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ALLN-346 Single Ascending Dose (SAD) Study in Healthy Volunteers

NCT04236219 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-07-23

No results posted yet for this study

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.

Conditions

  • Hyperuricemia

Interventions

DRUG

ALLN-346

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.

DRUG

Placebo

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.

Sponsors & Collaborators

  • Allena Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Christine Tosone, MS · Allena Pharmaceuticals, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-02
Primary Completion
2020-11-06
Completion
2020-11-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04236219 on ClinicalTrials.gov