A three-part study of GM 5022 in healthy adults, looking at safety, side effects, how the body processes the medicine, how the medicine works, and the effects of different doses and food

ISRCTN	ISRCTN10927115
DOI	https://doi.org/10.1186/ISRCTN10927115
Sponsor	Gilgamesh Pharma Inc.
Funder	Gilgamesh Pharma Inc.

Submission date: 27/04/2026
Registration date: 28/04/2026
Last edited: 28/04/2026

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Trisha Shamps
Principal investigator

1000 Westgate Drive, Suite 149
Saint Paul
55114
United States of America

Phone	+1 (0)651 641 2900
Email	t.shamp@nucleusnetwork.com

Dr Gerard Marek
Scientific, Public

Gilgamesh Pharma Inc., 113 University Place, Suite 1019
New York
10003
United States of America

Phone	+1 (0)929 723 4861
Email	info@gilgameshpharmaceutical.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Placebo
Assignment	Single ascending dose; cross-over food effect; and multiple ascending dose
Purpose	Safety, tolerability, pharmacokinetics, pharmacodynamics and food effect
Scientific title	A Phase I three-part study of GM-5022 in healthy volunteers: single ascending dose (randomized placebo controlled); cross-over food effect; and multiple ascending dose (randomized placebo controlled) to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect
Study objectives	To investigate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of GM-5022.
Ethics approval(s)	Approved 07/04/2026, Advarra Institutional Review Board (IRB) (6100 Merriweather Drive, Columbia, MD 21044, United States of America; +1 (0)410 884 2900; cirbi@advarra.com), ref: Pro00094126
Health condition(s) or problem(s) studied	Healthy volunteers
Intervention	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 a single dose of GM-5022 or placebo (in a 3:1 ratio, the randomisation list will be kept in a secure location until the end of the trial; 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 subsequent doses will be calculated based on initial data from the first cohort. Part B (food effect): Part B will assess the effect of food on the PK of orally administered GM-5022 in HVs. Each participant will have two trial sessions in which they will receive GM-5022. Each participant will receive an oral dose of GM-5022 in the fasted state in one session and in the fed state in the other session; 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 or placebo in HVs in a placebo-‍controlled, double-blind design. The randomisation list will be kept in a secure location until the end of the trial; 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 placebo) for 7 days.
Intervention type	Drug
Phase	Phase I
Drug / device / biological / vaccine name(s)	GM-5022
Primary outcome measure(s)	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
Key secondary outcome measure(s)
Completion date	31/05/2027

Eligibility

Participant type(s)
Age group	Adult
Lower age limit	18 Years
Upper age limit	55 Years
Sex	All
Target sample size at registration	112
Key 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
Key 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
Date of first enrolment	29/04/2026
Date of final enrolment	29/04/2027

Locations

Countries of recruitment

United States of America

Study participating centre

Prism Research LLC dba Nucleus Network

1000 Westgate Drive, Suite 149
Saint Paul, MN
55114
United States of America

Results and Publications

Individual participant data (IPD) Intention to share	No

Editorial Notes

28/04/2026: Study's existence confirmed by Advarra Institutional Review Board (IRB).