Neurodevelopmental DisordersPhase 1NCT06300398
IAMA-6 Oral Dose Study in Healthy Adults
A Phase 1 study testing IAMA-6 in people with Neurodevelopmental Disorders, run by Iama Therapeutics S.r.l. at 1 site in Italy.
Trial summary
The main purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of IAMA-6 administered orally to healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurodevelopmental Disorders
- What is being tested?
- IAMA-6
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteItaly
- Study dates
- 8 Jan 2024to 20 Nov 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
The main purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of IAMA-6 administered orally to healthy adults.
Read the detailed description
The Sponsor's proposed clinical trial is a randomized, double blind, placebo controlled first in human study. This is a single ascending dose (SAD) and multiple ascending dose (MAD) study to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of IAMA-6 administered orally to healthy adults.
The study consists of the following 3 elements:
Part A: Single Ascending Dose
Part A includes up to 6 cohorts of 8 healthy male and female participants, each receiving a single oral dose of IAMA-6 or placebo (6 IAMA-6 and 2 placebo):
- Group A1 (N=8): IAMA-6 Dose 1 (N=6) or Placebo (N=2)
- Group A2 (N=8): IAMA-6 Dose 2 (N=6) or Placebo (N=2)
- Group A3 (N=8): IAMA-6 Dose 3 (N=6) or Placebo (N=2)
- Group A4 (N=8): IAMA-6 Dose 4 (N=6) or Placebo (N=2)
- Group A5 (N=8): IAMA-6 Dose 5 (N=6) or Placebo (N=2)
- Group A6 (N=8): IAMA-6 Dose 6 (N=6) or Placebo (N=2)
In each cohort, treatment will be randomly assigned, such that 2 participants (1 IAMA-6 and 1 placebo) will be dosed first, as sentinel subjects. If safety and tolerability results are acceptable, based on any adverse reactions or events, after at least 24 hours, the remaining 6 participants will be randomly assigned treatment (5 IAMA-6 and 1 placebo) and dosed. All doses will be taken in a fasting state.
Dose escalation will only occur after all safety data from the completed dose group have been reviewed by the sponsor and site investigator, and it has been determined safe to proceed to the next dose cohort.
Part B: Food Effect After completion of the SAD dose escalation (Part A and review of the PK and safety data, one cohort of subjects who received IAMA-6 (n = 6) at the highest safe dose with measurable exposure, will return to the clinic to receive a 2nd dose of IAMA-6 in the fed state to determine the potential effect of food on the bioavailability of IAMA-6 before initiating Part C. The dose of IAMA-6 will be taken after a high fat meal as described in regulatory guidelines (FDA model).
Part C: Multiple Ascending Dose Part C includes up to 3 cohorts of 8 healthy male and female participants, each receiving oral doses of IAMA-6 or placebo (6 IAMA-6 and 2 placebo) for 7 consecutive days, as follows, the doses and the posology being selected according to their acceptable safety, tolerability and pharmacokinetics in Part A. Doses will be taken either with or without food according to the results of Part B of the study.
- Group C1 (N=8): IAMA-6 Dose X (N=6) or Placebo (N=2)
- Group C2 (N=8): IAMA-6 Dose Y (N=6) or Placebo (N=2)
- Group C3 (N=8): IAMA-6 Dose Z (N=6) or Placebo (N=2)
In each cohort, treatment will be randomly assigned, such that 2 participants (1 IAMA-6 and 1 placebo) will be dosed first, as sentinel subjects. If the safety and tolerability results are acceptable, based on any reaction or adverse events, after at least 72 hours, the 6 remaining participants will be randomly assigned treatment (5 IAMA-6 and 1 placebo) and dosed. There will be a 7 day follow up after last dosing for all participants followed by review of clinical and laboratory safety data before starting treatment of the next dose cohort.
