Testing IAMA-6 oral doses in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: ciro.spedaliere@iamatherapeutics.com
• Phone: +39 3293532484

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.