ACTRN12624000238572尚未招募1 期
A Phase 1, Randomized, Blinded, Placebo-controlled, Single Ascending Dose, First-in-human, Study of the Safety, Tolerability, and Pharmacokinetics of APG808 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •1. Healthy men and women, in the opinion of the Investigator and as determined by physical examination, laboratory screening tests, and medical history
- •2. 18 to 65 years of age (inclusive) with a body mass index of 18 to 35 kg/m^2 (kilogram per square meter) (inclusive), weight <120 kg
- •3. Willing and able to speak, read, and understand English, and provide written informed consent after the nature of the study has been explained and prior to the start of any study procedures
- •4. Willing and able to attend the necessary visits to the CRU, and comply with all testing and requirements defined in the protocol
- •5. Willing and able to remain at the study site unit for the duration of the confinement period and return for the outpatient visit(s) defined in the protocol
- •6. Willing to use a highly effective method of contraception from admission through 30 days after EOS (end of the study) or 5 half-lives after the last administration of study drug, whichever is longer
- •7. Willing to abstain from regular, continuous alcohol use (defined as an average of >10 standard drinks per week or at the Investigator's discretion) or tobacco use (defined as >=5 cigarettes per day or equivalent) for 48 hours prior to admission to the CRU (Day -1) and any illicit drug abuse for >=48 hours prior to admission to the CRU (Day -1)
- •8. Non-tattooed, clear injection site (i.e., absence of dermatologic conditions, such as scarring or rash, that may impact the ability to assess injection site reactions) suitable for SC injection and monitoring in the opinion of the Investigator
- •9. Agrees to comply with the drawing of blood samples for the PK and PD assessments
排除标准
- •1. Evidence of clinically significant abnormalities or disease
- •a. Diagnosis of diabetes mellitus
- •b. Positive test for human immunodeficiency virus antibody
- •c. Acute or chronic hepatitis B or C as evidenced by hepatitis B surface antigen and/or hepatitis C antibody; evidence of resolved infection or status post-vaccination with the presence of antibodies or documented absence of viral deoxyribonucleic acid on polymerase chain reaction is allowed
- •d. Diagnosis or suspected diagnosis of immunodeficiency or autoimmune diseases, or undergoing immunosuppressive therapy such as anticancer chemotherapy or radiotherapy before the trial, or has received systemic corticosteroid treatment (topical corticosteroids are acceptable) within the past 120 days before dosing
- •e. Significant history or clinical manifestation of any metabolic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory,
- •endocrine, or psychiatric disorder, acute or chronic infectious diseases and malignancies, as determined by the Investigator
- •f. History or presence of conditions which, in the judgment of the Investigator, are known to
- •interfere with the absorption, distribution, metabolism, or excretion of drugs
- •g. Liver function tests (i.e., alanine aminotransferase, aspartate aminotransferase) >1.5 times the upper limit of normal; elevated bilirubin is not allowed unless due to Gilbert's syndrome
- •h. Neutrophils >1.5 times the upper limit of normal
- •i. Impaired renal function defined as an estimated glomerular filtration rate <60 mL/min/1.73 m^2 (milliliter per minute per square meter) at Screening
- •j. Any other laboratory, vital sign (e.g., hypertension that could be unsafe for study drug administration per Investigator assessment), ECG abnormality (e.g., QTcF prolongation), clinically significant medical condition (e.g., cardiac failure), or finding that, in the Investigator's opinion, is likely to unfavorably alter the risk of study participation, confound study results, or interfere with the study conduct or compliance; participants may be rescreened and tests may be repeated at the Investigator's discretion. Note: participants with history of non-clinically significant disease (e.g., childhood asthma, migraines, non-hospitalized depression, Gilbert syndrome, cholecystectomy) that, in the Investigator's opinion, is not likely to unfavorably alter the risk of study participation, confound study results, or interfere with the study conduct or compliance may be eligible for the study
- •2. Poor peripheral venous access
- •3. Fever (>=38.0°C) within 7 days before study drug administration
- •4. Positive COVID-19 Rapid Antigen Test at admission to the CRU
- •5. Known history of illicit drug abuse, harmful alcohol use (defined as an average of > 10 standard drinks per week or at the Investigator’s discretion) or alcoholism, and/or heavy tobacco use (defined as >=5 cigarettes per day or equivalent) within 2 years prior to Screening (or at the Investigator’s discretion); positive screen for drugs of abuse (except tetrahydrocannabinol), or positive cotinine or alcohol breath test at Screening or admission to the CRU (or at the Investigator’s discretion), and participants must abstain from cigarette smoking for the duration of their stay in the CRU. Participants may be rescreened for drugs of abuse or alcohol breath test at the Investigator’s discretion
- •6. History of severe allergic reactions or hypersensitivity (i.e., a
研究者
相似试验
尚未招募
1 期
A First-in-human Study of APG990 in Healthy ParticipantsAtopic DermatitisACTRN12624000775516Apogee Therapeutics, Inc.40
招募中
1 期
To Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MYK-224 in Healthy VolunteersHypertrophic CardiomyopathyCardiovascular - Other cardiovascular diseasesACTRN12621000423819MyoKardia, Inc.112
撤回
不适用
A Phase 1, Blinded, Randomized, Placebo-controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of BIIB132 Administered Intrathecally to Adults With Spinocerebellar Ataxia 3SCA3NL-OMON51564Biogen6
已完成
不适用
A Phase 1, Randomized, Blinded, Placebo-Controlled, Dose-Ranging Study of MVT-602 in Healthy Premenopausal Womefemale infertilityinduction of ovulation10013356NL-OMON44304Myovant Sciences GmbH40
进行中（未招募）
1 期
A First-in-human Study of APG777 in Healthy ParticipantsSkin - Dermatological conditionsAtopic DermatitisACTRN12623000786695Apogee Therapeutics, Inc40