Last updated: March 8, 2024
Sponsor: Iama Therapeutics S.r.l.
Overall Status: Active - Recruiting
Phase
1
Condition
Neurologic Disorders
Autism
Holoprosencephaly
Treatment
Placebo
IAMA-6
Clinical Study ID
NCT06300398
ECS_IAMA23_0101
Ages 18-55 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Healthy male and female subjects.
- Aged between 18 and 55 years.
- Written informed consent; willing and able to comply with procedures.
- Females will not be pregnant or lactating, and females of childbearing potential andmales will agree to use contraception.
- Body mass index of 18.0 to 30.0 kg/m2, inclusive; and a total body weight >50 kg up toa maximum of 110 kg.
- The subject must be willing to return to the study centre for study treatment andstudy-related follow-up procedures as required by the protocol.
Exclusion
Exclusion Criteria:
- Current or past history of a clinically significant (as judged by the Investigator)cardiovascular, cerebrovascular, respiratory, gastrointestinal, hematologic, renal,hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, orother major disease/condition, as determined by the Principal Investigator orDesignee.
- Any history of central nervous system problems (e.g. epilepsy, head injury, loss ofconsciousness).
- Any history of malignancy in the previous 5 years involving any organ system (otherthan localised basal cell carcinoma of the skin).
- Body Mass Index: <18 kg/m2 , or >30 kg/m2.
- Abnormal vital signs, including known history of hypertension, resting oxygensaturation <95% by pulse oximetry.
- ECG at screening or on Day -1 showing QTcF interval >450 msec in males or >470 msec infemales, or presence of any clinically significant dysrhythmia.
- History of hypersensitivity to any medicinal product(s) or severehypersensitivity/anaphylaxis with unclear aetiology.
- Any clinically significant abnormal chemistry values.
- Any clinically significant abnormal haematology values.
- Blood donation within the past 3 months.
- Seropositivity for HBsAg, HCV, HIV 1, or HIV 2.
- Has a positive nasopharyngeal test for SARS-CoV-2 within 48h before unit admission.
- If female, has a positive highly sensitive urine pregnancy test at Screening or Day 1.
- If female and of child-bearing potential, and not meeting the approved criteria forhighly effective methods of birth control.
- Receipt of any Investigational Drug within the past 6 months.
- Use of prescription medication within 14 days prior to dosing and antibiotics within 30 days prior to dosing.
- Intake of OTC preparations, vitamins, minerals, herbal remedies within 48h prior todosing.
- Current smokers or history of smoking in previous 6 months.
- Current or history of drug, alcohol, nicotine abuse, or excessive coffee (>5 cups/day)or tea drinking (>5 cups/day).
- Inadequate comprehension of study risks and requirements.
Study Design
Total Participants: 72
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
January 08, 2024
Estimated Completion Date:
September 30, 2024
Study Description
Connect with a study center
Centro Ricerche Cliniche Di Verona S.r.l.
Verona,
ItalyActive - Recruiting
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