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NCT Number: NCT06726577

TP04HN106 in the Treatment of Patients With Amyotrophic Lateral Sclerosis

This trial adopts a multicenter, randomized, double-blind, placebo-controlled parallel design.

This experiment is divided into two groups: the experimental drug group and the placebo group. Successful participants will be randomly assigned to the two groups, with an expected enrollment of 60 participants. There will be 30 participants in the experimental drug group and 30 participants in the placebo group. During the treatment period, the experimental drug group received intravenous injections of 0.5mL/kg TP04HN106 each time; The placebo group received intravenous injections of 0.5mL/kg of saline each time. During the extension period, all subjects received intravenous injection of 0.5mL/kg TP04HN106. In the experiment, all subjects received Liraglutide tablets as the standard baseline treatment.

The subjects who were successfully screened in the experiment were enrolled in sequence, and the safety, tolerability, efficacy, and pharmacokinetic characteristics of the experimental drug were evaluated after administration. The entire trial includes a screening period of 1 week, a treatment period of 12 weeks (including 3 treatment cycles, each treatment cycle of 4 weeks), an extension period of 12 weeks (including 3 treatment cycles, each treatment cycle of 4 weeks), and a follow-up period of 4 weeks. In addition, some subjects underwent a 1-week single dose PK study before the start of the treatment period; In addition, during the first treatment cycle of the treatment period, some subjects were selected for multiple dosing PK studies.

We plan to conduct a single dose PK study among 12 subjects, with 6 subjects in the experimental group and 6 subjects in the control group; Multiple dose PK studies were conducted among 12 subjects, with 6 subjects in the experimental group and 6 sujects in the control group. It is not allowed for the same subject to participate in both single dose and multiple dose PK studies simultaneously.

The 1st to 12th subjects planned to be enrolled in the trial will undergo a single dose PK study. After the first dose, venous blood will be collected from the 12 subjects according to the blood sample collection requirements, and their PK characteristics will be evaluated. The observation period for single dose administration is one week. After completing the final blood sample collection and safety assessment, the subjects enter the treatment period, extension period, and follow-up period.

The 13th to 24th subjects planned to be enrolled in the trial will undergo multiple dose PK studies. These 12 subjects will have their venous blood collected according to the blood sample collection requirements during the first treatment cycle of the treatment period, and their PK characteristics will be evaluated. After completing the treatment period, the subjects will enter the extension period and follow-up period.

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Key information

Conditions

Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

Location status: Recruiting

Location contact

Caifang Ni

CONTACT

[email protected]

86-13706200115

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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-randomized subjects received stable dose of riluzole tablets for ≥7 days, and should maintain the treatment until the last study visit;
  • Voluntarily participate in clinical trials, sign informed consent, and understand and comply with study procedures.

Exclusion criteria

  • The subject is known to be allergic to the investigational drug or its excipients;
  • 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);
  • The subject has a major mental illness or cognitive dysfunction;
  • Patients with a history of secondary or above surgery within one month before the screening period;
  • The subjects participated in other clinical studies within 1 month;
  • The subjects are pregnant or lactating women;
  • Poor compliance or other researchers believe that there are any circumstances that are not suitable for inclusion.

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Treatment and study plan

TP04HN106

Drug

During the treatment period, the experimental drug group received intravenous injections of 0.5mL/kg TP04HN106 each time; During the extension period, all subjects received intravenous injection of 0.5mL/kg TP04HN106.

Saline

Drug

The placebo group received intravenous injections of 0.83mL/kg of saline each time. In the experiment, all subjects received Liraglutide tablets as the standard baseline treatment.

Primary outcomes

  1. Amyotrophic Lateral Sclerosis Rating Scale (ALSFRS-R)

    Time frame: Baseline, 10th week

    The Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R) measures the severity of functional disorders. This scale measures three functional domains, namely medullary function, motor function, and respiratory function. The evaluation will consist of 12 questions, with scores ranging from 0 (non functional) to 4 (fully functional), for a total score of 48, which will indicate the highest level of functionality.

Secondary outcomes

  1. ALSFRS-R

    Time frame: Baseline, week 2, 6, 12, 14, 18, 22, and 28

    The Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R) measures the severity of functional disorders. This scale measures three functional domains, namely medullary function, motor function, and respiratory function. The evaluation will consist of 12 questions, with scores ranging from 0 (non functional) to 4 (fully functional), for a total score of 48, which will indicate the highest level of functionality.

  2. Rasch Global Disability Assessment Scale (ROADS) scores

    Time frame: Baseline, week 2, 6, 10, 12, 14, 18, 22, and 28

    The Rasch Global Disability Assessment Scale (ROADS) scores is a comprehensive functional impairment assessment scale for amyotrophic lateral sclerosis syndrome. This scale consists of 28 items, arranged in order from the easiest action to the most difficult action, with a total score of 56 points

  3. FVC%

    Time frame: Basline, week 6, 10, 12, 14, 18, 22, and 28

    The change value/rate of FVC% compared to baseline at weeks 6, 10, 12, 14, 18, 22, and 28;

  4. Muscle strength

    Time frame: Baseline，week 2, 6, 10, 12, 14, 18, 22, and 28;weeks 2, 6, 10, 12, 14, 18, 22, and 28

    Changes in muscle strength from baseline as measured by a handheld dynamometer (HHD) at weeks 2, 6, 10, 12, 14, 18, 22, and 28;

  5. Neurofilament light chain level

    Time frame: Baseline，week 10，week 22

    Change in the levels of Neurofilament light chain (NFL) in the subjects' venous plasma at week 10 and 22

  6. CMAP amplitude

    Time frame: Baseline，week 10，week 22

    Changes in neuromuscular electrophysiological examination (CMAP amplitude measurement of clinically affected area) relative to baseline at week 10 and 22.

  7. Incidence of permanent invasive breathing or oxygen assistance/death

    Time frame: Through study completion, an average of 28 weeks

    Incidence of permanent invasive breathing or oxygen assistance/death during the trial;

Study contacts

Contact information is provided by the study sponsor or research team.

Doctor Li, Dr

CONTACT

[email protected]

0086-89290018

Sponsors and collaborators

Lead sponsor

Talengen Institute of Life Sciences, Shenzhen, P.R. China.

Other

Collaborators

  • The First Affiliated Hospital of Soochow University

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 10, 2024
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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