HealthyPhase 1NCT04920370
Study of Subcutaneous and Intravenous ALXN1720 With and Without rHuPH20 in Healthy Subjects
A Phase 1 study testing ALXN1720 SC, ALXN1720 IV and rHuPH20 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, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of ALXN1720 administered subcutaneously (SC) or intravenously (IV). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ALXN1720 SC, ALXN1720 IV and rHuPH20
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Sep 2019to 16 Nov 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body weight within 50 to 90 kilograms (kg), inclusive, and body mass index within the range of 18 to 29.9 kg/meter squared, inclusive.
- Willing to follow protocol-specified contraception guidance while on treatment and for 6 months after the last dose of study treatment.
- Vaccination with tetravalent meningococcal conjugate vaccine and serogroup B meningococcal vaccine.
- No clinically significant or relevant abnormalities as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram, and clinical laboratory evaluation.
- For the cohorts with Japanese participants, parents and grandparents must both be Japanese, and participants must have resided for less than 5 years outside of Japan.
Who cannot join
- Current or recurrent disease that could affect clinical assessments or clinical laboratory evaluations.
- History of complement deficiency or complement activity below the reference range.
- Female participants who are breastfeeding.
- Immunization with a live-attenuated vaccine 28 days prior to dosing on Day 1 or planned vaccination during the course of the study. Immunization with inactivated or recombinant influenza vaccine, or nucleoside-modified messenger ribonucleic acid or recombinant COVID-19 vaccine is permitted.
- Current tobacco smoking, history of illicit drug abuse, or history of significant alcohol abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study of Subcutaneous and Intravenous ALXN1720 With and Without rHuPH20 in Healthy Subjects
This study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of ALXN1720 administered subcutaneously (SC) or intravenously (IV).
Read the detailed description
Participants will be randomized in a 3:1 ratio to receive the active treatment or placebo.
The study will be conducted in healthy adult participants, including participants of Japanese descent.
- Conditions
- Healthy
- Being tested
- ALXN1720 SC, ALXN1720 IV, rHuPH20, Placebo SC, Placebo IV
- Keywords
- ALXN1720, Safety, Pharmacokinetics, Pharmacodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALXN1720 SCDrug
ALXN1720 will be administered via SC route.
ALXN1720 IVDrug
ALXN1720 will be administered via IV route.
rHuPH20Drug
rHuPH20 will be administered via SC route.
Placebo SCDrug
Placebo will be administered via SC route.
Placebo IVDrug
Placebo will be administered via IV route.
| Study group | Role | What they receive |
|---|---|---|
| ALXN1720 Single Dose SC | Experimental | Participants will receive a single dose of ALXN1720 SC. Receives: Drug: ALXN1720 SC |
| ALXN1720 Multiple Dose SC | Experimental | Participants will receive multiple doses of ALXN1720 SC. Receives: Drug: ALXN1720 SC |
| ALXN1720 Single Dose SC + rHuPH20 | Experimental | Participants will receive a single dose of ALXN1720 SC in combination with rHuPH20. Receives: Drug: ALXN1720 SC; Drug: rHuPH20 |
| ALXN1720 Single Dose IV | Experimental | Participants will receive a single dose of ALXN1720 IV. Receives: Drug: ALXN1720 IV |
| Placebo | Placebo comparator | Participants will receive Placebo SC or Placebo IV according to their assigned cohort. Receives: Drug: Placebo SC; Drug: Placebo IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-emergent and Serious Adverse Events (TEAEs, SAEs)
Measured: Up to 176 days following the first day of dosing
Secondary outcomes (14)
Maximum Observed Concentration (Cmax) of ALXN1720 SC, ALXN1720 SC/rHuPH20, and ALXN1720 IV
Measured: Up to 176 days following the first day of dosing
Area Under The Concentration-time Curve (AUC) of ALXN1720 SC, ALXN1720 SC/rHuPH20, and ALXN1720 IV
Measured: Up to 176 days following the first day of dosing
Change from Baseline in Serum Concentrations of Free Complement Component 5 (C5)
Measured: Baseline, 176 days following the first day of dosing
Change from Baseline in Serum Concentrations of Total C5
Measured: Baseline, 176 days following the first day of dosing
Change from Baseline in Ex Vivo Chicken Red Blood Cell (cRBC) Hemolysis Activity
Measured: Baseline, 176 days following the first day of dosing
Incidence of Antidrug Antibodies (ADAs) to ALXN1720
Measured: Up to 176 days following the first day of dosing
Absolute Bioavailability of ALXN1720
The absolute bioavailability for ALXN1720 SC will be defined by the ratio of the geometric means for AUC for ALXN1720 SC over ALXN1720 IV after a single dose.
