Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 65 Years|
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|C Tosone, MS, RAC|
|Principal Investigator Affiliation||Allena Pharmceuticals|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
This is a Phase II, 7-day, randomized, double-blind, placebo-controlled study of orally administered ALLN-346 in subjects with hyperuricemia. Study will take place at a clinical pharmacology unit (CPU). The study will have two Parts with Part 1 administering the target dose and subject continuing Part 2 to explore a lower dose response. The study will evaluate safety, tolerability, pharmacokinetics (lack of absorption) and pharmacodynamics of ALLN-346.
Experimental: ALLN-346 (Engineered Urate Oxidase)
ALLN-346 is novel urate oxidase provided as capsules for oral administration. Two doses may be evaluated under two Study Parts: Part 1 (5 capsules thrice daily (TID) for a total of 15 capsules per day) will be evaluated for 7 days; Part 2 (3 capsules thrice daily (TID) for a total of 9 capsules per day) will be evaluated for 7 days
Placebo Comparator: Placebo
Matching placebo capsules for oral administration. Two doses may be evaluated under two Study Parts: Part 1 (5 capsules thrice daily (TID) for a total of 15 capsules per day) will be evaluated for 7 days; Part 2 (3 capsules thrice daily (TID) for a total of 9 capsules per day) will be evaluated for 7 days
Drug: - ALLN-346
ALLN-346 (Engineered Urate Oxidase) is an orally administered, novel urate oxidase; provided as capsules for oral administration
Drug: - Placebo
Matched placebo capsules are similar in weight and appearance to the ALLN-346 capsules
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.