CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 30 enrolled
Drug / intervention
Cohort 1 - TMP-301 +4 moredrug
Likely dose
Cohort 1 - TMP-301 50 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/NCT06025396
NCT06025396Phase 1Completed
CompareCT.gov

A Phase 1, Randomized, Placebo-Controlled, Multiple Ascending Dose (MAD) Study To Evaluate The Safety, Tolerability, and Pharmacokinetics of TMP-301 in Healthy Subjects

Tempero Bio, Inc.·interventional·Posted Sep 6, 2023·Updated Jul 29, 2025

In Brief

A Phase 1 clinical trial evaluating Cohort 1 - TMP-301, Placebo, and 3 other interventions for Cocaine Use Disorder and 2 related conditions. Completed, enrolled 30 participants across 1 site.

Detailed Summary

A PHASE 1, RANDOMIZED, PLACEBO CONTROLLED, MULTIPLE ASCENDING DOSE (MAD) STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF TMP-301 IN HEALTHY SUBJECTS.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCocaine Use Disorder, Substance Use Disorders, Healthy Volunteers
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA)

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedSep 6, 2023
Enrollment StartJan 6, 2023
Primary CompletionDec 22, 2023
Study CompletionJan 2, 2024
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 2.8 years ago

Interventions

Cohort 1 - TMP-301drug

50 mg BID Fasted

Placebodrug

Multiple ascending dose comparator

Cohort 2 - TMP-301drug

50 mg QD Fasted

Cohort 3 - TMP-301drug

50 mg QD Fed

Cohort 4 - TMP-301drug

25 mg QD Fed