Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: testing TP04HN106 for Amyotrophic Lateral Sclerosis

This trial adopts a multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment parallel design. This experiment is divided into two groups: the experimental drug group and the dummy treatment (placebo) group.

Official registry: https://clinicaltrials.gov/study/NCT06726577 · Talengen Institute of Life Sciences, Shenzhen, P.R. China. · enrollment listed as 60

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are TP04HN106, or Saline. The registry lists allocation as randomized. This trial adopts a multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment parallel design.

They plan to enroll about 60 people at Suzhou. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial Evaluating the Safety, Efficacy, and Pharmacokinetic Characteristics of TP04HN106 in the Treatment of Patients With Amyotrophic Lateral Sclerosis

Interventions: TP04HN106, Saline

Primary outcome (registry wording): Amyotrophic Lateral Sclerosis Rating Scale (ALSFRS-R)

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Meet the diagnostic criteria for amyotrophic lateral sclerosis (ALS) (Gold Coast Criteria 2020）;
  • Age ≥18 years old, male or female;
  • The amyotrophic lateral sclerosis Function Rating Scale (ALSFRS-R）of pre-visit subjects should be ≥1 score for dyspnea, upright breathing and respiratory dysfunction;
  • Pre-randomly assigned subjects received stable dose of riluzole tablets for ≥7 days, and should maintain the treatment until the last study visit;

Public study contact (from the registry)

Doctor Li, Dr

0086-89290018

jnl@talengen-pharma.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT06726577 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06726577?

Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06726577?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary