Safety, Tolerability, and Pharmacokinetics of FHND1002 Granules in Healthy Adults
NCT ID: NCT06782958
Last Updated: 2025-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
PHASE1
72 participants
INTERVENTIONAL
2024-07-05
2025-06-05
Brief Summary
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The main questions this study aims to answer are:
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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Single dose
Participants 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).
50mg FHND1002
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 FHND1002
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 FHND1002
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）
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 FHND1002
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)
Participants will receive a one-time dose (200 mg) under postprandial conditions
Multiple dose
Participants will receive daily doses (100 mg, 150 mg, or 200 mg) for 7 consecutive days under fasting conditions.
100mg FHND1002
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 FHND1002
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）
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.
Placebo
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.
50mg FHND1002
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 FHND1002
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 FHND1002
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）
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 FHND1002
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)
Participants will receive a one-time dose (200 mg) under postprandial conditions
Interventions
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50mg FHND1002
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 FHND1002
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 FHND1002
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）
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 FHND1002
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)
Participants will receive a one-time dose (200 mg) under postprandial conditions
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* 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.
18 Years
45 Years
ALL
Yes
Sponsors
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Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Ting Wang
Role: PRINCIPAL_INVESTIGATOR
LanZhou University
Locations
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The first hospital of Lanzhou University
Lanzhou, Gansu, China
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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FHND1002-I-01
Identifier Type: -
Identifier Source: org_study_id
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