- Conditions
- Neurodevelopmental Disorders
- Being tested
- IAMA-6, Placebo
- Medical subject headings
- Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IAMA-6Drug
IAMA-6 liquid suspension
PlaceboDrug
Placebo-to-match IAMA-6 liquid suspension
| Study group | Role | What they receive |
|---|---|---|
| Part A: Single Ascending Dose (SAD) | Experimental | Single oral doses (6 dose cohorts) of IAMA-6 liquid suspension or placebo-to-match IAMA-6 liquid suspension in fasted participants Receives: Drug: IAMA-6; Drug: Placebo |
| Part B: Food Effect (FE) | Experimental | Single oral dose (1 dose cohort) of IAMA-6 liquid suspension in fed participants Receives: Drug: IAMA-6 |
| Part C: Multiple Ascending Dose (MAD) | Experimental | Multiple oral doses (3 dose cohorts) of IAMA-6 liquid suspension or placebo-to-match IAMA-6 liquid suspension for 7 days in fasted or fed participants Receives: Drug: IAMA-6; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs)
All AEs will be coded by Medical Dictionary for Regulatory Activities (MedDRA; Version 26.1 or later) System Organ Class and Preferred Term. The incidence of the following events will be summarized by treatment group and study part (i.e. Part A, Part B and Part C):
- Treatment-emergent AEs (TEAEs).
- TEAEs by severity.
- TEAEs by causality.
- Serious TEAEs.
Measured: From time of the first dose to study completion, an average of 1 year
Number of participants with serious adverse events (SAEs)
All AEs will be coded by Medical Dictionary for Regulatory Activities (MedDRA; Version 26.1 or later) System Organ Class and Preferred Term. The incidence of the following events will be summarized by treatment group and study part (i.e. Part A, Part B and Part C):
- Treatment-emergent AEs (TEAEs).
- TEAEs by severity.
- TEAEs by causality.
- Serious TEAEs.
Measured: From time of the first dose to study completion, an average of 1 year
Number of participants with physical examination abnormalities
Physical examinations and mean changes from baseline (when applicable) will be descriptively summarized by treatment group and study part (i.e. Part A, Part B and Part C).
Measured: Part A: Baseline and Day 8; Part B: Day 8; Part C: Baseline and Day 14
Number of participants with vital sign abnormalities
Vital sign parameters and mean changes from baseline (when applicable) will be descriptively summarized by treatment group and study part (i.e. Part A, Part B and Part C).
Measured: Part A: Baseline and Days 1, 2 and 8; Part B: Days 1, 2 and 8; Part C: Baseline and Days 1-8 and 14
Number of participants with electrocardiogram (ECG) abnormalities
Electrocardiogram measurements and mean changes from baseline will be descriptively summarized by treatment group and study part (i.e. Part A, Part B and Part C).
Measured: Part A: Baseline and Days 1, 2 and 8; Part B: Days 1, 2 and 8; Part C: Baseline and Days 1-8 and 14
Number of participants with clinical laboratory abnormalities
Clinical laboratory test parameters and mean changes from baseline will be descriptively summarized by treatment group and study part (i.e. Part A, Part B and Part C).
Measured: Through study completion, an average of 1 year
Number of participants with hearing abnormalities
The results of the hearing tests (Part C) will be descriptively summarized by timepoint and the change vs baseline (when applicable) will also be analysed.
Hearing tests performed: High Frequency Audiometry (HFA) and Pure Tone Audiometry (PTA).
Measured: Part C: Screening and Day 6
Secondary outcomes (11)
Cmax pharmacokinetic (PK) parameter of IAMA-6 following single and multiple oral doses
Pharmacokinetic concentrations and/or parameters will be summarized using descriptive statistics by treatment arm and study part (i.e. SAD/MAD).
Measured: Parts A and B: Day 1, Day 2 and Day 3; Part C: Day 1 Day 2, Day 7, Day 8 and Day 9
Tmax pharmacokinetic (PK) parameter of IAMA-6 following single and multiple oral doses
Pharmacokinetic concentrations and/or parameters will be summarized using descriptive statistics by treatment arm and study part (i.e. SAD/MAD).
Measured: Parts A and B: Day 1, Day 2 and Day 3; Part C: Day 1 Day 2, Day 7, Day 8 and Day 9
T1/2 pharmacokinetic (PK) parameter of IAMA-6 following single and multiple oral doses
Pharmacokinetic concentrations and/or parameters will be summarized using descriptive statistics by treatment arm and study part (i.e. SAD/MAD).
