Recent Updates
Recently added Catalysts

AC0058TA

Phase 1

Undisclosed | Small molecule | Other |Scilex Holding Company|Trials Updated: Feb 28, 2019

AC0058TA development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Jul 2016

AC0058TA target and mechanism

ModalitySmall molecule

Also known as AC0058

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment56

FDA Designations

No designations recorded

AC0058TA clinical trials

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
Healthy VolunteersUnlock trial analytics

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.
Unlock Study Endpoints

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
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about AC0058TA

What is AC0058TA?

AC0058TA is an investigational small molecule drug being developed by Scilex Holding Company. It has been studied in a Phase 1 clinical trial in healthy adult volunteers in the United States. The specific therapeutic indication for AC0058TA has not been publicly disclosed.

Who is developing AC0058TA?

AC0058TA is being developed by Scilex Holding Company, which trades under the ticker symbol SCLX. Scilex is the sponsor of the clinical program evaluating this small molecule asset.

What phase is AC0058TA in?

AC0058TA is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA.

What clinical trials has AC0058TA been studied in?

AC0058TA has been evaluated in one clinical trial, NCT02847325, titled Study of AC0058TA in Healthy Male and Female Subjects. The Phase 1 trial enrolled 56 healthy volunteers in the United States, was randomized, double-blind, and placebo-controlled, and has been completed.

What was the design of the AC0058TA Phase 1 trial?

The Phase 1 trial of AC0058TA, NCT02847325, was a randomized, double-blind, placebo-controlled study conducted in the United States. It enrolled 56 healthy male and female volunteers aged 18 years and older. The trial has been completed.