Healthy volunteers Other
Conditions
Interventions
Part A (single ascending dose [SAD]):
Part A will test single oral doses of GM-5022 in healthy volunteers (HV) in a placebo-?controlled, double-blind design. Participants will be randomized to receive
only the pharmacy staff involved in handling the trial drug will be unblinded during the trial and will have access to the randomization list).
The starting dose of GM-5022 will be 5 mg and subsequen
the order will be randomized 1:1. The dosing sessions will be separated by a 1-week washout period.
Part C (multiple ascending dose [MAD]):
Part C will test multiple ascending oral doses of GM-5022
only the pharmacy staff involved in handling the trial drug will be unblinded during the trial and will have access to the randomization list. Participants will receive daily oral doses of GM-5022 (or
Sponsors
Gilgamesh Pharma Inc.
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Healthy adult males and females aged 18-55 years, inclusive 2. Body mass index (BMI) of 18.0–30.9 kg/m² (inclusive) at screening 3. Meets the following criteria for psychedelic experience 4. Willing and able to provide informed consent and comply with all trial requirements and study procedures after having discussed the trial with the investigator or their designee 5. Agrees to follow the contraception requirements of the trial (reliable method of contraception for male and female participants) 6. Agrees not to donate blood or blood products during the trial and for up to 3 months after the administration of the trial intervention
Exclusion criteria
Exclusion criteria: Medical history: 1. Female who is pregnant or lactating, or premenopausal who is sexually active and not using a reliable method of contraception 2. Clinically relevant abnormal history, physical findings, ECG, or laboratory values at screening that could interfere with the objectives of the trial or the safety of the participant 3. Presence of acute or chronic illness or history of chronic illness sufficient to invalidate the participant’s participation in the trial or make it unnecessarily hazardous, including impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, or coronary heart disease, hepatitis B or C, or HIV 4. Presence or history of any relevant and/or significant psychiatric history, including personal or family history of psychotic mental illness or mania 5. Surgery (e.g., stomach bypass) or medical condition that might affect absorption of medicines 6. Presence or history of severe adverse reaction to any drug or the excipients present in the capsules 7. Significant risk of suicide, based on a history of suicidal ideation or behavior as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) 8. Any personal or familial history of epilepsy or other convulsive condition (except history of 1–2 febrile seizures occurring younger than age 5), previous significant head trauma or other factor predisposing to seizures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability measured using adverse events (AEs), laboratory assessments (hematology, serum chemistry, urinalysis), vital signs, 12-lead electrocardiogram (ECG), and emergence of suicidal thoughts and ideations (C-?SSRS) at 0-24 h after dosing;Pharmacokinetics measured using plasma concentrations of GM-5022 to determine AUC, Cmax, t1/2, Tmax at 0-24 h after dosing | — |
Countries
United States of America
Contacts
Public ContactGerard Marek
Outcome results
None listed