Measured: Parts A and B: Day 1, Day 2 and Day 3; Part C: Day 1 Day 2, Day 7, Day 8 and Day 9
AUC(0-t) and AUCτ pharmacokinetic (PK) parameters of IAMA-6 following single and multiple oral doses
Pharmacokinetic concentrations and/or parameters will be summarized using descriptive statistics by treatment arm and study part (i.e. SAD/MAD).
Measured: Parts A and B: Day 1, Day 2 and Day 3; Part C: Day 1 Day 2, Day 7, Day 8 and Day 9
Vd pharmacokinetic (PK) parameters of IAMA-6 following single and multiple oral doses
Pharmacokinetic concentrations and/or parameters will be summarized using descriptive statistics by treatment arm and study part (i.e. SAD/MAD).
Measured: Parts A and B: Day 1, Day 2 and Day 3; Part C: Day 1 Day 2, Day 7, Day 8 and Day 9
CL pharmacokinetic (PK) parameters of IAMA-6 following single and multiple oral doses
Pharmacokinetic concentrations and/or parameters will be summarized using descriptive statistics by treatment arm and study part (i.e. SAD/MAD).
Measured: Parts A and B: Day 1, Day 2 and Day 3; Part C: Day 1 Day 2, Day 7, Day 8 and Day 9
λz pharmacokinetic (PK) parameters of IAMA-6 following single and multiple oral doses
Pharmacokinetic concentrations and/or parameters will be summarized using descriptive statistics by treatment arm and study part (i.e. SAD/MAD).
Measured: Parts A and B: Day 1, Day 2 and Day 3; Part C: Day 1 Day 2, Day 7, Day 8 and Day 9
Urine volume
Urine volume will be summarized using descriptive statistics by treatment arm and study part (i.e. SAD/MAD).
Measured: Before treatment (Day -1) and after treatment (Day 1 in Part A and Day 7 in Part C) for a 24-hour period
Na+ excretion
Urinary sodium concentration will be summarized using descriptive statistics by treatment arm and study.
Measured: Before treatment (Day -1) and after treatment (Day 1 in Part A and Day 7 in Part C) for a 24-hour period
K+ excretion
Urinary potassium concentration will be summarized using descriptive statistics by treatment arm and study.
Measured: Before treatment (Day -1) and after treatment (Day 1 in Part A and Day 7 in Part C) for a 24-hour period
Sleep assessment
Sleep assessment using the Leeds Sleep Evaluation Questionnaire (LSEQ). Score between 0 and 100 for each question (total of 10 questions). Higher scores mean a worse outcome.
The results of the questionnaire will be descriptively summarized by timepoint and the change vs baseline (when applicable) will also be analysed.
Measured: Day 2 (Parts A, B, C), Days 8 and 9 (Part C)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start8 Jan 2024
- Primary completion10 Oct 2024
- Study completion20 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodevelopmental DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iama Therapeutics S.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stefano Milleri, MD, Principal investigator, Centro Ricerche Cliniche di Verona srl
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300398
- Sponsor's protocol ID
- ECS_IAMA23_0101
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2024
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06300398
- Acronym / sponsor ID
- ECS_IAMA23_0101
- Conditions
- Neurodevelopmental Disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Iama Therapeutics S.r.l.Industry (pharma, biotech, devices)
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of IAMA-6 administered orally to healthy adults.
Detailed description
The Sponsor's proposed clinical trial is a randomized, double blind, placebo controlled first in human study. This is a single ascending dose (SAD) and multiple ascending dose (MAD) study to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of IAMA-6 administered orally to healthy adults.
The study consists of the following 3 elements:
Part A: Single Ascending Dose
Part A includes up to 6 cohorts of 8 healthy male and female participants, each receiving a single oral dose of IAMA-6 or placebo (6 IAMA-6 and 2 placebo):
- Group A1 (N=8): IAMA-6 Dose 1 (N=6) or Placebo (N=2)
- Group A2 (N=8): IAMA-6 Dose 2 (N=6) or Placebo (N=2)
- Group A3 (N=8): IAMA-6 Dose 3 (N=6) or Placebo (N=2)
- Group A4 (N=8): IAMA-6 Dose 4 (N=6) or Placebo (N=2)
- Group A5 (N=8): IAMA-6 Dose 5 (N=6) or Placebo (N=2)
- Group A6 (N=8): IAMA-6 Dose 6 (N=6) or Placebo (N=2)
In each cohort, treatment will be randomly assigned, such that 2 participants (1 IAMA-6 and 1 placebo) will be dosed first, as sentinel subjects. If safety and tolerability results are acceptable, based on any adverse reactions or events, after at least 24 hours, the remaining 6 participants will be randomly assigned treatment (5 IAMA-6 and 1 placebo) and dosed. All doses will be taken in a fasting state.
