Testing IAMA-6 oral doses in healthy adults

A Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of IAMA-6 Administered Orally to Healthy Adults

This study is testing different doses of a new oral medication called IAMA-6 in healthy adults to see how safe it is and how it works in the body.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Iama Therapeutics S.r.l. (Industry-sponsored)
• Locations: 1 site (Verona)
• Trial ID: NCT06300398 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of IAMA-6 administered orally to healthy adults. It is a randomized, double-blind, placebo-controlled study that includes both single ascending dose (SAD) and multiple ascending dose (MAD) components. Participants will receive varying doses of IAMA-6 or a placebo, with careful monitoring for any adverse reactions. The study aims to determine the effects of food on the drug's pharmacokinetics as well.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 to 55 with a body mass index between 18.0 and 30.0 kg/m2.

Not a fit: Patients with a history of significant medical conditions or central nervous system problems may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the safety and efficacy of IAMA-6, potentially leading to new treatments for neurodevelopmental disorders.

How similar studies have performed: While this approach is common in early-phase trials, the specific drug IAMA-6 has not been tested in humans before, making this a novel investigation.

Eligibility criteria

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 and males 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 to a maximum of 110 kg.
* The subject must be willing to return to the study centre for study treatment and study-related follow-up procedures as required by the protocol.

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, or other major disease/condition, as determined by the Principal Investigator or Designee.
* Any history of central nervous system problems (e.g. epilepsy, head injury, loss of consciousness).
* Any history of malignancy in the previous 5 years involving any organ system (other than 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 oxygen saturation \<95% by pulse oximetry.
* ECG at screening or on Day -1 showing QTcF interval \>450 msec in males or \>470 msec in females, or presence of any clinically significant dysrhythmia.
* History of hypersensitivity to any medicinal product(s) or severe hypersensitivity/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 for highly 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 to dosing.
* 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.

Where this trial is running

Verona

• Centro Ricerche Cliniche Di Verona S.r.l. — Verona, Italy (Recruiting)

Study contacts

• Principal investigator: Stefano Milleri, MD — Centro Ricerche Cliniche di Verona srl
• Study coordinator: Ciro Spedaliere

Conditions Neurodevelopmental Disorders