Cocaine Use DisorderPhase 1NCT06025396
Multiple Ascending Dose Study of TMP-301 in Healthy Subjects
A Phase 1 study testing Cohort 1 - TMP-301, Cohort 2 - TMP-301 and Cohort 3 - TMP-301 in people with Cocaine Use Disorder and Substance Use Disorders, run by Tempero Bio, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Cocaine Use Disorder, Substance Use Disorders, Healthy Volunteers
- What is being tested?
- Cohort 1 - TMP-301, Cohort 2 - TMP-301 and Cohort 3 - TMP-301
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2023to 2 Jan 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of signed and dated informed consent form (ICF)
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Healthy adult male or female
- If male, meets one of the following criteria: a) Is able to procreate and agrees to use one of the accepted contraceptive regimens and not to donate sperm from the first study drug administration to at least 90 days after the follow-up visit. An acceptable method of contraception includes one of the following: Abstinence from heterosexual intercourse, or Male condom with spermicide or male condom with a vaginal spermicide (gel, foam, or suppository); or b) Is unable to procreate; defined as surgically sterile (ie, has undergone a vasectomy at least 180 days prior to the first study drug administration)
- If female, meets one of the following criteria: (1) Physiological postmenopausal status, defined as the following: a) absence of menses for at least 12 months prior to the first study drug administration (without an alternative medical condition); and b) Follicle stimulating hormone (FSH) levels ≥ 40 mIU/mL at Screening; Or (2) Surgical postmenopausal status, defined as the following: a) bilateral oophorectomy, salpingectomy, or tubal ligation; hysterectomy
- Aged at least 18 years but not older than 59 years, inclusive, at the time of informed consent
Show all 13Show fewer
- Body mass index (BMI) within 18.5 kg/m2 to 32.0 kg/m2, inclusively
- Minimum body weight of at least 50.0 kg
- Non- or ex smoker (An ex smoker is defined as someone who completely stopped using nicotine products for at least 90 days prior to the first study drug administration)
- Must be willing to abstain from drinking coffee or caffeine containing beverages during the study, except where part of the study procedures
- Has supine blood pressure and pulse rate within the following ranges after 5 minutes rest: systolic blood pressure 90 to 140 mmHg, diastolic blood pressure 50 to 90 mmHg, and pulse rate 45 to 90 bpm at Screening and on Day -1
- Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or ECG, as determined by an Investigator
- Has clinical laboratory test results within the reference ranges of the testing laboratory, with the exception of results outside the reference ranges that are deemed not clinically significant by the Investigator (or designee) at Screening and check-in *
Who cannot join
- Female who is lactating
- Female who is pregnant according to the pregnancy test at Screening or prior to the first study drug administration
- Female using the following systemic contraceptives: oral, patch or vaginal ring, in the 28 days prior to the first study drug administration and during the study
- Female using hormone replacement therapy in the 28 days prior to the first study drug administration and during the study
- Female using the following systemic contraceptives: injections or implant, or hormone releasing intrauterine device in the 13 weeks prior to the first study drug administration and during the study
- Drinking excessive amounts of tea, coffee, chocolate, and/or beverage or eating food containing caffeine (> 2 cups/day)
Show all 37Show fewer
- Use of tobacco or nicotine containing products (including but not limited to; cigarettes, electronic cigarettes, pipes, cigars, chewing tobacco, nicotine patch, or nicotine gum) within 90 days prior to the first study drug administration and the inability to abstain from nicotine containing products until the follow-up visit.
- Past or current history of any mental, behavioral, or neurodevelopmental disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) or significant risk of developing a psychosis (assessed by PRIME screen) or a personal history of psychotic symptoms (hallucinations or delusions) with or without a formal psychiatric diagnosis. Subjects with family history of significant mental, behavioral, or neurodevelopmental disorders unless determined by the Investigator (or designee) and agreed by the Medical Monitor to be non-clinically significant (NCS) will be excluded.
