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TMP-301 for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Tempero Bio, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within each cohort, urine will be collected on day 1 (0 to 4 hours, 4 to 8 hours, 8 to 12 hours, and 12 - 24 hours) and day 14 (0 to 4 hours, 4 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 48 hours (day 15), and 48 - 72 hours (day 16)).
Awards & highlights

Study Summary

This trial studies the safety of a new drug and how it is processed by the body in healthy people.

Who is the study for?
This trial is for healthy adults, aged 18-59, weighing at least 50 kg with a BMI of 18.5 to 32. They must not smoke or use nicotine and should avoid caffeine during the study. Women must be postmenopausal or surgically sterile; men must agree to contraception or be sterile. Participants can't have significant medical conditions, drug dependencies, or take certain medications.Check my eligibility
What is being tested?
The trial tests TMP-301's safety and how the body processes it in multiple doses compared to a placebo (a substance with no therapeutic effect). It's randomized and controlled: some people get TMP-301 while others get the placebo without knowing which one they receive.See study design
What are the potential side effects?
While specific side effects are not listed for TMP-301 as it is under investigation, common side effects in such trials may include nausea, headaches, dizziness, fatigue, allergic reactions or skin irritation at the site of administration.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within each cohort, urine will be collected on day 1 (0 to 4 hours, 4 to 8 hours, 8 to 12 hours, and 12 - 24 hours) and day 14 (0 to 4 hours, 4 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 48 hours (day 15), and 48 - 72 hours (day 16)).
This trial's timeline: 3 weeks for screening, Varies for treatment, and within each cohort, urine will be collected on day 1 (0 to 4 hours, 4 to 8 hours, 8 to 12 hours, and 12 - 24 hours) and day 14 (0 to 4 hours, 4 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 48 hours (day 15), and 48 - 72 hours (day 16)). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Secondary outcome measures
Plasma levels TMP 301
Other outcome measures
Caffeine and paraxanthine concentration as a marker of CYP1A2 activity
Presence of TMP-301 or metabolites in Urine

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active TMP-301Experimental Treatment1 Intervention
Cohort 1= 50mg, capsules form, one capsule - two times per day - total 100mg/day; Cohort 2= 50mg, capsule form, 1 capsules - one time per day- total 50mg/day Cohort 3= 50mg, capsule form, 2 capsules - one time per day- total 100mg/day; Cohort 4 = Dose Titration: 50mg, capsule form, 1 capsules - one time per day - total 50 mg/day - on Days 1-7; and 50 mg, capsule form, 2 capsules - one time per day - total 100mg/day - on Days 8-14; Each cohort duration is 14 days of dosing
Group II: PlaceboPlacebo Group1 Intervention
Cohort 1= Placebo, capsules form, one capsule - two times per day; Cohort 2= Placebo, capsule form, 1 capsules - one time per day; Cohort 3= Placebo, capsule form, 2 capsules - one time per day; Cohort 4 = Dose Titration: Placebo, capsule form, 1 capsules - one time per day - on Days 1-7; and Placebo, capsule form, 2 capsules - one time per day - on Days 8-14; Each cohort duration is 14 days of dosing
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TMP-301
2023
Completed Phase 1
~30

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Tempero Bio, Inc.Lead Sponsor
National Institute on Drug Abuse (NIDA)NIH
2,465 Previous Clinical Trials
2,618,603 Total Patients Enrolled
Dan Meyers, MDStudy DirectorCMO, Tempero Bio
1 Previous Clinical Trials
675 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being accepted into this experiment?

"Affirmative. Clinicaltrials.gov records show that this clinical investigation commenced on January 6th 2023 and is actively searching for applicants to participate in the study, with 32 volunteers necessary from a single medical center."

Answered by AI

Is this medical trial open to enrollment at present?

"That is correct. Based on the information available through clinicaltrials.gov, this research trial which was originally posted in June of 2023 is actively recruiting participants. 32 people are needed to be recruited from 1 medical site."

Answered by AI

What measures have been taken to ensure the safety of Active TMP-301 in humans?

"There is minimal clinical data confirming the safety and efficacy of Active TMP-301, so it was accorded a score of 1."

Answered by AI

Is it possible to partake in this clinical research?

"Requirements for inclusion in this trial dictate that individuals must have a history of substance use disorder and should be within the age range 18 to 59. A total of 32 participants are being recruited."

Answered by AI

Does this trial accommodate senior citizens aged 55 and over?

"The conditions of participation for this clinical trial necessitate that all participants are 18-59 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Multiple Ascending Dose Study of TMP-301 in Healthy Subjects
2023. "Multiple Ascending Dose Study of TMP-301 in Healthy Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06025396.
~13 spots leftby Apr 2025
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