NCT04923282 is a Phase 1 clinical trial of single 1-hour IV infusion of 0.8 mg/kg recAP in Healthy, sponsored by AM-Pharma.

Who is sponsoring NCT04923282?

NCT04923282 is sponsored by AM-Pharma.

What drugs are being tested in NCT04923282?

Interventions in NCT04923282: single 1-hour IV infusion of 0.8 mg/kg recAP, single 1-hour IV infusion of 1.6 mg/kg recAP, single 1-hour IV infusion of 3.2 mg/kg recAP, 1-hour infusions of 1.6 mg/kg recAP on Days 1, 2 and 3, Placebo.

Is NCT04923282 still recruiting?

NCT04923282 is currently completed. Last updated 14 March 2022.

Last reviewed 2022-03-14 · How we verify

NCT04923282

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

Recombinant Human Alkaline Phosphatase in Healthy Japanese Subjects

Completed Phase 1 Last updated 14 March 2022

What this trial tests

Phase 1 trial testing single 1-hour IV infusion of 0.8 mg/kg recAP in Healthy in 34 participants. Completed in 31 December 2021.

Timeline

7 May 2021

Primary endpoint
8 July 2021

31 December 2021

Quick facts

Lead sponsor	AM-Pharma
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	treatment
Enrollment	34
Start date	7 May 2021
Primary completion	8 July 2021
Estimated completion	31 December 2021
Sites	1 location across Japan

Drugs / interventions tested

single 1-hour IV infusion of 0.8 mg/kg recAP — full drug profile →
single 1-hour IV infusion of 1.6 mg/kg recAP — full drug profile →
single 1-hour IV infusion of 3.2 mg/kg recAP — full drug profile →
1-hour infusions of 1.6 mg/kg recAP on Days 1, 2 and 3 — full drug profile →
Placebo

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

AM-Pharma — full company profile →

Who can join

Adults 20 to 55, male only, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Clinical Phase 1 study to investigate the pharmacokinetics and to assess the safety and tolerability of recAP after single and multiple intravenous doses in healthy Japanese subjects.

Publications & conference data

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

Alkaline Phosphatase: An Old Friend as Treatment Target for Cardiovascular and Mineral Bone Disorders in Chronic Kidney Disease.
Haarhaus M, Cianciolo G, Barbuto S, La Manna G, et al · · 2022 · cited 73× · PMID 35631265 · DOI 10.3390/nu14102124

Verify or expand the search:

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Other AM-Pharma trials

Trials by the same sponsor.

NCT06168799 — Ilofotase Alfa for Prevention of Renal Damage After Cardiac Surgery · Phase 2 · completed
NCT05890794 — Pilot Trial of Single Dose Ilofotase Alfa in Hypophosphatasia · Phase 1, PHASE2 · completed
NCT04411472 — (Revival) Study to Investigate the Efficacy and Safety of Alkaline Phosphatase in Patients With Sepsis-Associated AKI · Phase 3 · terminated
NCT02182440 — A Safety, Tolerability, Efficacy and QoL Study of Human recAP in the Treatment of Patients With SA-AKI · Phase 2 · completed

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 NCT04923282 (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 AM-Pharma
Last refreshed: 14 March 2022

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/NCT04923282.

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