HealthyPhase 1NCT05047484
A Study of Multiple Doses of ALXN2050 in Healthy Adults
A Phase 1 study testing ALXN2050 in people with Healthy, run by Alexion Pharmaceuticals, Inc. at 1 site in New Zealand.
Trial summary
This was a Phase 1, placebo-controlled, randomized, double-blind (participant and investigator blind, sponsor open), multiple-ascending dose study conducted in healthy participants to demonstrate the safety and tolerability and to evaluate the pharmacokinetics and pharmacodynamics of ACH-0145228 (ALXN2050). 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?
- ALXN2050
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteNew Zealand
- Study dates
- 7 Jan 2019to 23 Jul 2019
- 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Was overtly healthy as determined by medical evaluation including detailed medical history, physical examination, blood pressure and heart rate measurements, 12-lead ECG, and clinical laboratory tests.
- Had a body weight of at least 50 kilograms (kg) and body mass index within the range of 18 to 30 kg/meter squared (inclusive).
- Male participants were eligible to participate if they agreed to abstinence or use of a highly effective method of contraception.
- Female participants must have been of nonchildbearing potential.
Who cannot join
- Had a history or clinically relevant evidence of current cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disorders or conditions capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
- Had a body temperature greater than or equal to 38°Celsius on Day -1 or Day 1, Hour 0; had a history of febrile illness, or other evidence of infection, within 14 days prior to first study drug administration.
- Had a sensitivity to any of the study interventions, or components thereof, or drug or other allergy that contraindicated participation in the study.
- Donated blood or lost more than 500 milliliters of blood within 3 months prior to first study drug administration, or received a blood transfusion or blood products within 6 months prior to first study drug administration.
- Current enrollment or past participation within the last 30 days before study drug administration in any clinical study involving an investigational study intervention or any other type of medical research
- Had clinically significant laboratory abnormalities.
- Positive urine drug screen at Screening or Day -1; was a current tobacco/nicotine user or smoker; consumed any alcohol within 72 hours before first study drug administration or had a history of regular alcohol consumption within 6 months of screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACH-0145228 in Healthy Participants
This was a Phase 1, placebo-controlled, randomized, double-blind (participant and investigator blind, sponsor open), multiple-ascending dose study conducted in healthy participants to demonstrate the safety and tolerability and to evaluate the pharmacokinetics and pharmacodynamics of ACH-0145228 (ALXN2050).
- Conditions
- Healthy
- Being tested
- ALXN2050, Placebo
- Keywords
- Factor D Inhibitor, Complement, ALXN2050, ACH-0145228, Pharmacokinetics, Pharmacodynamics, Safety
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), ACH-5228
Powder-in-capsule (PIC).
PlaceboDrug
PIC.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: 40 mg ALXN2050/Placebo | Experimental | Participants randomized to receive ALXN2050 or placebo twice daily (BID) on Day 1 through Day 14 in a fasted state. Receives: Drug: ALXN2050; Drug: Placebo |
| Cohort 2: 80 mg ALXN2050/Placebo | Experimental | Participants randomized to receive ALXN2050 or placebo BID on Day 1 through Day 14 in a fasted state. Receives: Drug: ALXN2050; Drug: Placebo |
| Cohort 3: 120 mg ALXN2050/Placebo | Experimental | Participants randomized to receive ALXN2050 or placebo BID on Day 1 through Day 14 in a fasted state. Receives: Drug: ALXN2050; Drug: Placebo |
| Cohort 4: 200 mg ALXN2050/Placebo | Experimental | Participants randomized to receive ALXN2050 or placebo BID on Day 1 through Day 14 in a fasted state. Receives: Drug: ALXN2050; Drug: Placebo |
| Cohort 5: 120 mg ALXN2050/Placebo | Experimental | Participants randomized to receive a single dose of ALXN2050 or placebo on Day 1 in a fed state. Receives: Drug: ALXN2050; Drug: Placebo |
