CTRI/2024/01/061919尚未招募Unknown
A Randomized, Double-Blinded, Placebo-Controlled, Parallel Study To AssessThe Efficacy And Safety Of CG-A1 Peptide In Patients With Muscle Atrophy. - NI
Caregen.Co., Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Male and female subjects who are 18 years of age and older of any ethnicity
- •2.Subjects with pathologic or physiologic muscle atrophy
- •3.Subjects with low muscle strength defined as less than 28 kg for men and less than18 kg for women assessed by hand dynamometer or low physical performance assessed by 6-meter walk test 6-meter walk less than 1m s
- •4.Non-smoker
- •5.Subjects who are accustomed to normal levels of physical activity except for bed ridden patients
- •6.Body mass index less than 25 kg m2
- •7.Vital signs are normal, or deemed abnormal but clinically insignificant by the Investigator
- •8.Clinical laboratory evaluations are normal or deemed clinically insignificant by the Investigator
- •9.Males who are sterile or agree to use an approved method of contraception, with an approved method of contraception considered a barrier method plus a contraceptive jelly. If the female sexual partner of the male is using an approved form of contraception or is not of child-bearing potential, the male is not required to be sterile or, if not sterile, to use an approved form of contraception
- •10.Female subjects who are-Postmenopausal, Surgically sterilized ,WOCBP who are non-lactating and have been using an effective form of birth control for a minimum of 6 months prior to screening and agree to continue using the effective form of birth control during the study and for 30 days after the treatment period effective forms of birth control include oral pills with a concentration of at least 50 µg of the estrogenic component of a biphasic or triphasic pill, transdermal, injectable, or implantable contraceptive, intrauterine device and intrauterine system or double-barrier method
- •WOCBP who are using low dose oral birth control must also use a barrier method of contraception for the duration of the study
- •11.Subjects who are capable of providing informed consent and complying with all study
- •Procedures and requirements
排除标准
- •1. Presence of any uncontrolled systemic disease (e.g. cardiovascular disease, hypertension, diabetes
- •mellitus etc.)
- •2. Presence of musculoskeletal or neurological disorders
- •3. Regular consumption of any analgesic or anti-inflammatory drug(s), either prescription or non-prescription
- •4. Taking any medications known to affect protein metabolism (e.g. b-blockers, corticosteroids, non-steroidal anti- inflammatory, or prescription strength acne medications). Additional medications and or supplementation aids (e.g. whey protein) will be deemed inappropriate based on the investigator’s
- •discretion.
- •5. Recent (within 6 months) treatment with anabolic steroids.
- •6. Dietary conditions
- •a. Diet restrictions including vegetarianism, veganism, soy-free diet,
- •b. Fish and or fish oil allergy or intolerance
- •c. Milk allergy excluding lactose intolerance.
- •d. Follows a kosher diet.
- •7. Medications
- •a. Use of appetite stimulants (including megestrol, dronabinol and cyproheptadine).
- •b. If participant is already taking a fish oil supplement, he or she must be willing to either stop the supplement.
- •8. Additional
- •a. Patient has implantable device such as a pacemaker or ICD
- •b. Hospitalization within the last 30 days
- •c. Living in a skilled nursing facility or long-term care facility
- •9. Participation in clinical trials human studies within 1 month of the start of this study and received other medicines or has applied other medical devices.
- •10. Person who is expected to receive other medicines or applied medical devices by participating in other clinical trials human studies during the participation period in this study.
- •11. Women who plan to become pregnant during the study, are pregnant or lactating, or were pregnant or nursing within the past year.
- •12. Subjects who have any condition or showing symptoms of a condition that would make them, in the opinion of the Investigator, unsuitable for the study.
研究者
相似试验
进行中（未招募）
1 期
The metastatic castration-resistant prostate cancer (mCRPC) patients with homologous recombination repair (HRR) gene alterations who have notprogressed after docetaxel therapymetastatic castration-resistant prostate cancer (mCRPC)MedDRA version: 21.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10076506Term: Castration-resistant prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2021-001205-73-ITIMPACT Therapeutics Inc.165
进行中（未招募）
3 期
Study to Assess the Effects of Deglusterol on Fasting Glucose and Other Cardiometabolic Risk Factors.CTRI/2023/01/048723Caregen Co., Ltd.
进行中（未招募）
3 期
Study to Assess the Effects of Deglusterol on Fasting Glucose and Other Cardiometabolic Risk Factors in type 2 diabetes mellitus patients who are on Metformin + gliptin combination therapy.CTRI/2024/01/062047Caregen Co., Ltd.
进行中（未招募）
3 期
Study to Assess the Effects of Deglusterol on Type 2 Diabetes Mellitus.CTRI/2023/07/054724Caregen Co., Ltd.
进行中（未招募）
1 期
The metastatic castration-resistant prostate cancer (mCRPC) patients with homologous recombination repair (HRR) gene alterations who have not progressed after docetaxel therapymetastatic castration-resistant prostate cancer (mCRPC)MedDRA version: 21.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10076506Term: Castration-resistant prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2021-001205-73-BEIMPACT Therapeutics, Inc.660