NL-OMON56273
Recruiting
Not Applicable
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 sites84 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- depression
- Sponsor
- Gilgamesh Pharmaceuticals
- Enrollment
- 84
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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