Phase 1/2Recruiting
TP04HN106 in the Treatment of Patients With Amyotrophic Lateral Sclerosis
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
- Sponsor
- Talengen Institute of Life Sciences, Shenzhen, P.R. China. (Academic or other)
- Enrolment
- 60 planned
- Conditions
- Amyotrophic Lateral Sclerosis
- Interventions
- TP04HN106; Saline
- Ages
- adults, older adults
- Registry
- NCT06726577
From the registry
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…
Primary outcomes
- Amyotrophic Lateral Sclerosis Rating Scale (ALSFRS-R)