NL-OMON56273招募中不适用
A Two-Part, Adaptive, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose (SAD) Study to Evaluate Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Intravenous and Intramuscular GM-2505 in Healthy Volunteers - SAD, safety, PK, PD of GM2505 in healthy volunteers
Gilgamesh Pharmaceuticals0 个研究点目标入组 84 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
- 招募中
- 发起方
- 入组人数
- 84
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. Self-report of at least one prior hallucinogen drug experience that included
- •a meaningful altered state of consciousness (a state in which the subject
- •experienced phenomena that altered his psychological functioning, such as loss
- •of ego boundaries, impaired control of actions and cognition, disembodiment,
- •changed meaning of perception, visual alterations, and audio-visual
- •synesthesia) in the past 5 years. Hallucinogenic substances can include
- •psilocybin, LSD, DMT, ayahuasca, mescaline, ibogaine, 2C-drugs (such as 2CB,
- •2CI and 2CE) and/or ketamine.
- •4. Subjects must be willing to adhere to the prohibitions and restrictions
- •specified in the protocol, including attending all study visits, preparatory
- •and follow-up sessions, and completing all study evaluations.
- •5. 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 personal or familial history of epilepsy, seizures,
- •convulsions, or other seizure disorder (excluding febrile seizures as a child),
- •previous head trauma or other risk factor for seizure.
- •8. Clinically significant current or previous psychiatric disorder according to
- •DSM 5. Specifically, current or previous psychotic disorders and bipolar
- •disorder will be excluded.
- •9. Family history of a psychotic disorder (whether in the context of bipolar
- •disorder, schizophrenia or schizoaffective disorder) in first-degree and
- •second-degree relatives.
- •10. 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
- •11. Subject has a current or history of drug or alcohol use disorder according
- •to the to DSM-IV and/or DSM 5 within the past 12 months.
- •12. Use of psychoactive substances (including ketamine, esketamine, MDMA,
- •cannabinoids, and nitrous oxide), during the 6 weeks prior to screening.
- •Single/occasional use may be allowed at the discretion of investigator.
- •13. Ingestion of psychedelics (including psilocybin, DMT/ayahuasca, LSD,
- •another serotonergic psychedelic) during 4 weeks prior to screening.
- •14. 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.
- •15. Subject has a positive test result(s) for alcohol and/or drugs of abuse
- •(including opiates (including methadone), cocaine, amphetamines,
- •methamphetamines, cannabinoids, barbiturates, and benzodiazepines) at screening
- •or admission to the clinical unit.
- •16. Female subjects with a positive urine pregnancy test or who are lactating
- •at screening or admission to the clinical unit, or women of childbearing
- •potential (WOCBP) who are unwilling to use an effective form of contraception
- •(as defined under lifestyle regulations) for the duration of the study and for
- •180 days after the last dose.
- •17. Sexually active male subjects who are unwilling to use an effective form of
- •contraception (as defined under lifestyle regulations) for the duration of the
- •study and for 90 days after the last dose.
- •18. Use of more than 5 cigarettes (or other tobacco or nicotine products with
- •equivalent nicotine dose) daily within the previous month before the first dose
- •administration, and/or unable or unwilling to not smoke durin
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