NL-OMON53597已完成不适用
A Three-Part, Adaptive, Randomized, Double blind, Placebo Controlled First in Human Study to Evaluate Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Single and Multiple Ascending Oral Doses of GM-1020 and the Effect of Food on Single Dose GM-1020 in Healthy Volunteers. - SAD and MAD safety, PK and PD, PK and Food Effect of GM-1020
Gilgamesh Pharmaceuticals0 个研究点目标入组 116 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 116
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
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Healthy female or male subjects, 18 to 55 years of age, inclusive. Healthy
- •status is defined by absence of evidence of any active or chronic disease
- •following a detailed medical, surgical a complete physical examination
- •including vital signs, 12-lead ECG, hematology, blood chemistry, and
- •urinalysis. If the results of the serum chemistry panel, hematology, or
- •urinalysis are outside the normal reference ranges, the subject may be included
- •only if the investigator judges the abnormalities to be not clinically
- •significant.
- •2. Subject has a body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive
- •(BMI=weight/height2) at screening.
- •3. Subjects must be willing to adhere to the prohibitions and restrictions
- •specified in the protocol, including attending all study visits and completing
- •all study evaluations.
- •4. Each subject must sign an informed consent form (ICF) indicating that he or
- •she understands the purpose and procedures required for the study and are
- •willing to participate in the study. Agree to refrain from using any
- •psychoactive drugs from 30 days before first dosing and until the last follow
- •up visit and to refrain from using alcoholic beverages within 48 hours prior to
- •admission of each treatment period.
排除标准
- •1. Clinically significant current or previous liver or renal insufficiency,
- •cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic,
- •hematologic, rheumatologic, metabolic or inflammatory illness, or any other
- •illness that would compromise the well-being of the subject or the study or
- •prevent the subject from meeting or performing study requirements according to
- •the investigator.
- •3.Subject has a history of or current hypertension (resting systolic blood
- •pressure > 130 mmHg or diastolic blood pressure >90 mmHg) at screening.
- •5. Resting heart rate (HR) greater than 100 or less than 45 beats per minute
- •(bpm) at screening.
- •7. Clinically significant current or previous psychiatric disorder according to
- •8. Family history of a psychotic disorder in first-degree and second-degree
- •9. Clinically significant current or previous suicidality based on the C-SSRS
- •and psychiatric history indicating current suicidal ideation or a history of
- •active suicidal ideation or suicide attempts
- •10. Subject has a current or history of drug or alcohol use disorder according
- •to DSM 5 within the past 12 months.
- •11. Structural use of psychoactive substances (including ketamine, esketamine,
- •MDMA, cannabinoids, or psychedelics) during the 6 weeks prior to screening.
- •Ingestion of psilocybin, DMT, LSD, MDMA, or another serotonergic psychedelic
- •within the last 4 weeks.
- •12. Persistent psychological effects following the previous use of psilocybin,
- •LSD, DMT, ayahuasca, mescaline, ibogaine, 2C-drugs (such as 2CB, 2CI and 2CE)
- •and/or ketamine. Such effects might include but are not limited to anxiety,
- •depressed mood, paranoid ideation and/or hallucinations (including hallucinogen
- •persisting perception disorder - HPPD) or recurrent flashbacks related to use.
- •13. Subject has a positive test result(s) for alcohol and/or drugs of abuse
- •(including opiates, cocaine, amphetamines, methamphetamines, cannabinoids,
- •ketamine and benzodiazepines) at screening or admission to the clinical unit.
研究者
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