First-in-Human Trial of Oral AN2-502998 (NCT07024589) | Clinical Trial Compass
CompletedPhase 1
First-in-Human Trial of Oral AN2-502998
Australia72 participantsStarted 2025-08-04
Plain-language summary
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
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. 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:
✓. 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:
Exclusion criteria
✕. History of significant sensitivity to any drug, including any excipients used in AN2-502998
✕. Requirement for any over-the-counter and/or prescription medication, vitamins and/or herbal supplements
✕. 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
✕. 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
✕. If female, is pregnant or breastfeeding
✕. Positive test result for HBsAg, HCV Ab, HIV Ab, or HIV Ag at Screening; negative HIV status will be confirmed at Screening
✕. ALT, AST, or total bilirubin with direct bilirubin \>ULN for the reference laboratory at Screening
✕. CrCl (Cockcroft-Gault formula), Hgb, Hct, WBC, neutrophil, or platelet count \<LLN for the reference laboratory at Screening, unless deemed not CS by the Investigator
What they're measuring
1
Evaluate the Incidence of Treatment Emergent Adverse Events at Baseline and Through Study Completion for a Single Dose
Timeframe: Day 1 through last follow-up (9 Days after single dose)
2
Evaluate Physical Examination Abnormalities from Baseline Through Study Completion for a Single Dose
Timeframe: Day 1 through last follow-up (9 Days after single dose)
3
Evaluate Change in Vital Signs from Baseline Through Study Completion for a Single Dose
Timeframe: Day 1 through last follow-up (9 Days after single dose)
4
Evaluate Changes in 12-lead ECG Measurements from Baseline Through Study Completion for a Single Dose
Timeframe: Day 1 through last follow-up (9 Days after single dose)
5
Evaluate Changes in Clinical Laboratory Tests from Baseline Through Study Completion for a Single Dose
Timeframe: Day 1 through last follow-up (9 Days after single dose)
6
Evaluate the Incidence of Treatment Emergent Adverse Events at Baseline and Through Study Completion for Multiple Doses
Timeframe: Day 1 through last follow-up (10 Days after last dose)
7
Evaluate Physical Examination Abnormalities from Baseline Through Study Completion for Multiple Doses