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NCT04209179 · ClinicalTrials.gov registry record · Phase 1

A Clinical Study Investigating the Safety, Tolerability, PK and PD of PCO371 in Patients With Hypoparathyroidism

A Phase 1 study, sponsored by Chugai Pharmaceutical.

Terminated
Registry status
Phase 1
Development phase
5
Enrollment target

NCT04209179: Clinical Trial Phase 1 study, sponsored by Chugai Pharmaceutical.

NCT04209179 is a Phase 1 study that was terminated before completion, run by Chugai Pharmaceutical. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04209179, a Phase 1 study, was terminated before completion, sponsored by Chugai Pharmaceutical.

TERMINATED
Registry status
Phase 1
Development phase
5 participants
Enrollment target

Study Summary

This is a multi-center, placebo-controlled, randomized, double-blind, multiple-ascending dose study in patients with hypoparathyroidism. The total duration of study medication treatment will be 13 weeks and includes a Fixed-Dose Treatment period and a Dose Titration Treatment period. The Fixed-Dose Treatment period consists of multiple daily dosing at a fixed dose level. Once patients have completed the Fixed-Dose Treatment period, patients will enter the Dose Titration Treatment period where PCO371 (or placebo), oral calcium and oral active vitamin D can each be titrated according to the patient's albumin-corrected serum calcium level.

Primary Outcome

Treatment-emergent adverse events (TEAEs) will be assessed including the number and rate of TEAEs.

Interventions

  • DRUG Placebo
  • DRUG PCO371

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2020-07-23
Est. Completion 2021-05-25
Phase Phase 1
Chugai Pharmaceutical

17 total trials

Why NCT04209179 stopped before completion

NCT04209179 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT04209179 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04209179 about?

NCT04209179 is a clinical study titled "A Clinical Study Investigating the Safety, Tolerability, PK and PD of PCO371 in Patients With Hypoparathyroidism". This is a multi-center, placebo-controlled, randomized, double-blind, multiple-ascending dose study in patients with hypoparathyroidism. The total duration of study medication treatment will be 13 weeks and includes a Fixed-Dose Treatment period and a Dose Titration Treatment period. The Fixed-Dose...

What is the current status of trial NCT04209179?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2020-07-23. Estimated completion is 2021-05-25.

What interventions are being tested in trial NCT04209179?

The interventions under investigation include: Placebo (DRUG), PCO371 (DRUG).

Who is sponsoring clinical trial NCT04209179?

This trial is sponsored by Chugai Pharmaceutical, which has 17 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04209179's enrollment target sits among peer trials

5 1989th of 2000 higher than 6 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04209179, the US trial registry maintained by the National Library of Medicine. NCT04209179 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.