Measured: Up to 176 days following the first day of dosing
Comparison of Incidence of TEAEs and SAEs Between Healthy Non-Japanese Participants and Participants of Japanese Descent
Measured: Up to 176 days following the first day of dosing
Comparison of Cmax of ALXN1720 SC, ALXN1720 SC/rHuPH20, and ALXN1720 IV Between Healthy Non-Japanese Participants and Participants of Japanese Descent
Measured: Up to 176 days following the first day of dosing
Comparison of AUC of ALXN1720 SC, ALXN1720 SC/rHuPH20, and ALXN1720 IV Between Healthy Non-Japanese Participants and Participants of Japanese Descent
Measured: Up to 176 days following the first day of dosing
Comparison of Change from Baseline in Serum Concentrations of Free C5 Between Healthy Non-Japanese Participants and Participants of Japanese Descent
Measured: Baseline, 176 days following the first day of dosing
Comparison of Change from Baseline in Serum Concentrations of Total C5 Between Healthy Non-Japanese Participants and Participants of Japanese Descent
Measured: Baseline, 176 days following the first day of dosing
Comparison of Change from Baseline in Serum Concentrations in Ex Vivo cRBC Hemolysis Activity Between Healthy Non-Japanese Participants and Participants of Japanese Descent
Measured: Baseline, 176 days following the first day of dosing
Comparison of ADAs to ALXN1720 Between Healthy Non-Japanese Participants and Participants of Japanese Descent
Measured: Up to 176 days following the first day of dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start4 Sep 2019
- Primary completion16 Nov 2021
- Study completion16 Nov 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 97 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
- NCT04920370
- Sponsor's protocol ID
- ALXN1720-HV-101
- Other IDs
- 2018-004500-19, 2018
- Status last verified
- Jan 2022
- First submitted
- 3 Jun 2021
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study of Subcutaneous and Intravenous ALXN1720 With and Without rHuPH20 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04920370
- Acronym / sponsor ID
- ALXN1720-HV-101
- Conditions
- Healthy
- Keywords
- ALXN1720, Safety, Pharmacokinetics, Pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Sep 2019 (actual)
- Primary completion
- 16 Nov 2021 (actual)
- Study completion
- 16 Nov 2021 (actual)
- First posted
- 9 Jun 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 study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of ALXN1720 administered subcutaneously (SC) or intravenously (IV).
Detailed description
Participants will be randomized in a 3:1 ratio to receive the active treatment or placebo.
The study will be conducted in healthy adult participants, including participants of Japanese descent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| ALXN1720 Single Dose SC | Experimental | Drug: ALXN1720 SCParticipants will receive a single dose of ALXN1720 SC. |
| ALXN1720 Multiple Dose SC | Experimental | Drug: ALXN1720 SCParticipants will receive multiple doses of ALXN1720 SC. |
| ALXN1720 Single Dose SC + rHuPH20 | Experimental | Drug: ALXN1720 SC, Drug: rHuPH20Participants will receive a single dose of ALXN1720 SC in combination with rHuPH20. |
| ALXN1720 Single Dose IV | Experimental | Drug: ALXN1720 IVParticipants will receive a single dose of ALXN1720 IV. |
| Placebo | Placebo comparator | Drug: Placebo SC, Drug: Placebo IVParticipants will receive Placebo SC or Placebo IV according to their assigned cohort. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Body weight within 50 to 90 kilograms (kg), inclusive, and body mass index within the range of 18 to 29.9 kg/meter squared, inclusive.
- Willing to follow protocol-specified contraception guidance while on treatment and for 6 months after the last dose of study treatment.
- Vaccination with tetravalent meningococcal conjugate vaccine and serogroup B meningococcal vaccine.
- No clinically significant or relevant abnormalities as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram, and clinical laboratory evaluation.
- For the cohorts with Japanese participants, parents and grandparents must both be Japanese, and participants must have resided for less than 5 years outside of Japan.
