Back to resultsALLN-346 Single Ascending Dose (SAD) Study in Healthy Volunteers (SAD)
Primary Purpose
Hyperuricemia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ALLN-346
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hyperuricemia focused on measuring hyperuricemia, gout, urate oxidase, uric acid
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Medpace Clinical Pharmacology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ALLN-346
Placebo
Arm Description
ALLN-346
Placebo
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Anti-drug antibody assessment of immune response
Development of anti-drug antibodies (total Immunoglobin levels, mg/dL)
Serum level of ALLN-346
Change of serum ALLN-346 level (ng/mL)
Serum ALLN-346 uricase activity level
Change of serum ALLN-346 activity (ng/mL)
Serum uric acid assessment of pharmacodynamic response
Change in serum uric acid concentration (mg/dL)
C-reactive protein (CRP) assessment of inflammation response
Change in CRP blood levels (mg/L)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04236219
Brief Title
ALLN-346 Single Ascending Dose (SAD) Study in Healthy Volunteers
Acronym
SAD
Official Title
A Phase I Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose Study of ALLN-346 (Engineered Urate Oxidase)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
September 2, 2020 (Actual)
Primary Completion Date
November 6, 2020 (Actual)
Study Completion Date
November 6, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allena Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperuricemia
Keywords
hyperuricemia, gout, urate oxidase, uric acid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ALLN-346
Arm Type
Experimental
Arm Description
ALLN-346
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
ALLN-346
Other Intervention Name(s)
Engineered urate oxidase
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Matching placebo capsule
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of treatment emergent adverse events (TEAEs)
Description
Number of participants with treatment emergent adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Anti-drug antibody assessment of immune response
Description
Development of anti-drug antibodies (total Immunoglobin levels, mg/dL)
Time Frame
28 days
Title
Serum level of ALLN-346
Description
Change of serum ALLN-346 level (ng/mL)
Time Frame
48 hours
Title
Serum ALLN-346 uricase activity level
Description
Change of serum ALLN-346 activity (ng/mL)
Time Frame
48 hours
Title
Serum uric acid assessment of pharmacodynamic response
Description
Change in serum uric acid concentration (mg/dL)
Time Frame
48 hours
Title
C-reactive protein (CRP) assessment of inflammation response
Description
Change in CRP blood levels (mg/L)
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Tosone, MS
Organizational Affiliation
Allena Pharmaceuticals, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Medpace Clinical Pharmacology
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
ALLN-346 Single Ascending Dose (SAD) Study in Healthy Volunteers
We'll reach out to this number within 24 hrs