NCT06726577
TP04HN106 in the Treatment of Patients With Amyotrophic Lateral Sclerosis
Recruiting · Phase 1, Phase 2 · Talengen Institute of Life Sciences, Shenzhen, P.R. China. · registry updated 2026-10-02
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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....
Inclusion
- 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
- 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;