Key exclusion criteria (5 listed)
- Current or recurrent disease that could affect clinical assessments or clinical laboratory evaluations.
- History of complement deficiency or complement activity below the reference range.
- Female participants who are breastfeeding.
- Immunization with a live-attenuated vaccine 28 days prior to dosing on Day 1 or planned vaccination during the course of the study. Immunization with inactivated or recombinant influenza vaccine, or nucleoside-modified messenger ribonucleic acid or recombinant COVID-19 vaccine is permitted.
- Current tobacco smoking, history of illicit drug abuse, or history of significant alcohol abuse.
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 |
|---|---|---|
| ALXN1720 SCALXN1720 will be administered via SC route. | Drug | ALXN1720 Multiple Dose SC, ALXN1720 Single Dose SC, ALXN1720 Single Dose SC + rHuPH20 |
| ALXN1720 IVALXN1720 will be administered via IV route. | Drug | ALXN1720 Single Dose IV |
| rHuPH20rHuPH20 will be administered via SC route. | Drug | ALXN1720 Single Dose SC + rHuPH20 |
| Placebo SCPlacebo will be administered via SC route. | Drug | Placebo |
| Placebo IVPlacebo will be administered via IV route. | Drug | Placebo |
Primary outcome
Incidence of Treatment-emergent and Serious Adverse Events (TEAEs, SAEs)
Time frame: Up to 176 days following the first day of dosing
14 secondary outcomes
Maximum Observed Concentration (Cmax) of ALXN1720 SC, ALXN1720 SC/rHuPH20, and ALXN1720 IV
Time frame: Up to 176 days following the first day of dosing
Area Under The Concentration-time Curve (AUC) of ALXN1720 SC, ALXN1720 SC/rHuPH20, and ALXN1720 IV
Time frame: Up to 176 days following the first day of dosing
Change from Baseline in Serum Concentrations of Free Complement Component 5 (C5)
Time frame: Baseline, 176 days following the first day of dosing
Change from Baseline in Serum Concentrations of Total C5
Time frame: Baseline, 176 days following the first day of dosing
Change from Baseline in Ex Vivo Chicken Red Blood Cell (cRBC) Hemolysis Activity
Time frame: Baseline, 176 days following the first day of dosing
Incidence of Antidrug Antibodies (ADAs) to ALXN1720
Time frame: Up to 176 days following the first day of dosing
Absolute Bioavailability of ALXN1720
Time frame: Up to 176 days following the first day of dosing
Comparison of Incidence of TEAEs and SAEs Between Healthy Non-Japanese Participants and Participants of Japanese Descent
Time frame: Up to 176 days following the first day of dosing
Comparison of Cmax of ALXN1720 SC, ALXN1720 SC/rHuPH20, and ALXN1720 IV Between Healthy Non-Japanese Participants and Participants of Japanese Descent
Time frame: Up to 176 days following the first day of dosing
Comparison of AUC of ALXN1720 SC, ALXN1720 SC/rHuPH20, and ALXN1720 IV Between Healthy Non-Japanese Participants and Participants of Japanese Descent
Time frame: Up to 176 days following the first day of dosing
Comparison of Change from Baseline in Serum Concentrations of Free C5 Between Healthy Non-Japanese Participants and Participants of Japanese Descent
Time frame: Baseline, 176 days following the first day of dosing
Comparison of Change from Baseline in Serum Concentrations of Total C5 Between Healthy Non-Japanese Participants and Participants of Japanese Descent
Time frame: Baseline, 176 days following the first day of dosing
Comparison of Change from Baseline in Serum Concentrations in Ex Vivo cRBC Hemolysis Activity Between Healthy Non-Japanese Participants and Participants of Japanese Descent
Time frame: Baseline, 176 days following the first day of dosing
Comparison of ADAs to ALXN1720 Between Healthy Non-Japanese Participants and Participants of Japanese Descent
Time frame: Up to 176 days following the first day of dosing
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 11 Feb 2022.
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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 ALXN1720 SC, ALXN1720 IV and rHuPH20 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 5 inclusion and 5 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 11 Feb 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 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. Some participants in this study may receive a placebo. 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?
Incidence of Treatment-emergent and Serious Adverse Events (TEAEs, SAEs) (time frame: Up to 176 days following the first day of dosing). 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 11 Feb 2022.