimination Rate Constant (λz)
The λz was assed as PK parameter of single ascending doses of ALXN1910.
Measured: Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75
AUC From Time Zero to the Last Quantifiable Concentratio (AUCt)
The AUCt was assed as PK parameter of single ascending doses of ALXN1910.
Measured: Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75
AUC From Time Zero Extrapolated to Infinity (AUC∞)
The AUC∞ was assed as PK parameter of single ascending doses of ALXN1910.
Measured: Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75
AUC From Time Zero to 168h (AUC0-168)
The AUC0-168 was assed as PK parameter of single ascending doses of ALXN1910.
Measured: Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75
Percentage of AUC∞ Obtained by Extrapolation Beyond Tlast (%AUCex)
The %AUCex was assed as PK parameter of single ascending doses of ALXN1910.
Measured: Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75
Total Body Clearance (for IV Cohorts) or Apparent Clearance (for SC Cohorts) (CL or CL/F)
The CL or CL/F was assed as PK parameter of single ascending doses of ALXN1910.
Measured: Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75
Volume of Distribution (for IV Cohorts) or Apparent Volume of Distribution (for SC Cohorts) (Vd or Vd/F)
The Vd or Vd/F was assed as PK parameter of single ascending doses of ALXN1910.
Measured: Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75
Plasma Concentration of Inorganic Pyrophosphate (PPi)
The plasma concentrations of PPi was assesed.
Measured: Day 1 (predose), 2, 3, 5, 8, 15, 22, 29, 36, 43, and 75
Plasma Concentration of Pyridoxal (PL)
The plasma concentrations of PL was assessed.
Measured: Day 1 (predose), 2, 3, 5, 8, 15, 22, 29, 36, 43, and 75
Plasma Concentration of Pyridoxal 5-Phosphate (PLP)
The plasma concentrations of PLP was assessed.
Measured: Day 1 (predose), 2, 3, 5, 8, 15, 22, 29, 36, 43, and 75
Plasma Concentration of Pyridoxic Acid (PA)
The plasma concentrations of PA was assessed.
Measured: Day 1 (predose), 2, 3, 5, 8, 15, 22, 29, 36, 43, and 75
Number of Participants With Positive Treatment-Emergent Antidrug Antibodies (ADAs)
The ADAs of ALXN1910 was assessed as immunogenicity parameter. Treatment-emergent ADA Responses is defined as a positive result in the ADA assay post first dose, when baseline results are negative or missing.
Measured: Day 1 (postdose) through Day 75
Geometric Mean Ratio (GMR) of Area Under the Curve (AUC∞) Values of Subcutaneous (SC) Versus Intravenous (IV) Serum Concentration of ALXN1910
The absolute bioavailability GMR AUC∞ of ALXN1910 SC was assessed.
Measured: Up to Day 75
Maximum Observed Serum Concentration (Cmax) in Japanese and Non-Japanese Participants
Quantitative assessment of PK parameter (Cmax) was assessed between Japanese and non-Japanese participants.
Measured: Up to Day 75
AUC From Time Zero to the Last Quantifiable Concentration (AUCt) in Japanese and Non-Japanese Participants
Quantitative assessment of PK parameter (AUCt) was assessed between Japanese and non-Japanese participants.
Measured: Up to Day 75
AUC From Time Zero Extrapolated to Infinity (AUC∞) in Japanese and Non-Japanese Participants
Quantitative assessment of PK parameter (AUC∞) was assessed between Japanese and non-Japanese participants.
Measured: Up to Day 75
Change From Baseline in Inorganic Pyrophosphate Concentration in Japanese and Non-Japanese Participants
Change from baseline in PD parameter Inorganic Pyrophosphate was evaluated over time for Japanese and non-Japanese participants (Cohort 2 versus Cohort 4) on active treatment.
Measured: Day 2, 15, 22, 43, and 75
Change From Baseline in Pyridoxal-5-phosphate Concentration in Japanese and Non-Japanese Participants
Change from baseline in PD parameter Pyridoxal-5-phosphate was evaluated over time for Japanese and non-Japanese participants (Cohort 2 versus Cohort 4) on active treatment
Measured: Day 2, 15, 22, 43, and 75
Change From Baseline in Pyridoxal Concentration in Japanese and Non-Japanese Participants
Change from baseline in PD parameter Pyridoxal was evaluated over time for Japanese and non-Japanese participants (Cohort 2 versus Cohort 4) on active treatment.
Measured: Day 2, 15, 22, 43, and 75
Change From Baseline in Pyridoxic Acid Concentration in Japanese and Non-Japanese Participants
Change from baseline in PD parameter Pyridoxic Acid was evaluated over time for Japanese and non-Japanese participants (Cohort 2 versus Cohort 4) on active treatment.
Measured: Day 2, 15, 22, 43, and 75

