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Intranasal Administration of Dodecyl Creatine Ester (CBT101) in Healthy Male Subjects

NCT07050316 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-03-27

No results posted yet for this study

Summary

A Phase 1, Randomized, Double-Blinded, Placebo-Controlled study to Evaluate the Safety, Tolerability,and Pharmacokinetics of Single and Multiple Ascending Doses of CBT101 given intranasally in Healthy Male Subjects.

Conditions

  • Neurologic Diseases, General

Interventions

DRUG

CBT101

Part 1 (SAD): at the morning * Cohort 1: 1 puff in each nostril (total 2 puffs), total 4.2 mg * Cohort 2: 2 puffs in each nostril (total 4 puffs), total 8.4 mg * Cohort 3: 3 puffs in each nostril (total 6 puffs), total 12.6 mg Part 2 (MAD): * Cohort 4: 1 puff per nostril/day (total 2 puffs/day), total 4.2 mg/day (morning) * Cohort 5: 2 puffs per nostril/day (total 4 puffs/day), total 8.4 mg/day (morning and evening) * Cohort 6: 3 puffs per nostril/day (total 6 puffs/day), total 12.6 mg/day (morning, midday and evening)

DRUG

Placebo

Part 1 (SAD): at the morning * Cohort 1: 1 puff in each nostril (total 2 puffs), total 4.2 mg * Cohort 2: 2 puffs in each nostril (total 4 puffs), total 8.4 mg * Cohort 3: 3 puffs in each nostril (total 6 puffs), total 12.6 mg Part 2 (MAD): * Cohort 4: 1 puff per nostril/day (total 2 puffs/day), total 4.2 mg/day (morning) * Cohort 5: 2 puffs per nostril/day (total 4 puffs/day), total 8.4 mg/day (morning and evening) * Cohort 6: 3 puffs per nostril/day (total 6 puffs/day), total 12.6 mg/day (morning, midday and evening)

Sponsors & Collaborators

  • Eurofins Optimed

    collaborator INDUSTRY

  • Ceres Brain Therapeutics

    lead OTHER

Principal Investigators

  • Thomas JOUDINAUD · Ceres Brain Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-14
Primary Completion
2025-09-26
Completion
2025-09-26

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07050316 on ClinicalTrials.gov