- History or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, gastrointestinal, neurological, respiratory, or endocrine disorder, unless determined by the Investigator (or designee) and agreed by the Medical Monitor to be NCS
- Active or history of cardiovascular or cerebrovascular disease, including hypertension, angina, ischemic heart disease, transient ischemic attacks, bundle branch block, evidence of myocardial ischemia, stroke, and peripheral arterial disease sufficient to cause symptoms and/or require therapy to maintain stable status
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee)
- Active neoplastic disease or history of any neoplastic disease within 5 years of Screening (except for basal or squamous cell carcinoma of the skin or carcinoma in situ that has been definitely treated with standard of care)
- Active infection (eg, sepsis, pneumonia, abscess) or a serious infection (eg, resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to dosing
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed)
- Any of the following at Screening and/or prior to the first study drug administration:
- QT interval corrected for heart rate using Fridericia's method (QTcF) > 450 ms confirmed by repeat measurement
- QRS duration > 110 ms confirmed by confirmed by repeat measurement
- PR interval > 220 ms confirmed by repeat measurement
- Findings which would make QTc measurements difficult or QTc data uninterpretable
- History of additional risk factors for torsades de pointe (eg, heart failure, hypokalemia, family history of long QT syndrome)
- Maintenance therapy with any drug or significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
- Positive test result for alcohol, cotinine, and/or drugs of abuse at Screening or prior to the first drug administration
- Positive screening results to HIV Ag/Ab combo, hepatitis B surface antigen or hepatitis C virus tests
- Any other clinically significant abnormalities in laboratory test results at Screening that would, in the opinion of an Investigator, increase the subject's risk of participation, jeopardize complete participation in the study, or compromise interpretation of study data
- Intake of an IP in the 28 days prior to the first study drug administration
- Use of any prescription drugs in the 28 days prior to the first study drug administration, that in the opinion of an Investigator would put into question the status of the participant as healthy
- Use of St. John's wort in the 28 days prior to the first study drug administration and during the study
- Consumption of any foods or beverages which alter CYP1A2 activity, e.g., barbecued food or cruciferous vegetables, such as broccoli and cauliflower, within 14 days prior to (first) check-in (a list of prohibited foods will be provided to subjects)
- Consumption of any foods or beverages containing Seville-type oranges, grapefruit, or poppy seeds within 7 days prior to (first) check-in
- Receipt of blood products within 2 months prior to check-in
- Donation of 1 unit of blood to American Red Cross or equivalent organization or donation of over 500 mL of blood in the 56 days prior to the first study drug administration
- Donation of plasma in the 7 days prior to the first study drug administration
- Poor peripheral venous access
- History or significant hypersensitivity to TMP301 or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
- Subjects who, in the opinion of the Investigator (or designee; including input from subjects' general practitioner, as applicable), should not participate in this study
- Subject hospitalized for any reason in a period of 30 days before the start of the study
- Subjects who are investigational site staff members or directly involved in the conduct of the study and their family members or subjects who are employed by the Sponsor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Placebo-Controlled, Multiple Ascending Dose (MAD) Study To Evaluate The Safety, Tolerability, and Pharmacokinetics 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.
Read the 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.
- Being tested
- Cohort 1 - TMP-301, Placebo, Cohort 2 - TMP-301, Cohort 3 - TMP-301, Cohort 4 - TMP-301
- Keywords
- drug addiction, cocaine use disorder, cocaine dependance, TMP-301, cocaine use, CUD, drug abuse
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Active TMP-301 | Experimental | 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 Receives: Drug: Cohort 1 - TMP-301; Drug: Cohort 2 - TMP-301; Drug: Cohort 3 - TMP-301; Drug: Cohort 4 - TMP-301 |
| Placebo | Placebo comparator | 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Treatment-Emergent Adverse Events (Safety and Tolerability)
Occurence of Adverse Events, spontaneously reported and identified through clinical laboratory tests, vital sign measurements, ECG, physical exams and psychiatric assessments.
Measured: Within each cohort from screening to end of the follow up period up to 25 days
Secondary outcomes (15)
To Evaluate the Plasma Area Under the Curve (AUC) 0-12 Hours After First Dose of TMP-301
0-12 hours post-dose on Day 1, twice daily dosing
Measured: Day 1
To Evaluate the Plasma Area Under the Curve (AUC) 0-24 Hours After First Dose of TMP-301
Measured: Day 1
Maximum Plasma Concentration (Cmax) of TMP-301
Measured: Day 1
Time to Maximum Plasma Concentration (Tmax) of TMP-301
Measured: Day 1
Plasma Concentration of TMP-301 at 12 Hours After First Dose (C12)
Measured: Day 1
Plasma Concentration of TMP-301 at 24 Hours After First Dose (C24)
Measured: Day 1
Maximum Plasma Concentration (Cmax) of TMP-301 at Steady State
Measured: Day 14
Average Plasma Concentration of TMP-301 at 12 Hours After Last Dose (C12)
Measured: Day 14
Time to Maximum Plasma Concentration (Tmax) of TMP-301 at Steady State
Measured: Day 14
Minimum Drug Concentration (Cmin) of TMP-301 at Steady State
Measured: Day 14
Area Under the Curve (Exposure) at Steady-state( AUC0_tau,ss), Over the Dosing Interval.
