Multiple Ascending Dose Study of TMP-301 in Healthy Subjects

Completed · Phase 1 · Has a placebo group

Conditions studied: Cocaine Use Disorder, Substance Use Disorders, Healthy Volunteers

In brief

A PHASE 1, RANDOMIZED, PLACEBO CONTROLLED, MULTIPLE ASCENDING DOSE (MAD) STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF TMP-301 IN HEALTHY SUBJECTS.

Key facts

Study ID

NCT06025396

Run by

Tempero Bio, Inc.

People needed

30

Starts

2023-01-06

Expected to finish

2024-01-02

Last updated by the study team

2025-07-29

Who can join

Age: 18 and older, up to 59. Sex: any. Healthy volunteers: accepted.

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:
• 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

Where it is running

• Altasciences — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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