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Amyotrophic Lateral Sclerosis (ALS)Phase 1FHND1002-ⅠNCT06782958

Safety, Tolerability, and Pharmacokinetics of FHND1002 Granules in Healthy Adults

A Phase 1 study testing 50mg FHND1002, 100mg FHND1002 and 150 mg FHND1002 in people with Amyotrophic Lateral Sclerosis (ALS), run by Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd. at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of FHND1002 granules in healthy adult volunteers. The study will also assess how a high-fat meal affects the PK characteristics of FHND1002. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Amyotrophic Lateral Sclerosis (ALS)
What is being tested?
50mg FHND1002, 100mg FHND1002 and 150 mg FHND1002
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
1 siteChina
Study dates
5 Jul 2024to 5 Jun 2025
Phase
Phase 1
Are there results?
Not yet: the study is under way

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 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Aged ≥18 and ≤45 years, regardless of gender.
  • Male volunteers weigh ≥50 kg, and female volunteers weigh ≥45 kg, with a body mass index (BMI) between 19.0 and 26.0 kg/m² (inclusive).
  • Medical history, physical examination, laboratory tests, and other assessments are normal or clinically insignificant, as determined by the investigator.
  • Volunteers have no plans for pregnancy and voluntarily agree to use effective non-drug contraceptive measures (e.g., complete abstinence, condoms, sterilization) throughout the study and for three months after the last dose, with no plans for sperm or egg donation.
  • Volunteers agree to comply with all study procedures and follow-up schedules and provide written informed consent.

Who cannot join

  • History or presence of gastrointestinal, renal, hepatic, pulmonary, neurological, hematological, endocrine, oncological, immunological, psychiatric, or cardiovascular diseases that, in the investigator's opinion, may affect the safety of the volunteer or study results.
  • History of severe allergies (e.g., angioedema or anaphylactic shock), hypersensitivity (e.g., to pollen or two or more drugs/foods), or known allergy to any components or excipients of the investigational drug.
  • Use of any drugs that inhibit or induce hepatic drug metabolism (e.g., barbiturates, carbamazepine, phenytoin, corticosteroids) within 28 days before screening.
  • Difficulty swallowing or a history of gastrointestinal diseases affecting drug absorption, digestive system surgeries (except for appendectomy, hemorrhoidectomy, or inguinal hernia repair), or known factors affecting pharmacokinetics.
  • Underwent surgery within six months prior to screening or had surgery affecting drug absorption, distribution, metabolism, or excretion, as determined to be clinically significant by the investigator; or plans to undergo surgery during the study period.
  • History of drug abuse, drug dependence, or a positive drug abuse screening result.
Show all 20Show fewer
  • Use of any prescription drugs, over-the-counter drugs, herbal medicines, or vitamins within 14 days prior to screening or within five half-lives of the drug before the first dose of the study drug (unless deemed irrelevant by the investigator).
  • Participation in another clinical trial with drug administration within three months prior to the first dose of the study drug.
  • Abnormal results in vital signs, electrocardiograms, ultrasounds, chest X-rays, or laboratory tests (e.g., blood routine, urinalysis, coagulation, blood biochemistry) deemed clinically significant by the investigator.
  • Blood donation or other causes of blood loss exceeding 400 mL within three months prior to screening (excluding physiological blood loss in females).
  • Difficulty with venous blood collection or a history of needle or blood phobia.
  • Frequent alcohol consumption within three months prior to screening (defined as more than 14 units of alcohol per week, where 1 unit = 360 mL of beer, 45 mL of spirits with 40% alcohol, or 150 mL of wine), a positive alcohol breath test result, or inability to abstain from alcohol during the study.
  • Vaccination within one month prior to the first dose or planned vaccination during the study or within one month after the study.
  • Smoking more than five cigarettes per day within three months prior to screening or inability to abstain from tobacco use during the study.
  • Excessive consumption of tea, coffee, or caffeine-containing beverages (more than 8 cups per day, where 1 cup = 250 mL) within three months prior to screening, consumption of specific foods (e.g., dragon fruit, mango, grapefruit) within 14 days prior to screening, or unwillingness to avoid caffeine-containing foods and beverages (e.g., tea, coffee, chocolate, cocoa), grapefruit products, or strenuous activities that may affect drug absorption, metabolism, or excretion during the study.
  • Positive serological results for HBsAg, anti-HCV, anti-HIV, or TP-Ab at screening.
  • Pregnant or breastfeeding female volunteers, or positive serum pregnancy test results.
  • Male volunteers (or their partners) or female volunteers with plans for conception during the study period or within three months after study completion, or unwillingness to use non-drug contraceptive measures (e.g., complete abstinence, condoms, sterilization) during the study.
  • Volunteers with specific dietary requirements (e.g., lactose intolerance) or unwillingness to adhere to the standardized diet provided during the study.
  • Any other condition or factor that, in the investigator's judgment, renders the volunteer unsuitable for participation in the clinical trial.

