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क्लिनिकल ट्रायल NCT07489599 के लिए Alzheimer's Disease(AD), हल्का संज्ञानात्मक हानि (MCI) वर्तमान में अभी भर्ती शुरू नहीं है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें।
एक परीक्षण फ़िल्टर मानदंडों से मेल खाता है
कार्ड दृश्य

A Study of QLH2405 in Healthy Participants and Participants With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease चरण I 68

अभी भर्ती शुरू नहीं
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'अध्ययन समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल ट्रायल NCT07489599 का मुख्य उद्देश्य उपचार का अध्ययन करना है। यह चिकित्सकीय अध्ययन Alzheimer's Disease(AD), हल्का संज्ञानात्मक हानि (MCI) से जुड़ा हुआ है और यह एक चरण I हस्तक्रियात्मक परीक्षण है। परीक्षण वर्तमान में अभी भर्ती शुरू नहीं चल रहा है। इसमें 68 प्रतिभागियों को शामिल करने की योजना है और प्रतिभागियों का नामांकन 1 मार्च 2026 से शुरू होगा। Qilu Pharmaceutical Co., Ltd. इस परीक्षण का नेतृत्व कर रहे हैं और इसके 1 मार्च 2027 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 24 मार्च 2026 को अंतिम बार अपडेट की गई थी
संक्षिप्त सारांश
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of QLH2405 injection in healthy participants and participants with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild Alzheimer's disease.
आधिकारिक शीर्षक

A Randomized, Double-Blind, Placebo-Controlled, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single, Subcutaneous, Ascending Doses of QLH2405 Injection in Healthy Participants and Participants With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease

स्वास्थ्य स्थितियां
Alzheimer's Disease(AD)हल्का संज्ञानात्मक हानि (MCI)
अन्य अध्ययन आईडी
  • QLH2405-101
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2026-03
अंतिम अद्यतन प्रकाशित
2026-03-24
अध्ययन की समाप्ति तिथि (अनुमानित)
2027-03
नामांकन (अनुमानित)
68
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
चरण I
स्थिति
अभी भर्ती शुरू नहीं
प्राथमिक उद्देश्य
उपचार
डिज़ाइन आवंटन
यादृच्छिक
हस्तक्षेप मॉडल
समानांतर
अंधकरण
चौहरा अंध
समूह/हस्तक्षेप
प्रतिभागी समूह/शाखाहस्तक्षेप/उपचार
प्रयोगात्मकPart A Cohort 1: Dose level 1 of QLH2405
Participants will receive a single dose of QLH2405 at dose level 1.
QLH2405
QLH2405 will be administered as specified in each treatment arm.
प्रयोगात्मकPart A Cohort 2: Dose level 2 of QLH2405
Participants will receive a single dose of QLH2405 at dose level 2.
QLH2405
QLH2405 will be administered as specified in each treatment arm.
प्लेसबो तुलना समूहPart A Cohort 2: Placebo
Participants will receive a single dose of matching placebo to level 2.
प्लेसबो
QLH2405-matching placebo will be administered as specified in each treatment arm.
प्रयोगात्मकPart A Cohort 3: Dose level 3 of QLH2405
Participants will receive a single dose of QLH2405 at dose level 3.
QLH2405
QLH2405 will be administered as specified in each treatment arm.
प्लेसबो तुलना समूहPart A Cohort 3: Placebo
Participants will receive a single dose of matching placebo to level 3.
प्लेसबो
QLH2405-matching placebo will be administered as specified in each treatment arm.
प्रयोगात्मकPart A Cohort 4: Dose level 4 of QLH2405
Participants will receive a single dose of QLH2405 at dose level 4.
QLH2405
QLH2405 will be administered as specified in each treatment arm.
प्लेसबो तुलना समूहPart A Cohort 4: Placebo
Participants will receive a single dose of matching placebo to level 4.
प्लेसबो
QLH2405-matching placebo will be administered as specified in each treatment arm.
प्रयोगात्मकPart A Cohort 5: Dose level 5 of QLH2405
Participants will receive a single dose of QLH2405 at dose level 5.
QLH2405
QLH2405 will be administered as specified in each treatment arm.
प्लेसबो तुलना समूहPart A Cohort 5: Placebo
Participants will receive a single dose of matching placebo to level 5.
प्लेसबो
QLH2405-matching placebo will be administered as specified in each treatment arm.
प्रयोगात्मकPart A Cohort 6: Dose level 6 of QLH2405
Participants will receive a single dose of QLH2405 at dose level 6.
QLH2405
QLH2405 will be administered as specified in each treatment arm.
प्लेसबो तुलना समूहPart A Cohort 6: Placebo
Participants will receive a single dose of matching placebo to level 6.
प्लेसबो
QLH2405-matching placebo will be administered as specified in each treatment arm.
प्रयोगात्मकPart B Cohort 1: Dose level 3 of QLH2405
Participants will receive a single dose of QLH2405 at dose level 3.
QLH2405
QLH2405 will be administered as specified in each treatment arm.
प्लेसबो तुलना समूहPart B Cohort 1: Placebo
Participants will receive a single dose of matching placebo to level 3.
प्लेसबो
QLH2405-matching placebo will be administered as specified in each treatment arm.
प्रयोगात्मकPart B Cohort 2: Dose level 4 of QLH2405
Participants will receive a single dose of QLH2405 at dose level 4.
QLH2405
QLH2405 will be administered as specified in each treatment arm.
प्लेसबो तुलना समूहPart B Cohort 2: Placebo
Participants will receive a single dose of matching placebo to level 4.
प्लेसबो
QLH2405-matching placebo will be administered as specified in each treatment arm.
प्रयोगात्मकPart B Cohort 3: Dose level 5 of QLH2405
Participants will receive a single dose of QLH2405 at dose level 5.
QLH2405
QLH2405 will be administered as specified in each treatment arm.
प्लेसबो तुलना समूहPart B Cohort 3: Placebo
Participants will receive a single dose of matching placebo to level 5.
प्लेसबो
QLH2405-matching placebo will be administered as specified in each treatment arm.
प्राथमिक परिणाम माप
परिणाम मापमाप विवरणसमय सीमा
Adverse Events (AEs)
Percentage of Participants with AEs
Up to approximately 28 weeks
भागीदारी सहायक
पात्रता मानदंड