| Cohort 6: 240 mg ALXN2050/Placebo | Experimental | Participants randomized to receive a single dose of ALXN2050 or placebo on Day 1 in a fasted state. Receives: Drug: ALXN2050; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number Of Participants Experiencing Serious Adverse Events
Measured: Day 1 through Day 42
Number Of Participants Experiencing Grade 3 Or 4 Adverse Events (AEs)
Measured: Day 1 through Day 42
Number Of Participants Experiencing AEs Leading To Discontinuation From The Study
Measured: Day 1 through Day 42
Number Of Participants Experiencing Grade 3 Or 4 Laboratory Abnormalities
Measured: Day 1 through Day 42
Number Of Participants Experiencing Treatment-emergent Vital Signs, Physical Examination Results, And Electrocardiogram (ECG) Abnormalities
Measured: Day 1 through Day 42
Secondary outcomes (8)
Maximum Steady-state Plasma Concentration (Cmax,ss) Of Multiple-dose ALXN2050
Measured: Up to 168 hours postdose
Time To Reach Maximum Steady-state Plasma Concentration (Tmax,ss) Of Multiple-dose ALXN2050
Measured: Up to 168 hours postdose
Area Under The Plasma Concentration Versus Time Curve Over The Dosing Interval (AUCtau) Of Multiple-dose ALXN2050
Measured: Up to 168 hours postdose
Maximum Plasma Concentration (Cmax) Of Single-dose ALXN2050
Measured: Up to 72 hours postdose
Time To Reach Maximum Plasma Concentration (Tmax) Of Single-dose ALXN2050
Measured: Up to 72 hours postdose
Area Under The Concentration-time Curve Extrapolated To Infinity (AUC0-inf) For Single-dose ALXN2050
Measured: Up to 72 hours postdose
Alternative Pathway (AP) Activity As Measured By Wieslab Assay
Measured: Up to 14 days postdose
Plasma Bb Fragment Of Complement Factor B Concentration Over Time
Measured: Up to 14 days postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start7 Jan 2019
- Primary completion23 Jul 2019
- Study completion23 Jul 2019
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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Achillion, a wholly owned subsidiary of Alexion
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05047484
- Sponsor's protocol ID
- ACH228-002
- Status last verified
- Sep 2021
- First submitted
- 9 Sep 2021
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACH-0145228 in Healthy Participants
- ClinicalTrials.gov ID
- NCT05047484
- Acronym / sponsor ID
- ACH228-002
- Conditions
- Healthy
- Keywords
- Factor D Inhibitor, Complement, ALXN2050, ACH-0145228, Pharmacokinetics, Pharmacodynamics, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Achillion, a wholly owned subsidiary of Alexion
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 23 Jul 2019 (actual)
- Study completion
- 23 Jul 2019 (actual)
- First posted
- 17 Sep 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 was a Phase 1, placebo-controlled, randomized, double-blind (participant and investigator blind, sponsor open), multiple-ascending dose study conducted in healthy participants to demonstrate the safety and tolerability and to evaluate the pharmacokinetics and pharmacodynamics of ACH-0145228 (ALXN2050).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: 40 mg ALXN2050/Placebo | Experimental | Drug: ALXN2050, Drug: PlaceboParticipants randomized to receive ALXN2050 or placebo twice daily (BID) on Day 1 through Day 14 in a fasted state. |
| Cohort 2: 80 mg ALXN2050/Placebo | Experimental | Drug: ALXN2050, Drug: PlaceboParticipants randomized to receive ALXN2050 or placebo BID on Day 1 through Day 14 in a fasted state. |
| Cohort 3: 120 mg ALXN2050/Placebo | Experimental | Drug: ALXN2050, Drug: PlaceboParticipants randomized to receive ALXN2050 or placebo BID on Day 1 through Day 14 in a fasted state. |
| Cohort 4: 200 mg ALXN2050/Placebo | Experimental | Drug: ALXN2050, Drug: PlaceboParticipants randomized to receive ALXN2050 or placebo BID on Day 1 through Day 14 in a fasted state. |
| Cohort 5: 120 mg ALXN2050/Placebo | Experimental | Drug: ALXN2050, Drug: PlaceboParticipants randomized to receive a single dose of ALXN2050 or placebo on Day 1 in a fed state. |
| Cohort 6: 240 mg ALXN2050/Placebo | Experimental | Drug: ALXN2050, Drug: PlaceboParticipants randomized to receive a single dose of ALXN2050 or placebo on Day 1 in a fasted state. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Was overtly healthy as determined by medical evaluation including detailed medical history, physical examination, blood pressure and heart rate measurements, 12-lead ECG, and clinical laboratory tests.
