A Phase 1, Single-center, Placebo-controlled, Double-blind, Randomized Trial to Assess the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of ACH-000029 in Healthy Subjects

X07-201-00001

Randomized single ascending dose placebo controlled treatment of ACH-000029 administered orally via capsule in healthy volunteers.

2022-05-06

2022-11-02

2022-11-02

Terminated

Early phase I

8

Inclusion Criteria: * Healthy male or non-childbearing potential female. * Surgically sterile male and female. Exclusion Criteria: * Breastfeeding female subjects. * Clinical abnormal past medical history. * History of drug and/or alcohol abuse within 2 years prior to screening. * History of or current hepatitis or acquired immunodeficiency syndrome or carriers of hepatitis B surface antigen and/or anti-hepatitis C virus antibodies, or human immunodeficiency virus (HIV) antibodies. * History of any significant drug allergy or known or suspected hypersensitivity. * A positive urine or breath alcohol test and/or urine drug screen for substances of abuse at screening or upon admission to the trial site (Day -1). * Subjects having taken an investigational drug within 30 days prior to screening or a biological investigational product within 30 days or 5 half-lives (whichever is longer) preceding screening, except the last dose of severe acute respiratory syndrome coronavirus (SARS-CoV-2 \[COVID-19\]) vaccine, which must be administered at least 7 days prior to screening. * Any history of significant bleeding or hemorrhagic tendencies. * Any history of difficulty in donating blood. * The donation of blood or plasma within 30 days prior to the first dose of IMP. * Use of prescription, over-the-counter, or herbal medications or vitamin supplements within 14 days prior to the first dose of IMP and oral antibiotics within 30 days prior to the first dose of IMP. * Use of tobacco products or daily exposure to second-hand smoke within 2 months prior to the screening visit. * Presenting with, or having a history of, uncontrolled hypertension (SBP \> 140 mmHg or DBP \> 90 mmHg) or symptomatic hypotension, or orthostatic hypotension, which is defined as a decrease of ≥ 30 mmHg in SBP or a decrease of ≥ 20 mmHg in DBP after at least 3 minutes of standing compared with the previous supine BP, OR development of symptoms. * Supine HR, after resting for at least 3 minutes, outside the range of 50 to 90 bpm. * Abnormal ECG findings at screening or check-in. * History of unexplained syncope, where orthostatic likely event. * Personal or family history of sudden death or long QT syndrome. * History of serious mental disorders that, in the opinion of the investigator, would exclude the subject from participating in this trial. * No permanent place of residence. * Subjects with active suicidal ideation prior to dosing.

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2023-04-27