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AC0058TA

Phase 1

Healthy Volunteers | Small molecule | Other |Scilex Holding Company|Last Updated: Feb 28, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment56

FDA Designations

No designations recorded

Clinical trial landscape

AC0058TA · 1 trial · 1 indication

Phase 1 1
NCT02847325Study of AC0058TA in Healthy Male and Female SubjectsHealthy Volunteers
COMPLETED56 Analytics
PHASE1COMPLETED
Study of AC0058TA in Healthy Male and Female Subjects
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Study Endpoints

Primary Endpoints

Safety and tolerability of single and multiple oral doses of AC0058TA determined by adverse events
within 6 days after single dose in part 1, within 14 days after last dose in part 2.

Frequency and severity of AEs and serious AEs

Secondary Endpoints

Plasma concentrations of single dose or multiple doses of AC0058TA
within 6 days after single dose in part 1, within 14 days after last dose in part 2.
Time to maximum observed concentration (Tmax)
within 6 days after single dose in part 1, within 14 days after last dose in part 2.
Area under the concentration-time curve (AUC)
within 6 days after single dose in part 1, within 14 days after last dose in part 2.
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AC0058TAEXPERIMENTALDrug: 50 mg AC0058TA Drug: 100 mg AC0058TA Drug: 200 mg AC0058TA Drug: 400 mg AC0058TA
Placebo capsulesPLACEBO_COMPARATORDrug: Placebo capsules

Interventions

NameTypeDescription
AC0058TADRUG50 mg AC0058TA 100 mg AC0058TA 200 mg AC0058TA 400 mg AC0058TA
Placebo capsulesDRUGPlacebo capsules
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male or female, of any ethnic origin, age ≥18 and ≤65 years of age; * BMI ≥18.5 and ≤32.0 kg/m2; * Medical history without major pathology and determined to be in good health with no clinically significant findings as assessed by the Investigator; * All clinical laboratory tes...

Countries:United States
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Frequently asked questions about AC0058TA

What is AC0058TA used for?

AC0058TA is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, meaning it has not been approved for any medical use. The drug is being evaluated for safety and tolerability in a clinical trial setting.

Who makes AC0058TA?

AC0058TA is being developed by Scilex Holding Company, a biopharmaceutical company. Scilex is publicly traded under the ticker symbol SCLX. The company is conducting clinical research on this investigational drug candidate.

What phase is AC0058TA in?

AC0058TA is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains in early-stage clinical research.

What clinical trials is AC0058TA in?

AC0058TA has one completed clinical trial, identified as NCT02847325. This Phase 1 study, titled "Study of AC0058TA in Healthy Male and Female Subjects," was conducted in the United States and enrolled 56 participants. The trial was randomized, double-blind, and placebo-controlled.

Is AC0058TA the same as any other drug?

AC0058TA is the primary name for this investigational drug candidate. No alternative names have been reported for this compound in the available clinical trial information. It is being studied under this name in its Phase 1 clinical development.