A Single-Arm, Single Sequence, Multiple Ascending Dose Study of the Safety and Tolerability of AB-2004 in a Pediatric Autism Spectrum Disorder Population

Axial Biotherapeutics Australia Pty Ltd.0 个研究点目标入组 35 人开始时间: 2018年12月4日最近更新: 2019年12月10日

试验速览

暂无简介。

•Participants must meet all inclusion criteria's (and not meet exclusion criteria) to be enrolled in the study. Following are the key Inclusion Criteria -
•Inclusion Criteria:
•1. Clinically diagnosed, documented Autism Spectrum Disorder (DSM-V criteria)
•confirmed with ADOS-2 at Visit 1 or within 18 months prior to Visit 1.
•2. Adolescents greater than or equal to 12 and less than 18 years of age at the time of consent
•3. History of gastrointestinal symptoms (diarrhea, constipation, abdominal pain,
•bloating) confirmed in the e-diary with at least 50% compliance of entry for at least
•14 days during the screening period.
•4. Male subjects who are post-pubertal must be sterile (surgically or otherwise) for at
•least 6 months or are using single barrier contraception during the duration of the
•trial and up until 1 month after the last dose AB-2004.
•Female subjects that are not lactating and have a negative pregnancy test at the
•Screening and who are surgically sterile for at least 6 months or who agree to use
•double-barrier contraception, an intrauterine device, or an oral contraceptive over the
•duration of the trial and at least 4 weeks after the last dose of AB-2004

•Participants must not meet any exclusion criteria (and meet all inclusion criteria) to be enrolled in the study. Following are the key Exclusion Criteria -
•1. History of inflammatory bowel disease, bowel obstruction, diverticulosis or colon
•2. Oral, injected, inhaled antibiotic within 30 days prior to Screening
•3. Currently taking a controlled or extended-release medication
•4. History of significant gastric or intestinal surgery (excluding appendectomy).

发起方

Axial Biotherapeutics Australia Pty Ltd.