Amyotrophic Lateral SclerosisPhase 1/2NCT06726577
TP04HN106 in the Treatment of Patients With Amyotrophic Lateral Sclerosis
A Phase 1/2 study testing TP04HN106 and Saline in people with Amyotrophic Lateral Sclerosis, run by Talengen Institute of Life Sciences, Shenzhen, P.R. China. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- TP04HN106 and Saline
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 4 Jun 2026to Apr 2027
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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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Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
Caifang Ni, 86-13706200115, cir.nicaifang@vip.163.com
About this study
Official 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
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.
Read more
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.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- TP04HN106, Saline
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TP04HN106Drug
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.
SalineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental drug group | Experimental | Not described Receives: Drug: TP04HN106 |
| Placebo group | Placebo comparator | Not described Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amyotrophic Lateral Sclerosis Rating Scale (ALSFRS-R)
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.
Measured: Baseline, 10th week
Secondary outcomes (7)
ALSFRS-R
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.
Measured: Baseline, week 2, 6, 12, 14, 18, 22, and 28
Rasch Global Disability Assessment Scale (ROADS) scores
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
Measured: Baseline, week 2, 6, 10, 12, 14, 18, 22, and 28
FVC%
The change value/rate of FVC% compared to baseline at weeks 2, 6, 10, 12, 14, 18, 22, and 28;
Measured: Basline, weeks 2, 6, 10, 12, 14, 18, 22, and 28
Muscle strength
Changes in muscle strength from baseline as measured by a handheld dynamometer (HHD) at weeks 2, 6, 10, 12, 14, 18, 22, and 28;
Measured: Baseline，week 2, 6, 10, 12, 14, 18, 22, and 28;weeks 2, 6, 10, 12, 14, 18, 22, and 28
Neurofilament light chain level
Change in the levels of Neurofilament light chain (NFL) in the subjects' venous plasma at week 10 and 22
Measured: Baseline，week 10，week 22
CMAP amplitude
Changes in neuromuscular electrophysiological examination (CMAP amplitude measurement of clinically affected area) relative to baseline at week 10 and 22.
Measured: Baseline，week 10，week 22
Incidence of permanent invasive breathing or oxygen assistance/death
Incidence of permanent invasive breathing or oxygen assistance/death during the trial;
Measured: Through study completion, an average of 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start4 Jun 2026
- Primary completionJan 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Talengen Institute of Life Sciences, Shenzhen, P.R. China.
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Soochow University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726577
- Sponsor's protocol ID
- TP04HN106-ALS-IIT
- Status last verified
- Sep 2026
- First submitted
- 2 Dec 2024
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No