NCT06782958 (FHND1002-Ⅰ) is a Phase 1 clinical trial of 50mg FHND1002 in Amyotrophic Lateral Sclerosis (ALS), sponsored by Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd..

Who is sponsoring NCT06782958?

NCT06782958 is sponsored by Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd..

What drugs are being tested in NCT06782958?

Interventions in NCT06782958: 50mg FHND1002, 100mg FHND1002, 150 mg FHND1002, 200 mg FHND1002（fasting）, 250mg FHND1002, 200mg FHND1002(postprandial).

What condition does NCT06782958 study?

NCT06782958 studies Amyotrophic Lateral Sclerosis (ALS).

Is NCT06782958 still recruiting?

NCT06782958 is currently enrolling by invitation. Last updated 20 January 2025.

Last reviewed 2025-01-20 · How we verify

NCT06782958: FHND1002-Ⅰ

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

ENROLLING BY INVITATION Phase 1 Last updated 20 January 2025

What this trial tests

Phase 1 trial testing 50mg FHND1002 in Amyotrophic Lateral Sclerosis (ALS) in 72 participants. Enrolling by invitation.

Timeline

5 July 2024

Primary endpoint
3 March 2025

5 June 2025

Quick facts

Lead sponsor	Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.
Phase	Phase 1
Status	ENROLLING BY INVITATION
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	72
Start date	5 July 2024
Primary completion	3 March 2025
Estimated completion	5 June 2025
Sites	1 location across China

Drugs / interventions tested

50mg FHND1002 — full drug profile →
100mg FHND1002
150 mg FHND1002 — full drug profile →
200 mg FHND1002（fasting） — full drug profile →
250mg FHND1002 — full drug profile →
200mg FHND1002(postprandial) — full drug profile →

Conditions studied

Amyotrophic Lateral Sclerosis (ALS) — all drugs for Amyotrophic Lateral Sclerosis (ALS) →

Sponsor

Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd. — full company profile →

Who can join

Adults 18 to 45, any sex, with Amyotrophic Lateral Sclerosis (ALS). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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: 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Amyotrophic lateral sclerosis in Mainland China: clinical translational challenges and opportunities.
He J, Fan D. · · 2025 · cited 1× · PMID 40772655 · DOI 10.1097/wco.0000000000001421

Verify or expand the search:

Other recruiting trials for Amyotrophic Lateral Sclerosis (ALS)

Currently open trials in the same condition.

NCT06608004 — Influence of Olfacto-gustatory Sensoriality on the Nutritional Status of Patients With Amyotrophic Lateral Sclerosis · recruiting
NCT07187388 — Investigating the Impact of Electrical Stimulation on Facial Pain, Jaw Movement and Oral Health in People With Motor Neu · NA · recruiting
NCT07233148 — Healing ALS Registry Observational Study (HAROS) · recruiting
NCT07257302 — Lung Insufflation Capacity Training and Respiratory Function in Amyotrophic Lateral Sclerosis · NA · recruiting
NCT07118319 — The Safety, Tolerability and Preliminary Efficacy of Derived Motor Neuron Progenitor Cells (XS228CN) in Subjects With Am · Phase 1 · recruiting

Other Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd. trials

Trials by the same sponsor.

NCT07138014 — FHND1002 for ALS Treatment: Phase 2 · Phase 2 · not yet recruiting
NCT06762743 — Bioequivalence Study of Two Brivaracetam Oral Solutions in Healthy Adults Under Fasting and High-Fat Meal Conditions · Phase 1 · enrolling by invitation
NCT05818917 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Evidence of Antitumor Activity of FHND507 · Phase 1 · unknown
NCT05271682 — A Study Evaluating Safety, Tolerability and Clinical Activity of FHND6091 in Patients With Multiple Myeloma · Phase 1 · unknown
NCT06759857 — FHND9041 Versus Afatinib for Non-small Cell Lung Cancer · Phase 3 · enrolling by invitation

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06782958 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.
Last refreshed: 20 January 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06782958.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing