A Randomised, Double-Blind, Placebo-Controlled, Single- and Multiple-, Ascending-Dose Study of the Safety, Tolerability, and Pharmacokinetics and Pharmacodynamics of VRG50635 and Food Effect in Healthy Volunteers (Phase 1a)

Recruiting

Conditions: Amyotrophic lateral sclerosis
10041543

Registration Number: NL-OMON56052

Lead Sponsor: Verge Genomics

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 84

Inclusion Criteria

Inclusion criteria - Parts 1 and 2
1. Healthy male or female between 18 to 65 years of age at screening
(inclusive).
4. For male and female subjects of childbearing potential: Subjects and their
spouse/partners who are of childbearing potential must use highly effective
contraception when engaging in sexual activity consisting of 2 forms of birth
control (1 of which must be a barrier method such as latex or polyurethane
condoms) starting at screening and continue throughout the clinical study
period, and for 90 days after the final study drug administration.
5. For males: Subject must not donate sperm starting at screening and
throughout the clinical study period, and for 90 days after the final study
drug administration.

Exclusion Criteria

Exclusion criteria - Parts 1 and 2
1. History of clinically significant hematological, renal, neurologic,
pancreatic, gastrointestinal, hepatic, cardiovascular, psychological,
pulmonary, metabolic, endocrine, immunological, allergic disease, or other
major disorders.
2. Current significant medical or psychiatric condition.
4. Evidence of clinically significant hepatic or renal impairment in the
opinion of the investigator, including alanine aminotransferase (ALT) or
aspartate aminotransferase (AST) >1.5 the upper limit of normal (ULN) or
bilirubin > 1.5 ULN. Patients with Gilbert syndrome without evidence of hepatic
impairment may be enrolled.
14. Poor peripheral venous access.
21. A lifetime history of suicidal behavior or suicidal ideation as determined
by a positive response (**Yes**) to either question 4 or question 5 of the
C-SSRS at screening.
26. For part 2 only: Subjects not eligible for lumbar puncture
(anti-coagulation, anti-aggregation or blood coagulation pathologies, recent
spine surgery, acquired or congenital spine malformation, clinical signs of
intracranial hypertension, cutaneous infection at the punction site)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Part 1; Single ascending dose:<br /><br>• Assessment of adverse events (AEs), vital signs, electrocardiograms (ECGs),<br /><br>physical examinations, Columbia Suicide Severity Rating Scale (C-SSRS) and<br /><br>laboratory safety tests<br /><br><br /><br>Part 2; Multiple ascending dose<br /><br>• Assessment of AEs, vital signs, ECGs, physical examinations, C-SSRS and<br /><br>laboratory safety tests</p><br>

Secondary Outcome Measures