IAMA-6 Oral Dose Study in Healthy Adults

Neurodevelopmental Disorders Clinical Trial

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

Status Recruiting

Clinical 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.

Clinical Trial 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):

1. Group A1 (N=8): IAMA-6 Dose 1 (N=6) or Placebo (N=2)

2. Group A2 (N=8): IAMA-6 Dose 2 (N=6) or Placebo (N=2)

3. Group A3 (N=8): IAMA-6 Dose 3 (N=6) or Placebo (N=2)

4. Group A4 (N=8): IAMA-6 Dose 4 (N=6) or Placebo (N=2)

5. Group A5 (N=8): IAMA-6 Dose 5 (N=6) or Placebo (N=2)

6. 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.

1. Group C1 (N=8): IAMA-6 Dose X (N=6) or Placebo (N=2)

2. Group C2 (N=8): IAMA-6 Dose Y (N=6) or Placebo (N=2)

3. 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. ;

Related Conditions & MeSH terms

• Neurodevelopmental Disorders

• NCT number: NCT06300398
• Study type: Interventional
• Source: Iama Therapeutics S.r.l.
• Contact: Ciro Spedaliere
• Phone: +39 3293532484
• Email: ciro.spedaliere@iamatherapeutics.com
• Status: Recruiting
• Phase: Phase 1
• Start date: January 8, 2024
• Completion date: September 2024