Multiple Ascending Dose Study of TMP-301 in Healthy Subjects

NCT06025396 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: TMP-301-HNV-101U01DA057118
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Cocaine Use Disorder; Substance Use Disorders; Healthy Volunteers

Keywords

drug addiction; cocaine use disorder; cocaine dependance; TMP-301; cocaine use; CUD; drug abuse

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Day 1

• To Evaluate the Plasma Area Under the Curve (AUC) 0-24 Hours After First Dose of TMP-301

  Day 1

• Maximum Plasma Concentration (Cmax) of TMP-301

  Day 1

• Time to Maximum Plasma Concentration (Tmax) of TMP-301

  Day 1

• Plasma Concentration of TMP-301 at 12 Hours After First Dose (C12)

  Day 1

Study Arms (2)

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

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

Drug: Placebo

Interventions

Cohort 1 - TMP-301 DRUG

50 mg BID Fasted

Active TMP-301

Placebo DRUG

Multiple ascending dose comparator

Placebo

Cohort 2 - TMP-301 DRUG

50 mg QD Fasted

Active TMP-301

Cohort 3 - TMP-301 DRUG

50 mg QD Fed

Active TMP-301

Cohort 4 - TMP-301 DRUG

25 mg QD Fed

Active TMP-301

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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 \*

You may not qualify if:

• 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)
• 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:

Sponsors & Collaborators

• Tempero Bio, Inc.: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Altasciences

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Director, Clinical Operations
• Organization: Tempero Bio

TMP-301-HNV-101@Temperobio.com

510-250-4750

Study Officials

• Dan Meyers, MD

  CMO, Tempero Bio

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: sequential assignment

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: September 6, 2023
• Study Start: January 6, 2023
• Primary Completion: December 22, 2023
• Study Completion: January 2, 2024
• Last Updated: July 29, 2025
• Results First Posted: July 29, 2025

Record last verified: 2025-07

Locations

US (1)