HealthyPhase 1NCT05428696
Safety and Tolerability, PK, and PD Study of Single and Multiple ALXN2080 Doses in Healthy Participants
A Phase 1 study testing ALXN2080 in people with Healthy, run by Alexion Pharmaceuticals, Inc. at 1 site in United Kingdom.
Trial summary
This study is designed to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses of ALXN2080 in healthy adult participants. 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?
- ALXN2080
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Sep 2022to 26 May 2023
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy is defined as having no clinically relevant abnormalities identified by a detailed medical history, physical examination, blood pressure and heart rate measurements, 12-lead ECG, and clinical laboratory tests.
- Body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg. BMI max is 32 kg/m2.
- Male or female; female of childbearing potential and male participants agreed to follow protocol specified contraception guidance.
Who cannot join
- Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders.
- History of hypersensitivity to any ingredient contained in the study intervention.
- Evidence of active infections, history of meningococcal infection, unexplained, or recurrent infection.
- Known or suspected history of drug or alcohol abuse or dependence.
- Current tobacco users or smokers.
- Diseases or conditions or previous procedures known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- For females: pregnant, breastfeeding, or intending to conceive during the course of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled First-in-Human Study of Single and Multiple Doses of ALXN2080 in Healthy Participants
This study is designed to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses of ALXN2080 in healthy adult participants.
Read the detailed description
Participants will be assigned to 10 different cohorts (6 SAD cohorts and 4 MAD cohorts), each with 8 participants on active treatment with ALXN2080 and 2 participants on placebo. ALXN2080 will be administered under fasted conditions throughout this study, except for the last SAD Cohort 6 in which ALXN2080 will be given with food to evaluate the effect of food on the single-dose pharmacokinetics of ALXN2080.
- Conditions
- Healthy
- Being tested
- ALXN2080, Placebo
- Keywords
- ALXN2080, Complement system, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALXN2080Drug
Powder-in-capsule
PlaceboDrug
Powder-in-capsule
| Study group | Role | What they receive |
|---|---|---|
| SAD - Cohort 1 | Experimental | Eight participants will receive a single dose of Dose Amount 1 of ALXN2080, and 2 participants will receive placebo. Receives: Drug: ALXN2080; Drug: Placebo |
| SAD - Cohort 2 | Experimental | Eight participants will receive a single dose of Dose Amount 2 of ALXN2080, and 2 participants will receive placebo. Receives: Drug: ALXN2080; Drug: Placebo |
| SAD - Cohort 3 | Experimental | Eight participants will receive a single dose of Dose Amount 3 of ALXN2080, and 2 participants will receive placebo. Receives: Drug: ALXN2080; Drug: Placebo |
| SAD - Cohort 4 | Experimental | Eight participants will receive a single dose of Dose Amount 4 of ALXN2080, and 2 participants will receive placebo. Receives: Drug: ALXN2080; Drug: Placebo |
| SAD - Cohort 5 | Experimental | Eight participants will receive a single dose of Dose Amount 5 of ALXN2080, and 2 participants will receive placebo. Receives: Drug: ALXN2080; Drug: Placebo |
| SAD - Cohort 6 | Experimental | Eight participants will receive a single dose of Dose Amount 6 of ALXN2080, and 2 participants will receive placebo. Receives: Drug: ALXN2080; Drug: Placebo |
| MAD - Cohort 1 | Experimental | Eight participants will receive multiple doses of Dose Amount A of ALXN2080 at a Dosing Frequency 1, and 2 participants will receive placebo for 14 days. Receives: Drug: ALXN2080; Drug: Placebo |
| MAD - Cohort 2 | Experimental | Eight participants will receive multiple doses of Dose Amount B of ALXN2080 at a Dosing Frequency 1, and 2 participants will receive placebo for 14 days. Receives: Drug: ALXN2080; Drug: Placebo |
| MAD - Cohort 3 | Experimental | Eight participants will receive multiple doses of Dose Amount C of ALXN2080 at a Dosing Frequency 1 or Frequency 2, and 2 participants will receive placebo for 14 days. Receives: Drug: ALXN2080; Drug: Placebo |
| MAD - Cohort 4 | Experimental | Eight participants will receive multiple doses of Dose Amount D of ALXN2080 at a Dosing Frequency 1 or Frequency 2, and 2 participants will receive placebo for 14 days. Receives: Drug: ALXN2080; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured: Day 1 through up to Day 28
Secondary outcomes (2)
Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) Of Single Dose ALXN2080
Measured: Up to 168 hours postdose
Maximum Observed Plasma Concentration (Cmax) of Single Dose ALXN2080
Measured: Up to 168 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start12 Sep 2022
- Primary completion24 Apr 2023
- Study completion26 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428696
- Sponsor's protocol ID
- ALXN2080-HV-101
- Status last verified
- Jun 2024
- First submitted
- 26 Apr 2022
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled First-in-Human Study of Single and Multiple Doses of ALXN2080 in Healthy Participants
- ClinicalTrials.gov ID
- NCT05428696
- Acronym / sponsor ID
- ALXN2080-HV-101
- Conditions
- Healthy
- Keywords
- ALXN2080, Complement system, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 24 Apr 2023 (actual)
- Study completion
- 26 May 2023 (actual)
- First posted
- 23 Jun 2022 (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.