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

  • The first hospital of Lanzhou University

    Lanzhou, Gansu, 730013

Other trials in China

About this study

Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of FHND1002 Granules After Single and Multiple Doses in Healthy Adult Volunteers

The goal of this clinical trial is to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of FHND1002 granules in healthy adult volunteers. The study will also assess how a high-fat meal affects the PK characteristics of FHND1002.

The main questions this study aims to answer are:

Read more

What are the safety and tolerability of FHND1002 granules when administered as single or multiple doses? What are the PK parameters of FHND1002, and what metabolites can be identified in humans?

Participants will:

Take FHND1002 granules or a placebo once daily, either as a single dose or for 7 consecutive days.

Attend regular clinic visits for checkups, tests, and blood sample collection. Undergo assessments, including monitoring for adverse events, physical exams, vital signs, ECGs, and laboratory tests.

Read the detailed description

This study aims to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of FHND1002 granules in healthy adult volunteers. The study is divided into two parts: a single ascending dose (SAD) phase and a multiple ascending dose (MAD) phase, with an additional evaluation of the effect of a high-fat meal on the PK characteristics of FHND1002.

The primary objectives of this study are:

To assess the safety and tolerability of FHND1002 granules following single and multiple doses in healthy volunteers.

To evaluate the impact of a high-fat meal on the PK profile of FHND1002 granules after a single oral dose.

The secondary objectives include:

To characterize the pharmacokinetic parameters of FHND1002 granules in healthy volunteers.

To identify and conduct preliminary research on drug metabolites in humans. This single-center, randomized, double-blind, placebo-controlled, single and multiple ascending dose Phase I clinical trial involves healthy adult volunteers. Based on preclinical pharmacodynamic, pharmacokinetic, and toxicological studies, as well as the formulation specifications of FHND1002 (25 mg and 100 mg), the maximum recommended starting dose for humans is set at 50 mg.

In the SAD phase, five dose groups (50 mg, 100 mg, 150 mg, 200 mg, and 250 mg) will be included, with 8 participants in each group (6 receiving FHND1002 and 2 receiving a placebo). Additionally, a food effect cohort (100 mg) will include 16 participants (14 receiving FHND1002 and 2 receiving a placebo), split into two groups to evaluate the impact of food under fasting and postprandial conditions.

In the MAD phase, three dose groups (100 mg, 150 mg, and 200 mg) will be included, with 8 participants per group (6 receiving FHND1002 and 2 receiving a placebo). Participants will receive FHND1002 or placebo once daily under fasting conditions for 7 consecutive days.

Throughout the study, participants will undergo regular assessments, including blood sample collection for PK analysis, adverse event (AE) monitoring, and evaluations such as physical exams, vital signs, ECGs, and laboratory tests. This study is expected to provide important data on the safety, tolerability, and pharmacokinetics of FHND1002, contributing to its further clinical development.

Being tested
50mg FHND1002, 100mg FHND1002, 150 mg FHND1002, 200 mg FHND1002（fasting）, 250mg FHND1002
Keywords
FHND1002, Amyotrophic Lateral Sclerosis(ALS)
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.