Timeline

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

12 Apr 20227 Feb 2023

First posted1 Apr 2022
Study start12 Apr 2022
Primary completion7 Feb 2023
Study completion7 Feb 2023

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: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05307978
Sponsor's protocol ID: ALXN1910-HV-101
Status last verified: Jan 2025
First submitted: 24 Mar 2022
Last updated: 27 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

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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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study of Subcutaneously and Intravenously Administered ALXN1910 in Healthy Adult Participants
ClinicalTrials.gov ID: NCT05307978
Acronym / sponsor ID: ALXN1910-HV-101
Conditions: Healthy
Keywords: ALXN1910, Safety, Pharmacokinetics, Pharmacodynamics, Japanese Descent
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 12 Apr 2022 (actual)
Primary completion: 7 Feb 2023 (actual)
Study completion: 7 Feb 2023 (actual)
First posted: 1 Apr 2022 (actual)
Results: Posted 27 Feb 2025

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: Triple blind (participant, care provider, investigator)
Number of arms: 6

Arm	Type	Receives
Cohort 1	Experimental	Drug: ALXN1910, Drug: PlaceboParticipants will receive a single dose of 5 mg of ALXN1910 IV or Placebo IV.
Cohort 2	Experimental	Drug: ALXN1910, Drug: PlaceboParticipants will receive a single dose of 15 mg of ALXN1910 SC or Placebo SC.
Cohort 3	Experimental	Drug: ALXN1910, Drug: PlaceboParticipant will receive a single dose of 15 mg of ALXN1910 IV or Placebo IV.
Cohort 4	Experimental	Drug: ALXN1910, Drug: PlaceboJapanese participants will receive a single dose of 15 mg of ALXN1910 SC or Placebo SC.
Cohort 5	Experimental	Drug: ALXN1910, Drug: PlaceboParticipants will receive a single dose of 45 mg of ALXN1910 SC or Placebo SC.
Cohort 6	Experimental	Drug: ALXN1910, Drug: PlaceboParticipants will receive a single dose of 135 mg of ALXN1910 SC or Placebo SC.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Healthy participants
Participants of Japanese descent are defined as: First generation (born to 2 Japanese parents and 4 Japanese grandparents).
Participants of Japanese descent must be between 20 and 55 years of age.

Key exclusion criteria (8 listed)

Current or recurrent disease
Current or relevant history of physical or psychiatric illness.
Any other significant disease or disorder that, in the opinion of the Investigator, may put the participant at risk.
History of significant allergic reaction (eg, anaphylaxis or angioedema) to any product (eg, food, pharmaceutical).
Female participants who are pregnant or breastfeeding.

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
ALXN1910Participants will receive a single dose of ALXN1910 IV or ALXN1910 SC according to their assigned cohort.	Drug	Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6
PlaceboParticipants will receive Placebo IV or Placebo SC according to their assigned cohort.	Drug	Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6

Primary outcome

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Time frame: Day 1 (postdose) through Day 75
The safety and tolerability of ALXN1910 was assessed.

