临床试验/NCT07024589

NCT07024589已完成1 期

A Phase 1, Single-Center, Randomized, Blinded, Placebo-Controlled Trial in Healthy Adults to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Oral AN2-502998

AN2 Therapeutics, Inc1 个研究点分布在 1 个国家目标入组 72 人开始时间: 2025年8月4日最近更新: 2026年4月30日

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: AN2 Therapeutics, Inc
入组人数: 72
试验地点: 1
主要终点: Characterize the PK Profile of AN2-502998: Time to Maximum Plasma Concentration

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

First-in-Human Phase 1, Single-Center, Randomized, Blinded, Placebo-Controlled Trial in Healthy Adults to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Oral AN2-502998

详细描述

First-in-human Phase 1, Single-Center, Randomized, Blinded, Placebo-Controlled Trial in Healthy Adults to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Oral AN2-502998

Part A (SAD; Groups SAD1-SAD6):

Part A is the Single Ascending Dose (SAD) portion of the trial that will be conducted in approximately 48 healthy adults in approximately 6 groups. Eight participants in each group will be randomized in a 6:2 ratio to receive a single dose of AN2-502998 or matching PBO, respectively (6 AN2-502998:2 PBO).

Part B (MAD; Groups MAD1-MAD3):

Part B is the Multiple Ascending Dose (MAD) portion of the trial that will be conducted in approximately 24 healthy adults in approximately 3 groups. Eight participants in each group will be randomized in a 6:2 ratio to receive multiple doses of AN2-502998 or matching PBO (6 AN2 502998:2 PBO) QD for 10 days.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Sequential
主要目的: Basic Science
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 55 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Male or female aged 18 to 55 years, inclusive, at Screening
•Willing and able to provide written informed consent
•Willing and able to comply with all trial assessments and adhere to the protocol schedule
•BMI between ≥18 and <32 kg/m2 (inclusive); BMI is calculated as weight measured in kilograms (kg) divided by the square of height measured in meters (m)
•If female, must:
•Be of nonchildbearing potential defined as either postmenopausal for ≥2 years or surgically sterile (bilateral salpingectomy, bilateral oophorectomy, or hysterectomy); postmenopausal is defined as amenorrheic for ≥1 year in the absence of other biological causes, age appropriate, and has a FSH level during Screening indicating a postmenopausal state; AND
•Have negative results for pregnancy tests performed as follows:
•i. Urine specimen obtained during Screening, and ii. Serum specimen obtained on Study Day -1
•If male and sexually active with a female of childbearing potential, must be surgically sterile or agree to practice at least 1 of the following effective forms of contraception up to 90 days after the last dose of study drug, starting with Study Day 1:
•Partner(s) using an IUD
•Partner(s) using oral, injected, or implanted methods of hormonal contraceptives
•Partner(s) with bilateral tubal occlusion
•Total abstinence from sexual intercourse as the preferred lifestyle of the participant; periodic abstinence is not acceptable
•If male, must agree to use a male condom during intercourse to avoid potential drug exposure to the partner up to 90 days after the last dose of study drug, starting with Study Day 1
•If female, must agree to use a male condom during heterosexual intercourse to avoid potential drug exposure to the partner up to 90 days after the last dose of study drug, starting with Study Day 1
•Agree to not donate sperm (males) or ova (females) from Screening until 90 days after the last dose of study drug
•Medically healthy with no significant clinical medical history, physical examination findings, laboratory results, vital signs, or 12-lead ECG findings, as deemed by the Investigator (or delegate)

排除标准

•1. History of significant sensitivity to any drug, including any excipients used in AN2-502998
•2. Requirement for any over-the-counter and/or prescription medication, vitamins and/or herbal supplements
•3. Use of any medications (prescription or over-the-counter), vitamins, and/or herbal supplements within the 2-week period prior to the first dose of study drug administration or within 5 half-lives of the respective medication, whichever is longer
•4. Receipt of any drug by injection, including vaccinations, within 30 days (for vaccinations) or a period defined by 5 half-lives, whichever is longer, prior to study drug administration
•5. If female, is pregnant or breastfeeding
•6. Positive test result for HBsAg, HCV Ab, HIV Ab, or HIV Ag at Screening; negative HIV status will be confirmed at Screening
•7. ALT, AST, or total bilirubin with direct bilirubin \>ULN for the reference laboratory at Screening
•8. CrCl (Cockcroft-Gault formula), Hgb, Hct, WBC, neutrophil, or platelet count \450 msec for females or \>430 msec for males at Screening
•11. Recent (3-month) history of drug or alcohol abuse that could preclude adherence to the protocol
•12. History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces \[150 mL\] of wine or 12 ounces \[360 mL\] of beer, or 1.5 ounces \[45 mL\] of hard liquor) within 6 months prior to Screening
•13. Positive screen for drugs of abuse, alcohol, or cotinine at Screening and Study Day -1
•14. History of seizures, diabetes, or cancer (except basal cell carcinoma of the skin)
•15. Current clinically significant cardiovascular, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic, neurologic or thyroid disease, or any uncontrolled medical illness or psychiatric disease or disorder
•16. Past history of epilepsy; any clinically significant cardiovascular, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic, neurologic, or thyroid disease; or any uncontrolled medical illness or psychiatric disease or disorder
•17. History of gastric surgery, vagotomy, bowel resection, cholecystectomy, or any surgical procedure or medical condition that might interfere with gastrointestinal motility, pH, or absorption
•18. Donation or loss of 550 mL or more blood volume (including plasmapheresis) within 4 weeks prior to study drug administration or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration
•19. Receipt of any investigational product within a period equal to 10 half-lives of the product, if known, or a minimum of 6 weeks prior to study drug administration
•20. Consumption of alcohol within the 72 hours prior to study drug administration
•21. Consumption of grapefruit, star fruit, Seville oranges, or products containing any of these ingredients within the 10-day period prior to study drug administration
•22. Use of inhaled nicotine, tobacco, or marijuana products within the 6 months prior to study drug administration
•23. Current enrollment in another clinical trial

