NCT04829435 (MAD) is a Phase 1 clinical trial of ALLN-346 in Hyperuricemia, sponsored by Allena Pharmaceuticals.

Who is sponsoring NCT04829435?

NCT04829435 is sponsored by Allena Pharmaceuticals.

What drugs are being tested in NCT04829435?

Interventions in NCT04829435: ALLN-346, Placebo.

What condition does NCT04829435 study?

NCT04829435 studies Hyperuricemia, Gout.

Is NCT04829435 still recruiting?

NCT04829435 is currently completed. Last updated 1 July 2021.

Last reviewed 2021-07-01 · How we verify

NCT04829435: MAD

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study 102: Multiple Ascending Dose Study of ALLN-346 (Engineered Urate Oxidase)

Completed Phase 1 Last updated 1 July 2021

What this trial tests

Phase 1 trial testing ALLN-346 in Hyperuricemia in 18 participants. Completed in 1 June 2021.

Timeline

21 April 2021

Primary endpoint
1 June 2021

1 June 2021

Quick facts

Lead sponsor	Allena Pharmaceuticals
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	18
Start date	21 April 2021
Primary completion	1 June 2021
Estimated completion	1 June 2021
Sites	1 location across United States

Drugs / interventions tested

ALLN-346 — full drug profile →
Placebo

Conditions studied

Hyperuricemia — all drugs for Hyperuricemia →
Gout — all drugs for Gout →

Sponsor

Allena Pharmaceuticals — full company profile →

Who can join

Adults 18 to 55, any sex, with Hyperuricemia or Gout. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this Phase I study is to evaluate the safety and tolerability of ALLN-346 in in normal healthy volunteers, in an ascending dose design. ALLN-346 is an (oral) enzyme that specifically degrades urate in the intestinal tract.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Review of Urate-Lowering Therapeutics: From the Past to the Future.
Jenkins C, Hwang JH, Kopp JB, Winkler CA, et al · · 2022 · cited 38× · PMID 36081938 · DOI 10.3389/fphar.2022.925219

Verify or expand the search:

Other trials of ALLN-346

Trials testing the same drug.

NCT04987294 — Phase IIa Study of ALLN-346 (Engineered Urate Oxidase) in Subjects With Hyperuricemia, Gout and Chronic Kidney Disease · Phase 2 · terminated
NCT04987242 — An Inpatient Study of ALLN-346 (Engineered Urate Oxidase) in Hyperuricemic Subjects (Study 201) · Phase 2 · completed
NCT04236219 — ALLN-346 Single Ascending Dose (SAD) Study in Healthy Volunteers · Phase 1 · completed

Other recruiting trials for Hyperuricemia

Currently open trials in the same condition.

NCT07144332 — This Study is to Estimate the Efficacy of Hemodialysis Alone for Uric Acid Clearance in Patients on Hemodialysis. In Ord · recruiting
NCT07400549 — Prospective Exploratory Study on the Comprehensive Application Effectiveness of Exercise Prescription Decision Support T · NA · recruiting
NCT06859073 — A Research Study to Evaluate the Safety of NNC4004-0002 When Given to Participants With Asymptomatic Hyperuricemia · Phase 1 · recruiting
NCT06463561 — CPAP Effect on Lipid Profile and Hyperuricemia in Patients With Dyslipidemia and Moderate-severe Obstructive Sleep Apnea · Phase 4 · recruiting
NCT06729853 — PK and Safety Evaluation Study of SAP-001 in Adult Subjects With Normal and Impaired Renal Function · Phase 1, PHASE2 · active not recruiting

Other Allena Pharmaceuticals trials

Trials by the same sponsor.

NCT04987294 — Phase IIa Study of ALLN-346 (Engineered Urate Oxidase) in Subjects With Hyperuricemia, Gout and Chronic Kidney Disease · Phase 2 · terminated
NCT05168683 — Scintigraphy Study in Healthy Volunteers to Characterize the Performance of ALLN-346 Tablets · Phase 1 · completed
NCT04987242 — An Inpatient Study of ALLN-346 (Engineered Urate Oxidase) in Hyperuricemic Subjects (Study 201) · Phase 2 · completed
NCT04236219 — ALLN-346 Single Ascending Dose (SAD) Study in Healthy Volunteers · Phase 1 · completed
NCT03847090 — Establishing the Safety and Efficacy of Reloxaliase in Patients With Enteric Hyperoxaluria · Phase 3 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04829435 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Allena Pharmaceuticals
Last refreshed: 1 July 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04829435.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing