To Assess the Safety, Tolerability and Pharmacokinetics of ACH-000029 in Healthy Subjects

Syneos Health

Status and phase: Terminated; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: ACH-000029; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05363839

X07-201-00001

Details and patient eligibility

About

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

Full description

This study will be conducted in up to 3 dosing groups of 8 total subjects each.

The purpose of this trial is to determine the safety and tolerability of a single dose of ACH-000029 or placebo.

Enrollment: 8 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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8 participants in 2 patient groups, including a placebo group

SAD Cohorts 1 to 3 - Participants Receiving ACH-000029

Experimental group

Description:

Each SAD cohort participant will be randomized to receive 10mg for cohort 1; up to 30mg and up to 60mg for cohorts 2 and 3 respectively dependent on dose review committee.

Treatment:

Drug: ACH-000029

SAD Cohorts 1 to 3 - Participants Receiving Placebo

Placebo Comparator group

Description:

Each SAD cohort participant will be randomized to receive placebo on a ratio of 3:1 (active: placebo).

Treatment:

Drug: Placebo