23 secondary outcomes

Maximum Observed Serum Concentration (Cmax)
Time frame: Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75
Time to Maximum Observed Serum Concentration (Tmax)
Time frame: Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75
Apparent Terminal Elimination Half Life (t1/2)
Time frame: Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75
Terminal-phase Elimination Rate Constant (λz)
Time frame: Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75
AUC From Time Zero to the Last Quantifiable Concentratio (AUCt)
Time frame: Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75
AUC From Time Zero Extrapolated to Infinity (AUC∞)
Time frame: Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75
AUC From Time Zero to 168h (AUC0-168)
Time frame: Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75
Percentage of AUC∞ Obtained by Extrapolation Beyond Tlast (%AUCex)
Time frame: Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75
Total Body Clearance (for IV Cohorts) or Apparent Clearance (for SC Cohorts) (CL or CL/F)
Time frame: Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75
Volume of Distribution (for IV Cohorts) or Apparent Volume of Distribution (for SC Cohorts) (Vd or Vd/F)
Time frame: Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75
Plasma Concentration of Inorganic Pyrophosphate (PPi)
Time frame: Day 1 (predose), 2, 3, 5, 8, 15, 22, 29, 36, 43, and 75
Plasma Concentration of Pyridoxal (PL)
Time frame: Day 1 (predose), 2, 3, 5, 8, 15, 22, 29, 36, 43, and 75
Plasma Concentration of Pyridoxal 5-Phosphate (PLP)
Time frame: Day 1 (predose), 2, 3, 5, 8, 15, 22, 29, 36, 43, and 75
Plasma Concentration of Pyridoxic Acid (PA)
Time frame: Day 1 (predose), 2, 3, 5, 8, 15, 22, 29, 36, 43, and 75
Number of Participants With Positive Treatment-Emergent Antidrug Antibodies (ADAs)
Time frame: Day 1 (postdose) through Day 75
Geometric Mean Ratio (GMR) of Area Under the Curve (AUC∞) Values of Subcutaneous (SC) Versus Intravenous (IV) Serum Concentration of ALXN1910
Time frame: Up to Day 75
Maximum Observed Serum Concentration (Cmax) in Japanese and Non-Japanese Participants
Time frame: Up to Day 75
AUC From Time Zero to the Last Quantifiable Concentration (AUCt) in Japanese and Non-Japanese Participants
Time frame: Up to Day 75
AUC From Time Zero Extrapolated to Infinity (AUC∞) in Japanese and Non-Japanese Participants
Time frame: Up to Day 75
Change From Baseline in Inorganic Pyrophosphate Concentration in Japanese and Non-Japanese Participants
Time frame: Day 2, 15, 22, 43, and 75
Change From Baseline in Pyridoxal-5-phosphate Concentration in Japanese and Non-Japanese Participants
Time frame: Day 2, 15, 22, 43, and 75
Change From Baseline in Pyridoxal Concentration in Japanese and Non-Japanese Participants
Time frame: Day 2, 15, 22, 43, and 75
Change From Baseline in Pyridoxic Acid Concentration in Japanese and Non-Japanese Participants
Time frame: Day 2, 15, 22, 43, and 75

Results and safety

Results posted to the registry on 27 Feb 2025, 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- 5 mg	6	6
Cohort 2- 15 mg SC	6	5
Cohort 3- 15 mg IV	6	6
Japanese Cohort 4- 15 mg SC	6	2
Cohort 5- 45 mg	6	6
Cohort 6- 135 mg	6	6
Pooled Placebo	12	11

Primary outcome: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

Time frame: Day 1 (postdose) through Day 75. Count of participants. Unit: Participants

Measure	Cohort 1- 5 mg n = 6	Cohort 2- 15 mg SC n = 6	Cohort 3- 15 mg IV n = 6	Japanese Cohort 4- 15 mg SC n = 6	Cohort 5- 45 mg n = 6	Cohort 6- 135 mg n = 6	Pooled Placebo n = 12
Any TEAE	3	3	4	3	5	4	8
Any Serious TEAE	0	0	0	0	0	1	0
TEAE outcome of Death	0	0	0	0	0	0	0
AE Leading to Withdrawal of Study Drug	0	0	0	0	0	0	0
SAE Leading to Withdrawal of Study Drug	0	0	0	0	0	0	0

Population analysed: All participants who received any amount of study intervention were included in the Safety Analysis Set. Participants were analyzed according to the study intervention received.

23 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 (postdose) through Day 75. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1- 5 mg	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Cohort 2- 15 mg SC	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Cohort 3- 15 mg IV	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Japanese Cohort 4- 15 mg SC	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Cohort 5- 45 mg	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Cohort 6- 135 mg	1 of 6 (16.7%)	4 of 6 (66.7%)	0 of 6
Pooled Placebo	0 of 12 (0%)	8 of 12 (66.7%)	0 of 12

Limitations and caveats (from the sponsor): For Outcome measure #12 Plasma Concentration of Inorganic Pyrophosphate (PPi); #13 Plasma Concentration of Pyridoxal (PL); #14 Plasma Concentration of Pyridoxal 5-Phosphate (PLP); 15 Plasma Concentration of Pyridoxic Acid (PA); Cohort 4 Day 75 standard deviation is provided for the posting although standard deviation will not be calculated for less than 3 data points per study's Statistical Analysis Plan.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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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 ALXN1910 in people with Healthy, run by Alexion Pharmaceuticals, Inc. 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 3 inclusion and 8 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 27 Feb 2025. 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 27 Feb 2025). 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) and Treatment-Emergent Serious Adverse Events (TESAEs) (time frame: Day 1 (postdose) through Day 75). 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 NCT05307978.

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 27 Feb 2025.