HealthyPhase 1NCT04952545
Study of ALXN2050 in Healthy Adult Participants of Japanese Descent
A Phase 1 study testing ALXN2050 in people with Healthy, run by Alexion Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This is a Phase 1 bridging study being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ALXN2050 after both single- and multiple-dosing in healthy participants of Japanese descent. 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?
- ALXN2050
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2021to 7 Sep 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Medically healthy with no clinically significant or relevant abnormalities as determined by medical history, physical or neurological examination, vital signs, 12-lead electrocardiogram, screening clinical laboratory profiles.
- Participants must be of Japanese descent defined as:
- First generation (born to 2 Japanese parents and 4 Japanese grandparents);
- Born in Japan, and not have lived outside Japan for greater than 5 years;
- Lifestyle, including diet, must not have significantly changed since leaving Japan.
- Participants must be able to speak, read, and understand the Japanese and English languages.
- Body mass index within the range 18.5 to 30.0 kilograms (kg)/meter squared, inclusive, with a minimum body weight of 50.0 kg at Screening.
Who cannot join
- History of any medical or psychiatric condition or disease that, in the opinion of the Investigator or designee, might limit the participant's ability to complete or participate in this clinical study, confound the results of the study, or pose an additional risk to the participant by their participation in the study.
- History of significant multiple and/or severe allergies.
- Any previous procedure that could alter absorption or excretion of orally administered drugs.
- Participation in another investigational drug or investigational device study within 5 half-lives (if known) or 30 days prior to the first dose of study intervention, whichever is longer.
- Body temperature ≥ 38.0°Celcius, at Screening or prior to the first dose of study intervention.
- History of drug or alcohol abuse within 2 years prior to the first dose of study intervention or positive drugs-of-abuse or alcohol screen at Screening or Day -1; current tobacco/nicotine users or smokers or a positive cotinine test at Screening.
- Donation of whole blood from 3 months prior to the first dose of study intervention, or of plasma from 30 days prior to the first dose of study intervention; receipt of blood products within 6 months prior to the first dose of study intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study to Determine the Safety, Tolerability, and Pharmacokinetics of ALXN2050 in Healthy Participants of Japanese Descent
This is a Phase 1 bridging study being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ALXN2050 after both single- and multiple-dosing in healthy participants of Japanese descent.
- Conditions
- Healthy
- Being tested
- ALXN2050, Placebo
- Keywords
- ALXN2050, Pharmacokinetics, Pharmacodynamics, Japanese Descent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALXN2050Drug
Also called ACH-0145228 (formerly)
Oral tablet.
PlaceboDrug
Oral tablet.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: ALXN2050 (Dose 1) | Experimental | Participants will receive ALXN2050 (Dose 1) as follows under fasting conditions: 120-milligrams (mg) single dose, 3-day washout, then 120-mg twice daily (BID) dosing. Receives: Drug: ALXN2050 |
| Cohort 1: Placebo (Dose 1) | Experimental | Participants will receive placebo (Dose 1) as follows under fasting conditions: 120-mg placebo single dose, 3-day washout, then 120-mg placebo BID dosing. Receives: Drug: Placebo |
| Cohort 2: ALXN2050 (Dose 2) | Experimental | Participants will receive ALXN2050 (Dose 2) as follows under fasting conditions: 180-mg single dose, 3-day washout, then 180-mg BID dosing. Receives: Drug: ALXN2050 |
| Cohort 2: Placebo (Dose 2) | Experimental | Participants will receive placebo (Dose 2) as follows under fasting conditions: 180-mg placebo single dose, 3-day washout, then 180-mg placebo BID dosing. 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
see Time Frame - defined
Measured: Day 1 (after first dose) through follow-up (7 +/- 2 days after final dose)
Area Under The Concentration-time Curve From Time Zero To Infinity (AUCinf) For Single-dose ALXN2050
see Time Frame - defined
Measured: Up to 72 hours postdose
Maximum Plasma Concentration (Cmax) For Single-dose ALXN2050
see Time Frame - defined
Measured: Up to 72 hours postdose
Time To Maximum Plasma Concentration (Tmax) For Single-dose ALXN2050
see Time Frame - defined
Measured: Up to 72 hours postdose
Area Under The Concentration-time Curve From Time Zero To The 12-hour Time Point (AUC0-12) For Multiple-dose ALXN2050
see Time Frame - defined
Measured: Up to 72 hours postdose
Cmax For Multiple-dose ALXN2050
see Time Frame - defined
Measured: Up to 72 hours postdose
Tmax For Multiple-dose ALXN2050
see Time Frame - defined
Measured: Up to 72 hours postdose
Secondary outcomes (2)
Alternative Pathway Activity As Measured By Wieslab Assay
see Time Frame - defined
Measured: Up to 72 hours postdose
Complement Factor B Fraction b Levels
see Time Frame - defined
Measured: Up to 72 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start9 Jul 2021
- Primary completion7 Sep 2021
- Study completion7 Sep 2021
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 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
- NCT04952545
- Sponsor's protocol ID
- ALXN2050-HV-113
- Status last verified
- Dec 2022
- First submitted
- 28 Jun 2021
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Determine the Safety, Tolerability, and Pharmacokinetics of ALXN2050 in Healthy Participants of Japanese Descent
- ClinicalTrials.gov ID
- NCT04952545
- Acronym / sponsor ID
- ALXN2050-HV-113
- Conditions
- Healthy
- Keywords
- ALXN2050, Pharmacokinetics, Pharmacodynamics, Japanese Descent
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jul 2021 (actual)
- Primary completion
- 7 Sep 2021 (actual)
- Study completion
- 7 Sep 2021 (actual)
- First posted
- 7 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1 bridging study being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ALXN2050 after both single- and multiple-dosing in healthy participants of Japanese descent.