- Had a body weight of at least 50 kilograms (kg) and body mass index within the range of 18 to 30 kg/meter squared (inclusive).
- Male participants were eligible to participate if they agreed to abstinence or use of a highly effective method of contraception.
- Female participants must have been of nonchildbearing potential.
Key exclusion criteria (7 listed)
- Had a history or clinically relevant evidence of current cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disorders or conditions capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
- Had a body temperature greater than or equal to 38°Celsius on Day -1 or Day 1, Hour 0; had a history of febrile illness, or other evidence of infection, within 14 days prior to first study drug administration.
- Had a sensitivity to any of the study interventions, or components thereof, or drug or other allergy that contraindicated participation in the study.
- Donated blood or lost more than 500 milliliters of blood within 3 months prior to first study drug administration, or received a blood transfusion or blood products within 6 months prior to first study drug administration.
- Current enrollment or past participation within the last 30 days before study drug administration in any clinical study involving an investigational study intervention or any other type of medical research
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), ACH-5228Powder-in-capsule (PIC). | Drug | Cohort 1: 40 mg ALXN2050/Placebo, Cohort 2: 80 mg ALXN2050/Placebo, Cohort 3: 120 mg ALXN2050/Placebo, Cohort 4: 200 mg ALXN2050/Placebo, Cohort 5: 120 mg ALXN2050/Placebo, Cohort 6: 240 mg ALXN2050/Placebo |
| PlaceboPIC. | Drug | Cohort 1: 40 mg ALXN2050/Placebo, Cohort 2: 80 mg ALXN2050/Placebo, Cohort 3: 120 mg ALXN2050/Placebo, Cohort 4: 200 mg ALXN2050/Placebo, Cohort 5: 120 mg ALXN2050/Placebo, Cohort 6: 240 mg ALXN2050/Placebo |
Primary outcome
Number Of Participants Experiencing Serious Adverse Events
Time frame: Day 1 through Day 42
Number Of Participants Experiencing Grade 3 Or 4 Adverse Events (AEs)
Time frame: Day 1 through Day 42
Number Of Participants Experiencing AEs Leading To Discontinuation From The Study
Time frame: Day 1 through Day 42
Number Of Participants Experiencing Grade 3 Or 4 Laboratory Abnormalities
Time frame: Day 1 through Day 42
Number Of Participants Experiencing Treatment-emergent Vital Signs, Physical Examination Results, And Electrocardiogram (ECG) Abnormalities
Time frame: Day 1 through Day 42
8 secondary outcomes
Maximum Steady-state Plasma Concentration (Cmax,ss) Of Multiple-dose ALXN2050
Time frame: Up to 168 hours postdose
Time To Reach Maximum Steady-state Plasma Concentration (Tmax,ss) Of Multiple-dose ALXN2050
Time frame: Up to 168 hours postdose
Area Under The Plasma Concentration Versus Time Curve Over The Dosing Interval (AUCtau) Of Multiple-dose ALXN2050
Time frame: Up to 168 hours postdose
Maximum Plasma Concentration (Cmax) Of Single-dose ALXN2050
Time frame: Up to 72 hours postdose
Time To Reach Maximum Plasma Concentration (Tmax) Of Single-dose ALXN2050
Time frame: Up to 72 hours postdose
Area Under The Concentration-time Curve Extrapolated To Infinity (AUC0-inf) For Single-dose ALXN2050
Time frame: Up to 72 hours postdose
Alternative Pathway (AP) Activity As Measured By Wieslab Assay
Time frame: Up to 14 days postdose
Plasma Bb Fragment Of Complement Factor B Concentration Over Time
Time frame: Up to 14 days 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 17 Sep 2021.
- Individual participant dataSharing planned: Yes
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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 New Zealand.
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 4 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 17 Sep 2021. 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 New Zealand. 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 Experiencing Serious Adverse Events (time frame: Day 1 through Day 42). The study lists 5 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 17 Sep 2021.