  • 50mg FHND1002Drug

    Participants will receive a daily oral dose of FHND1002 granules (50 mg) ,administered in the morning after fasting for at least 10 hours. The dose will be taken with 240 mL of water.

  • 100mg FHND1002Drug

    Participants will receive a daily oral dose of FHND1002 granules (100 mg) , administered in the morning after fasting for at least 10 hours. The dose will be taken with 240 mL of water.

  • 150 mg FHND1002Drug

    Participants will receive a daily oral dose of FHND1002 granules (150 mg), administered in the morning after fasting for at least 10 hours. The dose will be taken with 240 mL of water.

  • 200 mg FHND1002（fasting）Drug

    Participants will receive a daily oral dose of FHND1002 granules (200 mg), administered in the morning after fasting for at least 10 hours. The dose will be taken with 240 mL of water.

  • 250mg FHND1002Drug

    Participants will receive a daily oral dose of FHND1002 granules (250 mg), administered in the morning after fasting for at least 10 hours. The dose will be taken with 240 mL of water.

  • 200mg FHND1002(postprandial)Drug

    Participants will receive a one-time dose (200 mg) under postprandial conditions

Study groups in NCT06782958
Study groupRoleWhat they receive
Single doseExperimentalParticipants will receive a one-time dose (50 mg, 100 mg, 150 mg, 200 mg, or 250 mg) under fasting conditions or with a high-fat meal (for the 200 mg group).
Receives: Drug: 50mg FHND1002; Drug: 100mg FHND1002; Drug: 150 mg FHND1002; Drug: 200 mg FHND1002（fasting）; Drug: 250mg FHND1002; Drug: 200mg FHND1002(postprandial)
Multiple doseExperimentalParticipants will receive daily doses (100 mg, 150 mg, or 200 mg) for 7 consecutive days under fasting conditions.
Receives: Drug: 100mg FHND1002; Drug: 150 mg FHND1002; Drug: 200 mg FHND1002（fasting）
PlaceboPlacebo comparatorIn the SAD phase, five dose groups (50 mg, 100 mg, 150 mg, 200 mg, and 250 mg) will be included, with 8 participants in each group (6 receiving FHND1002 and 2 receiving a placebo). Additionally, a food effect cohort (100 mg) will include 16 participants (14 receiving FHND1002 and 2 receiving a placebo), split into two groups to evaluate the impact of food under fasting and postprandial conditions. In the MAD phase, three dose groups (100 mg, 150 mg, and 200 mg) will be included, with 8 participants per group (6 receiving FHND1002 and 2 receiving a placebo). Participants will receive FHND1002 or placebo once daily under fasting conditions for 7 consecutive days.
Receives: Drug: 50mg FHND1002; Drug: 100mg FHND1002; Drug: 150 mg FHND1002; Drug: 200 mg FHND1002（fasting）; Drug: 250mg FHND1002; Drug: 200mg FHND1002(postprandial)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peak Plasma Concentration (Cmax)

    This outcome measures the maximum observed plasma concentration of FHND1002 and its metabolites after single and multiple doses.

    Measured: 4 weeks

  2. Time to Peak Plasma Concentration (Tmax)

    This outcome evaluates the time required to reach maximum plasma concentration of FHND1002 and its metabolites.

    Measured: 4 weeks

  3. Area Under the Curve from 0 to the Last Quantifiable Time Point (AUClast)

    AUClast means Area Under the Concentration-Time Curve from 0 to the Last Quantifiable Time Point . This outcome assesses the total drug exposure up to the last measurable plasma concentration after single and multiple doses of FHND1002.

    Measured: 4 weeks

  4. Area Under the Curve Over the Dosing Interval (AUCτ)

    This outcome evaluates drug exposure during the dosing interval at steady state. τ means the dosing intervals.

    Measured: 4 weeks

  5. Trough Concentration (Cmin)

    The parameter is for multiple dose study. This outcome measures the minimum plasma concentration of FHND1002 and its metabolites before the next dose.