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: ALXN2050 (Dose 1) | Experimental | Drug: ALXN2050Participants will receive ALXN2050 (Dose 1) as follows under fasting conditions: 120-milligrams (mg) single dose, 3-day washout, then 120-mg twice daily (BID) dosing. |
| Cohort 1: Placebo (Dose 1) | Experimental | Drug: PlaceboParticipants will receive placebo (Dose 1) as follows under fasting conditions: 120-mg placebo single dose, 3-day washout, then 120-mg placebo BID dosing. |
| Cohort 2: ALXN2050 (Dose 2) | Experimental | Drug: ALXN2050Participants will receive ALXN2050 (Dose 2) as follows under fasting conditions: 180-mg single dose, 3-day washout, then 180-mg BID dosing. |
| Cohort 2: Placebo (Dose 2) | Experimental | Drug: PlaceboParticipants will receive placebo (Dose 2) as follows under fasting conditions: 180-mg placebo single dose, 3-day washout, then 180-mg placebo BID dosing. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Medically healthy with no clinically significant or relevant abnormalities as determined by medical history, physical or neurological examination, vital signs, 12-lead electrocardiogram, screening clinical laboratory profiles.
- Participants must be of Japanese descent defined as:
- Participants must be able to speak, read, and understand the Japanese and English languages.
- Body mass index within the range 18.5 to 30.0 kilograms (kg)/meter squared, inclusive, with a minimum body weight of 50.0 kg at Screening.
Key exclusion criteria (7 listed)
- History of any medical or psychiatric condition or disease that, in the opinion of the Investigator or designee, might limit the participant's ability to complete or participate in this clinical study, confound the results of the study, or pose an additional risk to the participant by their participation in the study.
- History of significant multiple and/or severe allergies.
- Any previous procedure that could alter absorption or excretion of orally administered drugs.
- Participation in another investigational drug or investigational device study within 5 half-lives (if known) or 30 days prior to the first dose of study intervention, whichever is longer.
- Body temperature ≥ 38.0°Celcius, at Screening or prior to the first dose of study intervention.
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 |
|---|---|---|
| ALXN2050Also: ACH-0145228 (formerly)Oral tablet. | Drug | Cohort 1: ALXN2050 (Dose 1), Cohort 2: ALXN2050 (Dose 2) |
| PlaceboOral tablet. | Drug | Cohort 1: Placebo (Dose 1), Cohort 2: Placebo (Dose 2) |
Primary outcome
Number Of Participants With Treatment-emergent Adverse Events
Time frame: Day 1 (after first dose) through follow-up (7 +/- 2 days after final dose)
see Time Frame - defined
Area Under The Concentration-time Curve From Time Zero To Infinity (AUCinf) For Single-dose ALXN2050
Time frame: Up to 72 hours postdose
see Time Frame - defined
Maximum Plasma Concentration (Cmax) For Single-dose ALXN2050
Time frame: Up to 72 hours postdose
see Time Frame - defined
Time To Maximum Plasma Concentration (Tmax) For Single-dose ALXN2050
Time frame: Up to 72 hours postdose
see Time Frame - defined
Area Under The Concentration-time Curve From Time Zero To The 12-hour Time Point (AUC0-12) For Multiple-dose ALXN2050
Time frame: Up to 72 hours postdose
see Time Frame - defined
Cmax For Multiple-dose ALXN2050
Time frame: Up to 72 hours postdose
see Time Frame - defined
Tmax For Multiple-dose ALXN2050
Time frame: Up to 72 hours postdose
see Time Frame - defined
2 secondary outcomes
Alternative Pathway Activity As Measured By Wieslab Assay
Time frame: Up to 72 hours postdose
Complement Factor B Fraction b Levels
Time frame: Up to 72 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 9 Dec 2022.
- Individual participant dataSharing planned: No
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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 ALXN2050 in people with Healthy, run by Alexion Pharmaceuticals, Inc. at 1 site in United States.
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 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 9 Dec 2022. 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 States. 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 With Treatment-emergent Adverse Events (time frame: Day 1 (after first dose) through follow-up (7 +/- 2 days after final dose)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2022.