CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 76 enrolled
Drug / intervention
CTH120 +1 moredrug
Likely dose
CTH120 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06480968
NCT06480968Phase 1Completed
CompareCT.gov

Safety and Tolerability of CTH120, First-in-human Phase I Study Encompassing Three Parts: Single and Multiple Ascending Doses and Potential Food Interaction

Connecta Therapeutics, S.L.·interventional·Posted Jul 1, 2024·Updated Jan 23, 2025

In Brief

A Phase 1 clinical trial evaluating CTH120 and Placebo for Fragile X Syndrome. Completed, enrolled 76 participants across 1 site.

Detailed Summary

The purpose of this First-in-Human Phase I study is to investigate the safety, tolerability and pharmacokinetics of CTH120 in adult healthy volunteers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFragile X Syndrome
CountriesSpain
CollaboratorsHospital del Mar Research Institute (IMIM), Adknoma Health Research, Ministry of Science and Innovation, Spain

Timeline

Phase 1CompletedFinished
202420252026
First PostedJul 1, 2024
Enrollment StartJun 23, 2023
Primary CompletionNov 11, 2024
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 2.0 years ago

Interventions

CTH120drug

FIH-CTH120-SAD: Each independent cohort of 8 subjects (placebo=2 and CTH120=6 per dose) will receive a single administration of CTH120 or placebo. Four consecutive dose levels (20 mg/day, 40 mg/day, 85 mg/day and 160 mg/day) are planned. If no significant clinical adverse events are observed in the FIH-CTH120-SAD phase, an additional 5th cohort will be recruited to conduct the 5th dose level. FIH-CTH120-MAD: Each independent cohort of 8 subjects (placebo=2 and CTH120=6 per dose) will receive a daily administration of CTH120 or placebo for 7 days. Three consecutive dose levels are planned. The starting dose will be confirmed following the observed results of FIH-CTH120-SAD. FIH-CTH120-FI: One dosage of CTH120 will be assessed in 12 healthy male and female subjects in two conditions (Fed and Fasting). Subjects will be randomly assigned to 2 sequences: 6 subjects in a sequence "fed then fasting condition", 6 subjects in the reverse sequence ("fasting, then fed condition").

Placeboother

FIH-CTH120-SAD: Each independent cohort of 8 subjects (placebo=2 and CTH120=6 per dose) will receive a single administration of CTH120 or placebo. Four consecutive dose levels (20 mg/day, 40 mg/day, 85 mg/day and 160 mg/day) are planned. If no significant clinical adverse events are observed in the FIH-CTH120-SAD phase, an additional 5th cohort will be recruited to conduct the 5th dose level. FIH-CTH120-MAD: Each independent cohort of 8 subjects (placebo=2 and CTH120=6 per dose) will receive a daily administration of CTH120 or placebo for 7 days. Three consecutive dose levels are planned. The starting dose will be confirmed following the observed results of FIH-CTH120-SAD.