研究组 & 干预措施

Single Ascending Dose (SAD)

Experimental

Participants will be randomized in a 3:1 ratio to receive a single dose of either AN2-502998 or placebo.

干预措施: Placebo (Drug)

Multiple Ascending Dose (MAD)

Experimental

Participants will be randomized in a 3:1 ratio to receive multiple doses of either AN2-502998 or placebo.

干预措施: Placebo (Drug)

Single Ascending Dose (SAD)

Experimental

Participants will be randomized in a 3:1 ratio to receive a single dose of either AN2-502998 or placebo.

干预措施: AN2-502998 (Drug)

Multiple Ascending Dose (MAD)

Experimental

Participants will be randomized in a 3:1 ratio to receive multiple doses of either AN2-502998 or placebo.

干预措施: AN2-502998 (Drug)

结局指标

主要结局

Characterize the PK Profile of AN2-502998: Time to Maximum Plasma Concentration

时间窗: Day 1 through 3 days after last dose

Determination the time to maximum plasma concentration (Tmax)

Characterize the PK Profile of AN2-502998: Terminal Half-Life

时间窗: Day 1 through 3 days after last dose

Determine the apparent terminal half-life (t½)

Characterize the PK Profile of AN2-502998: Area Under Plasma Concentration Curve

时间窗: Day 1 through 3 days after last dose

Area under plasma concentration-time curve from zero to a designated dosing interval

Characterize the PK Profile of AN2-502998: Apparent Plasma Clearance

时间窗: Day 1 through 3 days after last dose

Apparent plasma clearance of drug after extravascular administration CL/F

Evaluate Physical Examination Abnormalities from Baseline Through Study Completion for a Single Dose

时间窗: Day 1 through last follow-up (9 Days after single dose)

Incidence of physical exam abnormalities

Evaluate Change in Vital Signs from Baseline Through Study Completion for a Single Dose

时间窗: Day 1 through last follow-up (9 Days after single dose)

Incidence of changes in blood pressure, pulse, respiratory rate, and temperature

Evaluate Changes in 12-lead ECG Measurements from Baseline Through Study Completion for a Single Dose

时间窗: Day 1 through last follow-up (9 Days after single dose)

Incidence of changes in 12-lead ECG parameters from baseline

Evaluate Changes in Clinical Laboratory Tests from Baseline Through Study Completion for a Single Dose

时间窗: Day 1 through last follow-up (9 Days after single dose)

Incidence of changes in clinical laboratory measurements from baseline

Evaluate Physical Examination Abnormalities from Baseline Through Study Completion for Multiple Doses

时间窗: Day 1 through last follow-up (10 Days after last dose)

Incidence of physical exam abnormalities

Evaluate Change in Vital Signs from Baseline Through Study Completion for Multiple Doses

时间窗: Day 1 through last follow-up (10 Days after last dose)

Incidence of changes in blood pressure, pulse, respiratory rate, and temperature

Evaluate Changes in 12-lead ECG Measurements from Baseline Through Study Completion for Multiple Doses

时间窗: Day 1 through last follow-up (10 Days after last dose)

Incidence of changes in 12-lead ECG parameters from baseline

Evaluate Changes in Clinical Laboratory Tests from Baseline Through Study Completion for Multiple Doses

时间窗: Day 1 through last follow-up (10 Days after last dose)

Incidence of changes in clinical laboratory measurements from baseline

Characterize the PK Profile of AN2-502998: Maximum Plasma Concentration

时间窗: Day 1 through last follow-up (3 Days after last dose)

Determination of the maximum plasma concentration (Cmax)