    Measured: 4 weeks

  6. Average Plasma Concentration (Cavg)

    The parameter is for multiple dose study. This outcome evaluates the average plasma concentration of FHND1002 during the dosing interval at steady state.

    Measured: 4 weeks

  7. Accumulation Ratio (Rac)

    Accumulation Ratio (Rac) is for Cmax and AUCτ. The outcome evaluates the accumulation of FHND1002 after multiple doses, calculated as the ratio of steady-state to single-dose parameters (e.g., Rac_Cmax, Rac_AUCτ).

    Measured: 4 weeks

  8. Elimination Half-life (t1/2)

    Elimination Half-life (t1/2) of FHND1002 assesses the time required for the plasma concentration of FHND1002 to decrease by half during the elimination phase.

    Measured: 4 weeks

  9. Area Under the Curve from 0 to Infinity (AUC0-inf)

    This outcome evaluates the total drug exposure from the time of dosing extrapolated to infinity for FHND1002 and its metabolites.

    Measured: 4 weeks

  10. Incidence of Adverse Events(AEs)

    This endpoint evaluates the safety of FHND1002 by monitoring the incidence of adverse events (AEs)

    Measured: 7 weeks

  11. Incidence of Adverse Drug Reactions (ADRs)

    This endpoint evaluates the safety of FHND1002 by monitoring the incidence of adverse drug reactions (ADRs),

    Measured: 7 weeks

Secondary outcomes (3)

  1. Coefficient of Variation (DF) of Pharmacokinetic Parameter

    This outcome assesses the variability in pharmacokinetic parameters such as Cmax and AUCτ to understand inter- and intra-subject variability.

    Measured: 4 weeks

  2. Apparent Clearance (CL/F)

    This outcome evaluates the rate of drug clearance from the plasma after oral administration of FHND1002.

    Measured: 4 weeks

  3. Apparent Volume of Distribution (Vz/F)

    This outcome assesses the apparent volume of distribution of FHND1002 following oral administration, providing an estimate of drug distribution in the body.

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2025
  2. Study start5 Jul 2024
  3. Primary completion3 Mar 2025 (estimated)
  4. Study completion5 Jun 2025 (estimated)

Resources

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06782958
Sponsor's protocol ID
FHND1002-I-01
Acronym
FHND1002-Ⅰ
Status last verified
Jan 2025
First submitted
14 Jan 2025
Last updated
20 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Due to privacy and confidentiality concerns, individual participant data (IPD) will not be shared. The data contains sensitive health information that is protected by regulations, and sharing it may compromise participant confidentiality.

Publications

  • Yu CH, Davidson S, Harapas CR, Hilton JB, Mlodzianoski MJ, Laohamonthonkul P, Louis C, Low RRJ, Moecking J, De Nardo D, Balka KR, Calleja DJ, Moghaddas F, Ni E, McLean CA, Samson AL, Tyebji S, Tonkin CJ, Bye CR, Turner BJ, Pepin G, Gantier MP, Rogers KL, McArthur K, Crouch PJ, Masters SL. TDP-43 Triggers Mitochondrial DNA Release via mPTP to Activate cGAS/STING in ALS. Cell. 2020 Oct 29;183(3):636-649.e18. doi: 10.1016/j.cell.2020.09.020. Epub 2020 Oct 7.

    PubMed 33031745

  • Watanabe H, Atsuta N, Hirakawa A, Nakamura R, Nakatochi M, Ishigaki S, Iida A, Ikegawa S, Kubo M, Yokoi D, Watanabe H, Ito M, Katsuno M, Izumi Y, Morita M, Kanai K, Taniguchi A, Aiba I, Abe K, Mizoguchi K, Oda M, Kano O, Okamoto K, Kuwabara S, Hasegawa K, Imai T, Kawata A, Aoki M, Tsuji S, Nakashima K, Kaji R, Sobue G. A rapid functional decline type of amyotrophic lateral sclerosis is linked to low expression of TTN. J Neurol Neurosurg Psychiatry. 2016 Aug;87(8):851-8. doi: 10.1136/jnnp-2015-311541. Epub 2016 Jan 8.

