CompletedPhase 1

Multiple Ascending Dose Study of TMP-301 in Healthy Subjects

United States30 participantsStarted 2023-01-06

Plain-language 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.

Who can participate

Age range18 Years – 59 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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.

What they're measuring

Number of Treatment-Emergent Adverse Events (Safety and Tolerability)

Timeframe: Within each cohort from screening to end of the follow up period up to 25 days

Trial details

NCT IDNCT06025396

SponsorTempero Bio, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-22

Results submitted2025-03-14

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