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Multiple Ascending Dose Study of TMP-301 in Healthy Subjects

NCT06025396 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-07-29

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Tempero Bio, Inc.

    lead INDUSTRY

Principal Investigators

  • Dan Meyers, MD · CMO, Tempero Bio

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-06
Primary Completion
2023-12-22
Completion
2024-01-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT06025396 on ClinicalTrials.gov