IAMA-6 Oral Dose Study in Healthy Adults

NCT06300398 | Completed Phase 1

• 1 other identifier: ECS_IAMA23_0101
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neurodevelopmental Disorders

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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).

  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).

  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).

  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).

  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).

  Part C: Screening and Day 6

Secondary Outcomes (11)

• Cmax pharmacokinetic (PK) parameter of IAMA-6 following single and multiple oral doses

  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

  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

  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

  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

  Parts A and B: Day 1, Day 2 and Day 3; Part C: Day 1 Day 2, Day 7, Day 8 and Day 9

Study Arms (3)

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

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

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

Drug: IAMA-6; Drug: Placebo

Interventions

IAMA-6 DRUG

IAMA-6 liquid suspension

Part A: Single Ascending Dose (SAD); Part B: Food Effect (FE); Part C: Multiple Ascending Dose (MAD)

Placebo DRUG

Placebo-to-match IAMA-6 liquid suspension

Part A: Single Ascending Dose (SAD); Part C: Multiple Ascending Dose (MAD)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Iama Therapeutics S.r.l.: lead

Study Sites (1)

Centro Ricerche Cliniche Di Verona S.r.l.

Verona, Italy

Location

MeSH Terms

Conditions

Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Stefano Milleri, MD

  Centro Ricerche Cliniche di Verona srl

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 8, 2024
• Study Start: January 8, 2024
• Primary Completion: October 10, 2024
• Study Completion: November 20, 2024
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)