Study to Assess the Safety, Tolerability, Pharmacokinetic of Thrv-1268 (NCT06507839) | Clinical Trial Compass
CompletedPhase 1
Study to Assess the Safety, Tolerability, Pharmacokinetic of Thrv-1268
Canada56 participantsStarted 2024-05-15
Plain-language summary
This is a single-center, randomized, double-blind, placebo-controlled study to be conducted in 2 parts: single ascending dose (SAD) incorporating a food effect arm and multiple ascending dose (MAD). Potential participants for each part will undergo screening procedures within 28 days of enrollment.
Who can participate
Age range18 Years – 60 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓.Provision of signed and dated Informed Consent Form (ICF). 2.Stated willingness to comply with all study procedures and availability for the duration of the study.
✓.Healthy adult male or female subjects. 4.If female, meets one of the following criteria:
✓. Abstinence from heterosexual intercourse from Screening through at least 30 days from last study dose.
✓. One of the following highly-effective contraception methods:
✓. systemic contraceptives (combined birth control pills, injectable/implant/ insertable hormonal birth control products, or transdermal patch) used from at least 28 days prior to Screening through to at least 30 days from last study dose
✓. intrauterine device (with or without hormones) used from at least 28 days prior to Screening through to at least 30 days from last study dose
✓. male partner vasectomized at least 6 months prior to Screening visit
✓. One of the following double-barrier contraception methods used from Screening through at least 30 days from last study dose
Exclusion criteria
✕. Clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease, or any other condition, which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
✕. Clinically significant abnormal findings on the physical examination or medical history during Screening as deemed by the Investigator.
What they're measuring
1
Safety and Tolerability: Number of Participants with Adverse Events
Timeframe: SAD: Day 7; Food Effect: Day 15; MAD: Day 16
✕. Female who is pregnant according to the pregnancy test at Screening or prior to the first study drug administration.
✕. Male subjects with a history of oligospermia or azoospermia or any other disorder of the reproductive system.
✕. Male subjects who are undergoing treatment or evaluation for infertility.
✕. The average of 3 measurements performed approximately 5 min apart: Screening or baseline (Day -1) diastolic BP \<50 mmHg or \>95; systolic BP \<100 mmHg or \>145 mmHg; or HR ≤ 50 beats per minute (bpm) using a validated digital BP device. These can be repeated in triplicate once after an additional quiet resting period.
✕. Orthostatic BP performed after sitting quietly for at least 4 minutes and then standing for 2 minutes with a duplicate set performed after at least 3 minutes of sitting, with a reduction in systolic BP \>20 mmHg, a reduction in diastolic BP \>10 mmHg, or an increase in HR \>20 bpm using a validated digital BP device.