NCT06025396

Multiple Ascending Dose Study of TMP-301 in Healthy Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Tempero Bio, Inc. · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study will be a randomized, double-blind, placebo controlled, fixed sequence, MAD study. The study will be conducted in a single clinical research unit (CRU). The study will consist of up to 4 cohorts. Subjects will only participate in 1 cohort. Screening will occur within approximately 28 days prior to the first scheduled study drug administration. Subjects who meet all inclusion criteria and none of the exclusion criteria and who consent to participation will be admitted to the CRU for baseline evaluations prior to dosing. Subjects will be fasted overnight for 10 hours prior to the morning dose, followed by a 2 hour fast. Subjects are fasted for 2 hours prior to dosing and 2 hours following the evening dose for the cohort 1 (50 mg bid). Subjects will be discharged from the CRU on Day 18. Subjects will return to the CRU on Day 25 for a follow-up visit and EOS procedures. Caffeine (100 mg) will be included as probe CYP1A2 substrate in cohort 2 and subsequent cohorts. The maximum duration of subject participation, including Screening, will be approximately 53 days. Subjects who terminate the study early will perform follow-up procedures at the time of Early Termination.

Conditions

• Cocaine Use Disorder
• Substance Use Disorders
• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Cohort 1 - TMP-301	50 mg BID Fasted
DRUG	Placebo	Multiple ascending dose comparator
DRUG	Cohort 2 - TMP-301	50 mg QD Fasted
DRUG	Cohort 3 - TMP-301	50 mg QD Fed
DRUG	Cohort 4 - TMP-301	25 mg QD Fed

Timeline

• Start date: 2023-01-06
• Primary completion: 2023-12-22
• Completion: 2024-01-02
• First posted: 2023-09-06
• Last updated: 2025-07-29
• Results posted: 2025-07-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study