Treatment of Amyotrophic Lateral Sclerosis with TP04HN106

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

This study is testing a new drug called TP04HN106 to see if it can help people with ALS feel better and improve their condition.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Talengen Institute of Life Sciences, Shenzhen, P.R. China. (other)
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT06726577 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of the experimental drug TP04HN106 in patients diagnosed with amyotrophic lateral sclerosis (ALS). It employs a multicenter, randomized, double-blind, placebo-controlled design, enrolling 60 participants who will be divided into two groups: one receiving the experimental drug and the other receiving a placebo. Participants will receive intravenous injections of TP04HN106 or saline, along with standard treatment using Liraglutide tablets. The study aims to assess the drug's pharmacokinetics and overall tolerability.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who meet the diagnostic criteria for ALS and have a specific level of respiratory function.

Not a fit: Patients with severe irreversible diseases of the heart, lung, liver, or brain, or those with known allergies to the investigational drug will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with ALS, potentially improving their quality of life.

How similar studies have performed: While this approach is novel for ALS treatment, similar studies targeting other neurodegenerative diseases have shown promising results.

Eligibility criteria

Inclusion Criteria:

1. Meet the diagnostic criteria for amyotrophic lateral sclerosis (ALS) (Gold Coast Criteria 2020）;
2. Age ≥18 years old, male or female;
3. The amyotrophic lateral sclerosis Function Rating Scale (ALSFRS-R）of pre-visit subjects should be ≥1 score for dyspnea, upright breathing and respiratory dysfunction;
4. Pre-randomized subjects received stable dose of riluzole tablets for ≥7 days, and should maintain the treatment until the last study visit;
5. Voluntarily participate in clinical trials, sign informed consent, and understand and comply with study procedures.

Exclusion Criteria:

1. The subject is known to be allergic to the investigational drug or its excipients;
2. The subject has a disease or injury that interferes with functional assessment or threatens life, or is accompanied by a serious irreversible disease of the heart, lung, liver, or brain, or is accompanied by a failure of different organs (for patients with respiratory failure, only patients diagnosed as type I or type II respiratory failure are excluded);
3. The subject has a major mental illness or cognitive dysfunction;
4. Patients with a history of secondary or above surgery within one month before the screening period;
5. The subjects participated in other clinical studies within 1 month;
6. The subjects are pregnant or lactating women;
7. Poor compliance or other researchers believe that there are any circumstances that are not suitable for inclusion.

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Where this trial is running

Suzhou, Jiangsu

• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (RECRUITING)

Study contacts

• Study coordinator: Doctor Li, Dr

Conditions: Amyotrophic Lateral Sclerosis