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COMPLETEDPHASE1

Ascending Single-Dose Study to Evaluate VIA-3196 in Healthy Subjects

A Randomized, Double-blind, Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of VIA-3196 in Healthy Subjects

NCT01367873•Madrigal Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

This is a single-center, randomized, double-blind, placebo-controlled, ascending single-dose study of VIA-3196 to evaluate the Safety, Pharmacokinetics and Pharmacodynamics of VIA-3196 in Healthy Subjects. Study dosing is organized into cohorts corresponding to escalating doses of VIA-3196 or matching placebo.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•The subject must be willing and able to provide written informed consent.
•Healthy, non-smoking, males and females between the ages of 18 and 55 years of age (inclusive).
•If female, the subject is of non-child bearing potential (i.e., surgically \[bilateral oophorectomy, hysterectomy, or tubal ligation\] or naturally sterile \[\>12 consecutive months without menses\]). Verify by FSH at screening as appropriate.
•Body weight \> 50 kg and BMI between 18 and 30 kg/m2 (inclusive).
•LDL cholesterol \> 85 mg/dL.
•No clinically significant abnormal findings on blood pressure, heart rate, physical examination, clinical laboratory tests or 12-lead ECG.

Exclusion Criteria

•History of thyroid disorder or abnormal thyroid function tests at screening. Repeat testing is allowed at the discretion of the Investigator.
•History of unexplained syncope.
•History of hepatobiliary disease; or AST, ALT or direct bilirubin greater than the upper limit of reference range at screening.
•Positive screening test for HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody.
•Abnormal screening ECG: including machine-read QTc \>450 msec, QRS \>110 msec, intermittent bundle branch block, frequent premature atrial or premature ventricular contractions, or any rhythm other than normal sinus rhythm which is interpreted by the Investigator to be clinically significant.
•History of sensitivity to a similar study drug (e.g., Karo Bio KB2115 or Metabasis MB7811), or a history of important drug or other allergy (except for untreated, asymptomatic seasonal allergies at time of dosing).
•Sensitivity to thyroid medication.
•History of asthma, or intolerance to beta-blockers.
•Use of acetaminophen within 7 days before dosing and throughout the study.
•History of regular use of tobacco or nicotine containing products within the past 6 months.
+1 more criteria

Locations (1)

Cetero Research

Fargo, North Dakota, United States

Key Dates

Start Date

June 1, 2011

Primary Completion Date

October 1, 2011

Completion Date

October 1, 2011

Last Updated

August 22, 2023

Enrollment

ACTUAL participants

Conditions

Drug Safety

Interventions

Placebo

DRUG

VIA-3196

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 22, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Ascending Single-Dose Study to Evaluate VIA-3196 in Healthy Subjects

Inclusion Criteria

Exclusion Criteria

Reducing and Removing Hyaluronic Acid Filler With Hyaluronidase

Use of Intranasal Midazolam to Reduce Stress and Procedural Pain in Premature Infants During Routine ROP Examination.

Comparison of PSORI-CM01 Formula vs Gu Ben Hua Yu Formula Combined With AD-MSCs in Psoriasis

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An Assessment of the Safety and Pharmacokinetics of Ascending Doses of SANGUINATE™ in Healthy Volunteers.