Study To Assess Safety, Tolerability And PK Of ATB-346 In Healthy Subjects
CompletedPhase 1NCT03220633
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
Brief summary (from the registry)
A double-blind, placebo-controlled, phase I study to assess safety, tolerability and pharmacokinetics of single/multiple ascending doses of atb-346 orally administered in healthy male and female subjects.
Study details
- Official title
- A Double-Blind, Placebo-Controlled, Phase I Study To Assess Safety, Tolerability And Pharmacokinetics Of Single/Multiple Ascending Doses Of ATB-346 Orally Administrated In Healthy Male And Female Subjects
- Conditions
- Interventions
- Drug: ATB-346
- Drug: Placebo
- Sponsor
- Antibe Therapeutics Inc.
- Collaborators
- Algorithme Pharma Inc
- Start date
- 2014-06
- Primary completion
- 2014-12
- Sex
- All
- Age range
- from 18 Years to 55 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- Canada
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Availability for the entire study period 2. Motivated volunteer and absence of intellectual problems likely to limit the validity of consent to participate in the study or the compliance with protocol requirements; ability to cooperate adequately; ability to understand and observe the instructions of the physician or designee 3. Healthy male or female subjects aged between 18 and 55 years, inclusive, at the time of informed consent 4. Body mass index (BMI) greater than or equal to 18.50 kg/m2 and below 30.00 kg/m2 5. Non- or ex-smokers. An ex-smoker is defined as someone who completely stopped smoking for at least six months before Day 1 of this study 6. Clinical laboratory values within the laboratory's stated normal range; if not within this range, these must be without any clinical significance 7. Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination and/or clinical laboratory evaluations (hematology, general biochemistry, electrocardiogram \[ECG\], and urinalysis) 8. Willingness to adhere to the protocol requirements as evidenced by the informed consent form (ICF) duly read, signed and dated by the volunteer 9. A female volunteer must meet one of the following criteria: * If of childbearing potential - agrees to use one of the accepted contraceptive regimens from at least 28 days prior to the first drug administration, during the study and for at least 60 days after the last dose. An acceptable method of contraception includes one of the following: * Abstinence from heterosexual intercourse * Systemic contraceptives (birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch) * Intrauterine device (with or without hormones) * Condom with spermicide * If of non-childbearing potential - should be surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or in a menopausal state (at least one year without menses) 10. A male volunteer with sexual partners who are pregnant, possibly pregnant, or who could become pregnant must meet the following criterion: * Participant is inapt to procreate, defined as surgically sterile (i.e. has undergone a vasectomy, it must be at least 6 months since the surgery) * Participant agrees to use of the accepted contraceptive regimens from first drug administration until 3 months after the last drug administration. An acceptabl…
Canadian sites (1)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03220633