A Phase 1, Single-Ascending-Dose Study of BT051 in Healthy Subjects

Healthy Volunteers Clinical Trial

Official title: A Phase 1, Randomized, Double-Blind, Single-Ascending-Dose Study Evaluating the Safety, Tolerability, and Pharmacokinetics of BT051 in Healthy Subjects

Status Completed

Clinical Trial Summary

This is a randomized, double-blind, placebo-controlled study to assess the safety and tolerability of single ascending doses of BT051 in healthy male or female volunteers aged 18 to <50 years. A total of 50 subjects will be randomized to receive a single oral dose of BT051 or matching placebo in a ratio of 4 active:1 placebo in 5 ascending dose cohorts (10 subjects per cohort) at active dose levels of 100mg, 300mg, 700mg, 1500mg or 3500mg. The study Safety Review Committee (SRC) will evaluate if any dose-limiting adverse events (AEs) occurred in a cohort through Day 3, as well as review cumulative safety data for all previous cohorts and any available pharmacokinetic (PK) data before proceeding to dosing in the next cohort.

Clinical Trial Description

BT051-1-001 is a phase 1, randomized, double-blind, single center, single-ascending-dose study in which healthy subjects will receive a single oral dose of BT051 or placebo while confined to the clinical unit. Approximately 50 subjects will be enrolled in 5 sequential, ascending dose cohorts.

Healthy male and female adult subjects will be enrolled and screened for participation within 28 days before the scheduled administration of study drug. After written informed consent is obtained, the screening procedures will include: medical history, documentation of prior medications (i.e., medications taken within 30 days before the scheduled dose of study drug), viral serology tests, clinical laboratory testing, pregnancy testing (for women of childbearing potential), 12 lead electrocardiograms (ECGs), vital sign measurements, and physical examination.

After confirmation of inclusion and exclusion criteria, subjects eligible for randomization will be admitted to the clinical unit 1 day before the scheduled administration of study drug (Day -1) and will be confined in the clinical unit until the morning of Day 3. All subjects will return to the clinical unit on Day 7 (-1 or +2 days) and for the last follow-up on Day 30 (±3 days) for study assessments.

A total of 10 subjects will be randomized to receive BT051 or placebo (8 active:2 placebo) in each of the following sequential dose escalating cohorts: 100mg, 300mg, 700mg. 1500mg and 3500mg. Administration of a single dose of study medication on Day 1 will occur under fasted conditions (i.e., no food allowed overnight before dosing until at least 4 hours after dosing). Except for approximately 240-480 mL of water given with study drug, no fluid will be allowed from 1 hour before dosing until 1 hour postdose; water will be provided ad libitum at all other times.

The study Safety Review Committee (SRC) will evaluate if any dose-limiting adverse events (AEs) through Day 3 occurred in a cohort before proceeding to dosing in the next cohort. In addition, cumulative safety data will be reviewed for all previous cohorts along with any available pharmacokinetic (PK) data. A lower dose may be explored in case dose-limiting AEs are observed at a higher dose level.

For PK analyses, blood, urine, and fecal samples will be collected from each subject. Blood samples will be collected on Day 1 at predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, and 48 hours postdose. Urine samples will be collected at the following intervals (pooled for each collection interval): 0-4, 4-8, 8-24, and 24-48 hours postdose. One stool sample will be collected prior to dose (from Days -2 to Day 1). Following dosing on Day 1, all stool samples will be collected through Day 3 (48 hours postdose) while the subject is confined to the clinical unit. In addition, a stool sample will be collected on Day 7 (-1 or +2 days).

Safety assessments will include monitoring of AEs, clinical laboratory testing, vital sign measurements, physical examinations, and ECGs at select time points for 30 days following the dose of study drug. Potential systemic pharmacologic T-cell immunosuppressive activity will be evaluated. ;

Related Conditions & MeSH terms

• Healthy Volunteers

• NCT number: NCT05103878
• Study type: Interventional
• Source: Adiso Therapeutics
• Status: Completed
• Phase: Phase 1
• Start date: June 24, 2020
• Completion date: November 13, 2020