अध्ययन के लिए पात्र आयु
वयस्क, वृद्ध वयस्क
अध्ययन के लिए न्यूनतम आयु
18 Years
अध्ययन के लिए पात्र लिंग
सभी
स्वस्थ स्वयंसेवकों को स्वीकार करता है
हाँ
  1. Voluntarily participate and sign the informed consent.
  2. Male or female, aged 18 to 65 years (inclusive).
  3. Healthy status as confirmed by medical evaluation.
  4. Body mass index (BMI) of 19-28 kg/m² (inclusive).
  5. Agree to use effective contraception and have no plans for sperm/egg donation or pregnancy from ICF signing until 9 months post-dose.

Inclusion Criteria for Part B:

  1. Voluntarily participate and sign the informed consent, able to communicate well with the investigator and complete the trial per protocol.
  2. Male or female, aged 50 to 85 years (inclusive).
  3. A diagnosis of mild MCI due to AD or mild AD according to the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria.
  4. Has subjective cognitive and memory decline for ≥6 months.
  5. Confirmation of Alzheimer's disease pathological changes by amyloid PET (Aβ-PET) scan.
  6. Has one (or more) reliable study partner (s)/adult caregiver(s) can accompany the participant to all visits.
  7. Agree to use effective contraception and have no plans for sperm/egg donation or pregnancy from ICF signing until 9 months post-dose.

  1. History of significant diseases, or any existing disease may affect the study or pose an unacceptable risk to the participant.
  2. Positive for HBsAg, HIV-Ab, Treponema pallidum antibody, or HCV-Ab.
  3. History of blood donation, significant blood loss (total volume ≥400 mL), or blood transfusion within 3 months prior to screening.
  4. History of alcohol abuse within 1 year prior to screening; or positive alcohol breath test.
  5. History of drug abuse and/or substance abuse; or positive drug screening.
  6. Participation in any drug or medical device clinical trial within 3 months prior to screening.
  7. Pregnant or lactating women, or women of childbearing potential with a positiveβ-hCG test.
  8. Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in this study.

Exclusion Criteria for Part B:

  1. Cognitive impairment or dementia caused by any disease other than AD.
  2. History of stroke within 6 months prior to screening, or imaging evidence of clinically significant central nervous system diseases.
  3. History of epileptic seizures or epileptiform abnormalities on EEG within 6 months prior to screening.
  4. Unstable or severe diseases within 6 months prior to screening that, in the investigator's judgment, make the participant unsuitable for study participation.
  5. eGFR <60 mL/min/1.73 m².
  6. AST or ALT >3 × upper limit of normal (ULN), or total bilirubin >2 × ULN.
  7. Current use or anticipated need during the study period for any medication prohibited by the study protocol.
  8. Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in this study.
Qilu Pharmaceutical Co., Ltd. logoQilu Pharmaceutical Co., Ltd.
अध्ययन केंद्रीय संपर्क
संपर्क: Fangyi Wang, Bachelor, +86-18266419923, [email protected]
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