HyperuricemiaPhase 1SADNCT04236219
ALLN-346 Single Ascending Dose (SAD) Study in Healthy Volunteers
A Phase 1 study testing ALLN-346 in people with Hyperuricemia, run by Allena Pharmaceuticals at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety of ALLN-346 in healthy volunteers, in this first in human, single ascending dose study. ALLN-346 is an enzyme that degrades urate in the gastrointestinal tract. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperuricemia
- What is being tested?
- ALLN-346
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2020to 6 Nov 2020
- 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
- Signed informed consent form
- Incapable of pregnancy, not nursing, and agrees to use an effective method of contraception; males subjects must agree to abstain from sperm donation
- Good general health as determined by medical history and physical examination
- Normal clinical laboratory test results and ECG
Who cannot join
- Presence or history of any significant cardiovascular, gastrointestinal, hepatic, renal, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurological, psychiatric disease or history of hyperuricemia
- Any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines
- Positive screen results for drugs of abuse, alcohol, or cotinine or recent history of drug or alcohol abuse
- Clinically significant abnormal findings on physical examination, vital signs or on electrocardiogram (ECG)
- Positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) antibody
- Received treatment with or exposure to an Investigational drug or device within 30 days prior to or during Screening
- Per Investigator judgment, is not an ideal clinical study candidate
Trial locations and contacts
1 site in 1 country.
United States1 site
Medpace Clinical Pharmacology
Cincinnati, Ohio, 45227
About this study
Official title: A Phase I Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose Study of ALLN-346 (Engineered Urate Oxidase)
The purpose of this study is to evaluate the safety of ALLN-346 in healthy volunteers, in this first in human, single ascending dose study. ALLN-346 is an enzyme that degrades urate in the gastrointestinal tract.
Read the detailed description
This is a Phase I, randomized, double-blind, placebo-controlled single ascending dose study of orally administered ALLN-346. The study will evaluate the safety and tolerability, inflammation and immunogenicity, pharmacokinetics and pharmacodynamics of ALLN-346 in healthy volunteers. The study consists of a Screening Period, a Treatment Period of 3 days, which includes 1 single day of dosing and 3 days of in-house observation, and a safety Follow-up Period through Day 28 following dosing.
- Conditions
- Hyperuricemia
- Being tested
- ALLN-346, Placebo
- Keywords
- hyperuricemia, gout, urate oxidase, uric acid
- Medical subject headings
- Hyperuricemia, Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALLN-346Drug
Also called Engineered urate oxidase
ALLN-346 is novel urate oxidase provided as capsules for oral administration. Single ascending doses within 3 sequential cohorts: Cohort A - 3 capsules administered once, Cohort B - 6 capsules administered once and Cohort C - 12 capsules administered as 6 capsules twice on 1 day.
PlaceboDrug
Also called Matching placebo capsule
Matching placebo capsules for oral administration. Single ascending doses within 3 sequential cohorts: Cohort A - 3 capsules administered once, Cohort B - 6 capsules administered once and Cohort C - 12 capsules administered as 6 capsules twice on 1 day.
| Study group | Role | What they receive |
|---|---|---|
| ALLN-346 | Experimental | ALLN-346 Receives: Drug: ALLN-346 |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events (TEAEs)
Number of participants with treatment emergent adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: 28 days
Secondary outcomes (5)
Anti-drug antibody assessment of immune response
Development of anti-drug antibodies (total Immunoglobin levels, mg/dL)
Measured: 28 days
Serum level of ALLN-346
Change of serum ALLN-346 level (ng/mL)
Measured: 48 hours
Serum ALLN-346 uricase activity level
Change of serum ALLN-346 activity (ng/mL)
Measured: 48 hours
Serum uric acid assessment of pharmacodynamic response
Change in serum uric acid concentration (mg/dL)
Measured: 48 hours
C-reactive protein (CRP) assessment of inflammation response
Change in CRP blood levels (mg/L)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start2 Sep 2020
- Primary completion6 Nov 2020
- Study completion6 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperuricemiaStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allena Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christine Tosone, MS, Study director, Allena Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04236219
- Sponsor's protocol ID
- ALLN-346-101
- Acronym
- SAD
- Status last verified
- Jun 2020
- First submitted
- 14 Jan 2020
- Last updated
- 23 Jul 2021
- 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 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose Study of ALLN-346 (Engineered Urate Oxidase)
- ClinicalTrials.gov ID
- NCT04236219
- Acronym / sponsor ID
- SAD / ALLN-346-101
- Conditions
- Hyperuricemia
- Keywords
- hyperuricemia, gout, urate oxidase, uric acid
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Allena PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 6 Nov 2020 (actual)
- Study completion
- 6 Nov 2020 (actual)
- First posted
- 22 Jan 2020 (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.
The purpose of this study is to evaluate the safety of ALLN-346 in healthy volunteers, in this first in human, single ascending dose study. ALLN-346 is an enzyme that degrades urate in the gastrointestinal tract.
Detailed description
This is a Phase I, randomized, double-blind, placebo-controlled single ascending dose study of orally administered ALLN-346. The study will evaluate the safety and tolerability, inflammation and immunogenicity, pharmacokinetics and pharmacodynamics of ALLN-346 in healthy volunteers. The study consists of a Screening Period, a Treatment Period of 3 days, which includes 1 single day of dosing and 3 days of in-house observation, and a safety Follow-up Period through Day 28 following dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALLN-346 | Experimental | Drug: ALLN-346ALLN-346 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Signed informed consent form
- Incapable of pregnancy, not nursing, and agrees to use an effective method of contraception; males subjects must agree to abstain from sperm donation
- Good general health as determined by medical history and physical examination
- Normal clinical laboratory test results and ECG
Key exclusion criteria (7 listed)
- Presence or history of any significant cardiovascular, gastrointestinal, hepatic, renal, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurological, psychiatric disease or history of hyperuricemia
- Any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines
- Positive screen results for drugs of abuse, alcohol, or cotinine or recent history of drug or alcohol abuse
- Clinically significant abnormal findings on physical examination, vital signs or on electrocardiogram (ECG)
- Positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) antibody
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 |
|---|---|---|
| ALLN-346Also: Engineered urate oxidaseALLN-346 is novel urate oxidase provided as capsules for oral administration. Single ascending doses within 3 sequential cohorts: Cohort A - 3 capsules administered once, Cohort B - 6 capsules administered once and Cohort C - 12 capsules administered as 6 capsules twice on 1 day. | Drug | ALLN-346 |
| PlaceboAlso: Matching placebo capsuleMatching placebo capsules for oral administration. Single ascending doses within 3 sequential cohorts: Cohort A - 3 capsules administered once, Cohort B - 6 capsules administered once and Cohort C - 12 capsules administered as 6 capsules twice on 1 day. | Drug | Placebo |
Primary outcome
Incidence of treatment emergent adverse events (TEAEs)
Time frame: 28 days
Number of participants with treatment emergent adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
5 secondary outcomes
Anti-drug antibody assessment of immune response
Time frame: 28 days
Serum level of ALLN-346
Time frame: 48 hours
Serum ALLN-346 uricase activity level
Time frame: 48 hours
Serum uric acid assessment of pharmacodynamic response
Time frame: 48 hours
C-reactive protein (CRP) assessment of inflammation response
Time frame: 48 hours
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 23 Jul 2021.
- 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.
Christine Tosone, MS study director
Allena Pharmaceuticals, Inc
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 ALLN-346 in people with Hyperuricemia, run by Allena Pharmaceuticals 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 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 23 Jul 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 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. 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 adverse events (TEAEs) (time frame: 28 days). 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 23 Jul 2021.