ACTRN12618001989235CompletedPhase 1
A Randomized, Double-Blind, Multiple Ascending Dose Study to Assess theSafety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACH-0145228 in HealthyParticipants
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 61
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 25 Years to 55 Years (—)
- Sex
- All
Inclusion Criteria
- •1. Participant must be 25 to 55 years of age, inclusive, at the time of signing the informed consent.
- •2. Participants who are overtly healthy as determined by medical evaluation including detailed medical history, physical examination, blood pressure (BP) and heart rate measurements, 12-lead ECG, and clinical laboratory tests.
- •3. Body weight of at least 50 kg and body mass index (BMI) within the range of 18 to 30 kg/m2 (inclusive).
- •4. Male or Female
- •Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •Male subjects must agree to abstinence or use a condom when engaged in sexual activity, and agree to refrain from sperm donation, from check-in through at least 90 days after administration of study drug.
- •Male subjects' female partners of child-bearing potential must agree to use a highly effective form of contraception for the same time period.
- •Female participants must be of non-childbearing potential as defined by one of the following:
- •Surgical sterilization by hysterectomy removal of uterus), bilateral salpingo-oophorectomy (removal of both ovaries and fallopian tubes) or bilateral oophorectomy (removal of both ovaries) at least 6 months prior to dosing.
- •Post-menopausal with amenorrhea (absence of menstrual periods) for at least 1 year prior to dosing and follicle stimulating hormone (FSH) serum levels consistent with postmenopausal status.
- •5. Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
Exclusion Criteria
- •1. Have a history or clinically relevant evidence of current cardiovascular, pulmonary, hepatic (including biliary cholestasis or Gilbert's syndrome), renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disorders or conditions capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data
- •2. Have a history of febrile illness, or other evidence of infection, within 14 days prior to first study drug administration
- •3. Have a history of meningococcal infection, or a first-degree relative with a history of meningococcal infection
- •4. Have a history of seizures or any disorder of the brain
- •5. Participants with a female partner who is pregnant, nursing, or planning to become pregnant during the confinement phase of the study or within 90 days of study drug administration
- •6. Sensitivity to any of the study interventions, or components thereof, or drug or other allergy (including a history of hypersensitivity reactions to ciprofloxacin or other antibiotics, including beta-lactams, penicillin, aminopenicillins, other fluoroquinolones, cephalosporins, and/or carbapenems) that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.
- •7. Use of prohibited over-the-counter or prescription medications as follows (other than ciprofloxacin, administered as part of this study for nasopharyngeal decolonization 7 to 10 days before dosing):
- •Prescription medications (systemic and topical) within 14 days prior to first study drug administration (or when known, 5 half-lives, whichever is longer) through study completion, including follow-up visits.
- •Non-prescription medications (including lipid-soluble vitamins A, D, E, and K [water-soluble vitamins B and C are not prohibited], herbal supplements, and dietary supplements) within 14 days of first study drug administration.
- •Medications known to induce or inhibit hepatic microsomal enzyme cytochrome P450 (CYP450) activity (e.g., quinines) within 28 days of first study drug administration
- •Hormonal therapy/replacement medications within 28 days of first study drug administration.
- •8. Live attenuated vaccine within 30 days or other vaccine within 14 days of first study drug administration.
- •9. Donated blood or lost more than 500 mL of blood within 3 months prior to first study drug administration, or received a blood transfusion or blood products within 6 months prior to first study drug administration.
- •10. Current enrolment or past participation within the last 30 days before study drug administration in any clinical study involving an investigational study intervention or any other type of medical research.
- •11. Test positive for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV) at screening.
- •12. Positive serum hCG (female participants only).
- •13. Have clinically significant laboratory abnormalities, including any of the following, at either screening or Day -1:
- •Serum creatinine >ULN and/or creatinine clearance <80 mL/minute estimated by the Cockcroft-Gault formula [(140 - age) × weight (kg) / 72 × serum creatinine (mg/dL)]
- •Alanine transaminase > ULN
- •Aspartate transaminase > ULN
- •Alkaline phosphatase > ULN
- •Total bilirubin > ULN
- •Absolute neutrophil count (ANC) < lower limit of normal (LLN)
- •Abnormal coagulation profile, including platelet
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