Dose escalation will only occur after all safety data from the completed dose group have been reviewed by the sponsor and site investigator, and it has been determined safe to proceed to the next dose cohort.
Part B: Food Effect After completion of the SAD dose escalation (Part A and review of the PK and safety data, one cohort of subjects who received IAMA-6 (n = 6) at the highest safe dose with measurable exposure, will return to the clinic to receive a 2nd dose of IAMA-6 in the fed state to determine the potential effect of food on the bioavailability of IAMA-6 before initiating Part C. The dose of IAMA-6 will be taken after a high fat meal as described in regulatory guidelines (FDA model).
Part C: Multiple Ascending Dose Part C includes up to 3 cohorts of 8 healthy male and female participants, each receiving oral doses of IAMA-6 or placebo (6 IAMA-6 and 2 placebo) for 7 consecutive days, as follows, the doses and the posology being selected according to their acceptable safety, tolerability and pharmacokinetics in Part A. Doses will be taken either with or without food according to the results of Part B of the study.
- Group C1 (N=8): IAMA-6 Dose X (N=6) or Placebo (N=2)
- Group C2 (N=8): IAMA-6 Dose Y (N=6) or Placebo (N=2)
- Group C3 (N=8): IAMA-6 Dose Z (N=6) or Placebo (N=2)
In each cohort, treatment will be randomly assigned, such that 2 participants (1 IAMA-6 and 1 placebo) will be dosed first, as sentinel subjects. If the safety and tolerability results are acceptable, based on any reaction or adverse events, after at least 72 hours, the 6 remaining participants will be randomly assigned treatment (5 IAMA-6 and 1 placebo) and dosed. There will be a 7 day follow up after last dosing for all participants followed by review of clinical and laboratory safety data before starting treatment of the next dose cohort.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A: Single Ascending Dose (SAD) | Experimental | Drug: IAMA-6, Drug: PlaceboSingle oral doses (6 dose cohorts) of IAMA-6 liquid suspension or placebo-to-match IAMA-6 liquid suspension in fasted participants |
| Part B: Food Effect (FE) | Experimental | Drug: IAMA-6Single oral dose (1 dose cohort) of IAMA-6 liquid suspension in fed participants |
| Part C: Multiple Ascending Dose (MAD) | Experimental | Drug: IAMA-6, Drug: PlaceboMultiple oral doses (3 dose cohorts) of IAMA-6 liquid suspension or placebo-to-match IAMA-6 liquid suspension for 7 days in fasted or fed participants |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IAMA-6IAMA-6 liquid suspension | Drug | Part A: Single Ascending Dose (SAD), Part B: Food Effect (FE), Part C: Multiple Ascending Dose (MAD) |
| PlaceboPlacebo-to-match IAMA-6 liquid suspension | Drug | Part A: Single Ascending Dose (SAD), Part C: Multiple Ascending Dose (MAD) |
Primary outcome
Number of participants with adverse events (AEs)
Time frame: From time of the first dose to study completion, an average of 1 year
All AEs will be coded by Medical Dictionary for Regulatory Activities (MedDRA; Version 26.1 or later) System Organ Class and Preferred Term. The incidence of the following events will be summarized by treatment group and study part (i.e. Part A, Part B and Part C): * Treatment-emergent AEs (TEAEs). * TEAEs by severity. * TEAEs by causality. * Serious TEAEs.
Number of participants with serious adverse events (SAEs)
Time frame: From time of the first dose to study completion, an average of 1 year
All AEs will be coded by Medical Dictionary for Regulatory Activities (MedDRA; Version 26.1 or later) System Organ Class and Preferred Term. The incidence of the following events will be summarized by treatment group and study part (i.e. Part A, Part B and Part C): * Treatment-emergent AEs (TEAEs). * TEAEs by severity. * TEAEs by causality. * Serious TEAEs.