    PubMed 26746183

  • Xu L, Liu T, Liu L, Yao X, Chen L, Fan D, Zhan S, Wang S. Global variation in prevalence and incidence of amyotrophic lateral sclerosis: a systematic review and meta-analysis. J Neurol. 2020 Apr;267(4):944-953. doi: 10.1007/s00415-019-09652-y. Epub 2019 Dec 3.

    PubMed 31797084

  • Zhang J, Northoff G. Author Correction: Beyond noise to function: reframing the global brain activity and its dynamic topography. Commun Biol. 2022 Dec 21;5(1):1397. doi: 10.1038/s42003-022-04379-5. No abstract available.

    PubMed 36543877

  • Baughn MW, Melamed Z, Lopez-Erauskin J, Beccari MS, Ling K, Zuberi A, Presa M, Gonzalo-Gil E, Maimon R, Vazquez-Sanchez S, Chaturvedi S, Bravo-Hernandez M, Taupin V, Moore S, Artates JW, Acks E, Ndayambaje IS, Agra de Almeida Quadros AR, Jafar-Nejad P, Rigo F, Bennett CF, Lutz C, Lagier-Tourenne C, Cleveland DW. Mechanism of STMN2 cryptic splice-polyadenylation and its correction for TDP-43 proteinopathies. Science. 2023 Mar 17;379(6637):1140-1149. doi: 10.1126/science.abq5622. Epub 2023 Mar 16.

    PubMed 36927019

  • Fang MY, Markmiller S, Vu AQ, Javaherian A, Dowdle WE, Jolivet P, Bushway PJ, Castello NA, Baral A, Chan MY, Linsley JW, Linsley D, Mercola M, Finkbeiner S, Lecuyer E, Lewcock JW, Yeo GW. Small-Molecule Modulation of TDP-43 Recruitment to Stress Granules Prevents Persistent TDP-43 Accumulation in ALS/FTD. Neuron. 2019 Sep 4;103(5):802-819.e11. doi: 10.1016/j.neuron.2019.05.048. Epub 2019 Jul 1.

    PubMed 31272829

  • Piol D, Robberechts T, Da Cruz S. Lost in local translation: TDP-43 and FUS in axonal/neuromuscular junction maintenance and dysregulation in amyotrophic lateral sclerosis. Neuron. 2023 May 3;111(9):1355-1380. doi: 10.1016/j.neuron.2023.02.028. Epub 2023 Mar 23.

    PubMed 36963381

  • Mead RJ, Shan N, Reiser HJ, Marshall F, Shaw PJ. Amyotrophic lateral sclerosis: a neurodegenerative disorder poised for successful therapeutic translation. Nat Rev Drug Discov. 2023 Mar;22(3):185-212. doi: 10.1038/s41573-022-00612-2. Epub 2022 Dec 21.

    PubMed 36543887

  • Sheridan C. Unprecedented blood biomarker enables ALS drug approval. Nat Biotechnol. 2023 Jul;41(7):886-888. doi: 10.1038/s41587-023-01862-0. No abstract available.

    PubMed 37386297

  • Mullard A. ALS antisense drug falters in phase III. Nat Rev Drug Discov. 2021 Dec;20(12):883-885. doi: 10.1038/d41573-021-00181-w. No abstract available.

    PubMed 34716445

  • Todd TW, Petrucelli L. Modelling amyotrophic lateral sclerosis in rodents. Nat Rev Neurosci. 2022 Apr;23(4):231-251. doi: 10.1038/s41583-022-00564-x. Epub 2022 Mar 8.

    PubMed 35260846

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 50mg FHND1002, 100mg FHND1002 and 150 mg FHND1002 in people with Amyotrophic Lateral Sclerosis (ALS), run by Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak Plasma Concentration (Cmax) (time frame: 4 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06782958, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.

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