Measured: Day 14
Plasma Concentration of TMP-301 at 24 Hours After Last Dose at Steady State (C24, ss)
Measured: Day 14
Terminal Half-life (T1/2) of TMP-301
Measured: Day 14
Apparent Total Plasma Clearance of TMP-301 After Extravascular Administration (CL/F)
Measured: Day 14
Apparent Volume of Distribution of TMP-301 at Steady State (Vz/F)
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start6 Jan 2023
- Primary completion22 Dec 2023
- Study completion2 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cocaine Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- sequential assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tempero Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Dan Meyers, MD, Study director, CMO, Tempero Bio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06025396
- Sponsor's protocol ID
- TMP-301-HNV-101
- Other IDs
- U01DA057118
- Status last verified
- Jul 2025
- First submitted
- 21 Aug 2023
- Last updated
- 29 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Placebo-Controlled, Multiple Ascending Dose (MAD) Study To Evaluate The Safety, Tolerability, and Pharmacokinetics of TMP-301 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06025396
- Acronym / sponsor ID
- TMP-301-HNV-101
- Keywords
- drug addiction, cocaine use disorder, cocaine dependance, TMP-301, cocaine use, CUD, drug abuse
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tempero Bio, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 6 Jan 2023 (actual)
- Primary completion
- 22 Dec 2023 (actual)
- Study completion
- 2 Jan 2024 (actual)
- First posted
- 6 Sep 2023 (actual)
- Results
- Posted 29 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- sequential assignment
| Arm | Type | Receives |
|---|---|---|
| Active TMP-301 | Experimental | Drug: Cohort 1 - TMP-301, Drug: Cohort 2 - TMP-301, Drug: Cohort 3 - TMP-301, Drug: Cohort 4 - TMP-301Cohort 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 |
| Placebo | Placebo comparator | Drug: PlaceboCohort 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 |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Provision of signed and dated informed consent form (ICF)
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Healthy adult male or female
- If male, meets one of the following criteria: a) Is able to procreate and agrees to use one of the accepted contraceptive regimens and not to donate sperm from the first study drug administration to at least 90 days after the follow-up visit. An acceptable method of contraception includes one of the following: Abstinence from heterosexual intercourse, or Male condom with spermicide or male condom with a vaginal spermicide (gel, foam, or suppository); or b) Is unable to procreate; defined as surgically sterile (ie, has undergone a vasectomy at least 180 days prior to the first study drug administration)
- If female, meets one of the following criteria: (1) Physiological postmenopausal status, defined as the following: a) absence of menses for at least 12 months prior to the first study drug administration (without an alternative medical condition); and b) Follicle stimulating hormone (FSH) levels ≥ 40 mIU/mL at Screening; Or (2) Surgical postmenopausal status, defined as the following: a) bilateral oophorectomy, salpingectomy, or tubal ligation; hysterectomy
Key exclusion criteria (37 listed)
- Female who is lactating
- Female who is pregnant according to the pregnancy test at Screening or prior to the first study drug administration
- Female using the following systemic contraceptives: oral, patch or vaginal ring, in the 28 days prior to the first study drug administration and during the study
- Female using hormone replacement therapy in the 28 days prior to the first study drug administration and during the study
- Female using the following systemic contraceptives: injections or implant, or hormone releasing intrauterine device in the 13 weeks prior to the first study drug administration and during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cohort 1 - TMP-30150 mg BID Fasted | Drug | Active TMP-301 |
| PlaceboMultiple ascending dose comparator | Drug | Placebo |
| Cohort 2 - TMP-30150 mg QD Fasted | Drug | Active TMP-301 |
| Cohort 3 - TMP-30150 mg QD Fed | Drug | Active TMP-301 |
| Cohort 4 - TMP-30125 mg QD Fed | Drug | Active TMP-301 |
Primary outcome
Number of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time frame: Within each cohort from screening to end of the follow up period up to 25 days
Occurence of Adverse Events, spontaneously reported and identified through clinical laboratory tests, vital sign measurements, ECG, physical exams and psychiatric assessments.
15 secondary outcomes
To Evaluate the Plasma Area Under the Curve (AUC) 0-12 Hours After First Dose of TMP-301
Time frame: Day 1
To Evaluate the Plasma Area Under the Curve (AUC) 0-24 Hours After First Dose of TMP-301
Time frame: Day 1
Maximum Plasma Concentration (Cmax) of TMP-301
Time frame: Day 1
Time to Maximum Plasma Concentration (Tmax) of TMP-301
Time frame: Day 1
Plasma Concentration of TMP-301 at 12 Hours After First Dose (C12)
Time frame: Day 1
Plasma Concentration of TMP-301 at 24 Hours After First Dose (C24)
Time frame: Day 1
Maximum Plasma Concentration (Cmax) of TMP-301 at Steady State
Time frame: Day 14
Average Plasma Concentration of TMP-301 at 12 Hours After Last Dose (C12)
Time frame: Day 14
Time to Maximum Plasma Concentration (Tmax) of TMP-301 at Steady State
Time frame: Day 14
Minimum Drug Concentration (Cmin) of TMP-301 at Steady State
Time frame: Day 14
Area Under the Curve (Exposure) at Steady-state( AUC0_tau,ss), Over the Dosing Interval.
Time frame: Day 14
Plasma Concentration of TMP-301 at 24 Hours After Last Dose at Steady State (C24, ss)
Time frame: Day 14
Terminal Half-life (T1/2) of TMP-301
Time frame: Day 14
Apparent Total Plasma Clearance of TMP-301 After Extravascular Administration (CL/F)
Time frame: Day 14
Apparent Volume of Distribution of TMP-301 at Steady State (Vz/F)
Time frame: Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Meyers, MD study director
CMO, Tempero Bio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cohort 1 - TMP-301, Cohort 2 - TMP-301 and Cohort 3 - TMP-301 in people with Cocaine Use Disorder and Substance Use Disorders, run by Tempero Bio, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Treatment-Emergent Adverse Events (Safety and Tolerability) (time frame: Within each cohort from screening to end of the follow up period up to 25 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.