This study is designed to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses of ALXN2080 in healthy adult participants.
Detailed description
Participants will be assigned to 10 different cohorts (6 SAD cohorts and 4 MAD cohorts), each with 8 participants on active treatment with ALXN2080 and 2 participants on placebo. ALXN2080 will be administered under fasted conditions throughout this study, except for the last SAD Cohort 6 in which ALXN2080 will be given with food to evaluate the effect of food on the single-dose pharmacokinetics of ALXN2080.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| SAD - Cohort 1 | Experimental | Drug: ALXN2080, Drug: PlaceboEight participants will receive a single dose of Dose Amount 1 of ALXN2080, and 2 participants will receive placebo. |
| SAD - Cohort 2 | Experimental | Drug: ALXN2080, Drug: PlaceboEight participants will receive a single dose of Dose Amount 2 of ALXN2080, and 2 participants will receive placebo. |
| SAD - Cohort 3 | Experimental | Drug: ALXN2080, Drug: PlaceboEight participants will receive a single dose of Dose Amount 3 of ALXN2080, and 2 participants will receive placebo. |
| SAD - Cohort 4 | Experimental | Drug: ALXN2080, Drug: PlaceboEight participants will receive a single dose of Dose Amount 4 of ALXN2080, and 2 participants will receive placebo. |
| SAD - Cohort 5 | Experimental | Drug: ALXN2080, Drug: PlaceboEight participants will receive a single dose of Dose Amount 5 of ALXN2080, and 2 participants will receive placebo. |
| SAD - Cohort 6 | Experimental | Drug: ALXN2080, Drug: PlaceboEight participants will receive a single dose of Dose Amount 6 of ALXN2080, and 2 participants will receive placebo. |
| MAD - Cohort 1 | Experimental | Drug: ALXN2080, Drug: PlaceboEight participants will receive multiple doses of Dose Amount A of ALXN2080 at a Dosing Frequency 1, and 2 participants will receive placebo for 14 days. |
| MAD - Cohort 2 | Experimental | Drug: ALXN2080, Drug: PlaceboEight participants will receive multiple doses of Dose Amount B of ALXN2080 at a Dosing Frequency 1, and 2 participants will receive placebo for 14 days. |
| MAD - Cohort 3 | Experimental | Drug: ALXN2080, Drug: PlaceboEight participants will receive multiple doses of Dose Amount C of ALXN2080 at a Dosing Frequency 1 or Frequency 2, and 2 participants will receive placebo for 14 days. |
| MAD - Cohort 4 | Experimental | Drug: ALXN2080, Drug: PlaceboEight participants will receive multiple doses of Dose Amount D of ALXN2080 at a Dosing Frequency 1 or Frequency 2, and 2 participants will receive placebo for 14 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy is defined as having no clinically relevant abnormalities identified by a detailed medical history, physical examination, blood pressure and heart rate measurements, 12-lead ECG, and clinical laboratory tests.
- Body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg. BMI max is 32 kg/m2.
- Male or female; female of childbearing potential and male participants agreed to follow protocol specified contraception guidance.
Key exclusion criteria (7 listed)
- Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders.
- History of hypersensitivity to any ingredient contained in the study intervention.
- Evidence of active infections, history of meningococcal infection, unexplained, or recurrent infection.
- Known or suspected history of drug or alcohol abuse or dependence.
- Current tobacco users or smokers.
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 |
|---|---|---|
| ALXN2080Powder-in-capsule | Drug | MAD - Cohort 1, MAD - Cohort 2, MAD - Cohort 3, MAD - Cohort 4, SAD - Cohort 1, SAD - Cohort 2, SAD - Cohort 3, SAD - Cohort 4, SAD - Cohort 5, SAD - Cohort 6 |
| PlaceboPowder-in-capsule | Drug | MAD - Cohort 1, MAD - Cohort 2, MAD - Cohort 3, MAD - Cohort 4, SAD - Cohort 1, SAD - Cohort 2, SAD - Cohort 3, SAD - Cohort 4, SAD - Cohort 5, SAD - Cohort 6 |
Primary outcome
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 through up to Day 28
2 secondary outcomes
Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) Of Single Dose ALXN2080
Time frame: Up to 168 hours postdose
Maximum Observed Plasma Concentration (Cmax) of Single Dose ALXN2080
Time frame: Up to 168 hours postdose
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 7 Jun 2024.
- 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.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 ALXN2080 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 7 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 Jun 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?
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 Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: Day 1 through up to Day 28). 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 7 Jun 2024.