Number of participants with physical examination abnormalities
Time frame: Part A: Baseline and Day 8; Part B: Day 8; Part C: Baseline and Day 14
Physical examinations and mean changes from baseline (when applicable) will be descriptively summarized by treatment group and study part (i.e. Part A, Part B and Part C).
Number of participants with vital sign abnormalities
Time frame: Part A: Baseline and Days 1, 2 and 8; Part B: Days 1, 2 and 8; Part C: Baseline and Days 1-8 and 14
Vital sign parameters and mean changes from baseline (when applicable) will be descriptively summarized by treatment group and study part (i.e. Part A, Part B and Part C).
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Part A: Baseline and Days 1, 2 and 8; Part B: Days 1, 2 and 8; Part C: Baseline and Days 1-8 and 14
Electrocardiogram measurements and mean changes from baseline will be descriptively summarized by treatment group and study part (i.e. Part A, Part B and Part C).
Number of participants with clinical laboratory abnormalities
Time frame: Through study completion, an average of 1 year
Clinical laboratory test parameters and mean changes from baseline will be descriptively summarized by treatment group and study part (i.e. Part A, Part B and Part C).
Number of participants with hearing abnormalities
Time frame: Part C: Screening and Day 6
The results of the hearing tests (Part C) will be descriptively summarized by timepoint and the change vs baseline (when applicable) will also be analysed. Hearing tests performed: High Frequency Audiometry (HFA) and Pure Tone Audiometry (PTA).
11 secondary outcomes
Cmax pharmacokinetic (PK) parameter of IAMA-6 following single and multiple oral doses
Time frame: Parts A and B: Day 1, Day 2 and Day 3; Part C: Day 1 Day 2, Day 7, Day 8 and Day 9
Tmax pharmacokinetic (PK) parameter of IAMA-6 following single and multiple oral doses
Time frame: Parts A and B: Day 1, Day 2 and Day 3; Part C: Day 1 Day 2, Day 7, Day 8 and Day 9
T1/2 pharmacokinetic (PK) parameter of IAMA-6 following single and multiple oral doses
Time frame: Parts A and B: Day 1, Day 2 and Day 3; Part C: Day 1 Day 2, Day 7, Day 8 and Day 9
AUC(0-t) and AUCτ pharmacokinetic (PK) parameters of IAMA-6 following single and multiple oral doses
Time frame: Parts A and B: Day 1, Day 2 and Day 3; Part C: Day 1 Day 2, Day 7, Day 8 and Day 9
Vd pharmacokinetic (PK) parameters of IAMA-6 following single and multiple oral doses
Time frame: Parts A and B: Day 1, Day 2 and Day 3; Part C: Day 1 Day 2, Day 7, Day 8 and Day 9
CL pharmacokinetic (PK) parameters of IAMA-6 following single and multiple oral doses
Time frame: Parts A and B: Day 1, Day 2 and Day 3; Part C: Day 1 Day 2, Day 7, Day 8 and Day 9
λz pharmacokinetic (PK) parameters of IAMA-6 following single and multiple oral doses
Time frame: Parts A and B: Day 1, Day 2 and Day 3; Part C: Day 1 Day 2, Day 7, Day 8 and Day 9
Urine volume
Time frame: Before treatment (Day -1) and after treatment (Day 1 in Part A and Day 7 in Part C) for a 24-hour period
Na+ excretion
Time frame: Before treatment (Day -1) and after treatment (Day 1 in Part A and Day 7 in Part C) for a 24-hour period
K+ excretion
Time frame: Before treatment (Day -1) and after treatment (Day 1 in Part A and Day 7 in Part C) for a 24-hour period
Sleep assessment
Time frame: Day 2 (Parts A, B, C), Days 8 and 9 (Part C)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano Milleri, MD principal investigator
Centro Ricerche Cliniche di Verona srl
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IAMA-6 in people with Neurodevelopmental Disorders, run by Iama Therapeutics S.r.l. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (AEs) (time frame: From time of the first dose to study completion, an average of 1 year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.