Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000642583
Ethics application status
Approved
Date submitted
16/04/2024
Date registered
20/05/2024
Date last updated
20/05/2024
Date data sharing statement initially provided
20/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of STC-004
Scientific title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of STC-004 in Healthy Adults
Secondary ID [1] 311817 0
STC-004-CS-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute, post-operative pain 333345 0
Chronic, peripheral neuropathic pain 333346 0
Condition category
Condition code
Anaesthesiology 330026 330026 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will be conducted in 2 parts:
Part A: Single ascending doses of STC-004 or placebo. Upto 5 cohorts are planned starting at 5mg and going up to maximum dose of 100mg. Participants will be administered the study drug in fasted state as an oral suspension solution followed by 250 mL of water. Study drug will be administered to the participants by the site staff while confined at the clinical site.
Part B: Multiple ascending doses of STC-004 or placebo for 10 days. Upto 3 cohorts are planned and will commence once results are available from the first 3 SAD cohorts. Dose selection and initiation of additional MAD cohorts will be based on cumulative results from the completed SAD and MAD cohorts. Participants will be administered the study drug once daily for a period of 10 days in fasted state as an oral suspension solution followed by 250 mL of water. Study drug will be administered to the participants by the site staff while confined at the clinical site.
Intervention code [1] 328267 0
Treatment: Drugs
Comparator / control treatment
Placebo-to-match. Placebo will be composed of glucose as the inactive ingredient and will be prepared to match in appearance and taste to STC-004 oral suspension.
Control group
Placebo

Outcomes
Primary outcome [1] 337782 0
To evaluate the safety and tolerability of STC-004 in healthy participants following single ascending doses in healthy participants.
Timepoint [1] 337782 0
Part A: Outcomes will be assessed daily at Baseline (Day -1), Day 2, Day 3, Day 4, Day 5 and Follow-up (Day 8-10).
Primary outcome [2] 338172 0
To evaluate the safety and tolerability of STC-004 in healthy participants following multiple ascending doses in healthy participants.
Timepoint [2] 338172 0
Part B: Outcomes will be assessed daily at Baseline (Day -2), Day -1, daily during Days 1 to 14 and Follow-up (Day 19-21).
Secondary outcome [1] 433319 0
To characterize the pharmacokinetics (PK) of STC-004 following a single dose in healthy participants
Timepoint [1] 433319 0
Blood samples will be collected and measured on Day 1 pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, and 96 hours post-dose.
Secondary outcome [2] 434029 0
To characterize the pharmacokinetics (PK) of STC-004 following multiple doses in healthy participants
Timepoint [2] 434029 0
Blood samples will be collected and measured on Day 1, pre-dose and 0.5, 1, 2,
4, 8, 12, and 24 hours post-dose, on Days 3, 5, 7 and 9 pre-dose, and Day 10 pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours post dose.
Urine samples will be collected measured on Day 10 pre-dose and 0-6 hours, 6-12 hours, and 12-24 hours post dose.

Eligibility
Key inclusion criteria
- Healthy male and/or female, 18 to 55 years of age, inclusive with BMI between 18.0 to 32.0 kg/m2, inclusive
- Medically healthy without clinically significant abnormalities based on physical examination, vital signs, ECG, and clinical laboratory tests
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, or neurological disease, including any acute illness or surgery within the past 3 months determined by an Investigator to be clinically relevant.
- History of drug or alcohol abuse
- Use of an prescription medications or over-the-counter medications (excluding contraceptives), including herbal products and vitamins within 14 days or 5 half-lives (whichever is longer)
- Blood donation of approximately 500 mL within 56 prior to Screening
- Any condition or prior therapy, eg. seizures or head trauma, that may lead to CNS effects during the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomized to receive STC-004 or Placebo according to the randomisation schedule and plan prepared prior to study start. Code-break tamper-evident envelopes containing treatment allocation per participant will be provided to the study site for emergency unblinding if required.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants who meet the study eligibility criteria will be assigned a randomisation number pre-dose on Day 1, which corresponds to a study treatment (STC-004 or placebo). The allocation of STC-004 or placebo will be performed using a block randomization algorithm
and will be documented in the study randomization list generated by an unblinded statistician.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/06/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
76
Accrual to date
Final
Recruitment outside Australia
Country [1] 26219 0
New Zealand
State/province [1] 26219 0

Funding & Sponsors
Funding source category [1] 316153 0
Commercial sector/Industry
Name [1] 316153 0
SiteOne Therapeutics
Country [1] 316153 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
SiteOne Therapeutics
Address
Country
United States of America
Secondary sponsor category [1] 318332 0
Commercial sector/Industry
Name [1] 318332 0
Avance Clinical Pty Ltd
Address [1] 318332 0
Country [1] 318332 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314982 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 314982 0
https://ethics.health.govt.nz/about/central-health-and-disability-ethics-committee/
Ethics committee country [1] 314982 0
New Zealand
Date submitted for ethics approval [1] 314982 0
07/04/2024
Approval date [1] 314982 0
06/05/2024
Ethics approval number [1] 314982 0

Summary
Brief summary
This is a double-blind, randomized, placebo-controlled study which is subdivided in 2 parts, Part A (SAD - Cohorts 1-5) and Part B (MAD - Cohorts 6-8). Decisions about how and when to move between cohorts will be based on reviews of the available blinded safety data and available pharmacokinetic (PK) data: this data will be reviewed by a prespecified Safety Review Committee (SRC). In Part A, healthy volunteers will be enrolled to receive single ascending doses of STC-004 or placebo under fasted conditions. In Part B, healthy volunteers will be enrolled to receive once daily doses of STC-004 or placebo under fasted conditions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133314 0
Dr Chris Wynne
Address 133314 0
New Zealand Clinical Research, 3 Ferncroft Street, Grafton, Auckland 1010, New Zealand
Country 133314 0
New Zealand
Phone 133314 0
+64 272443963
Fax 133314 0
Email 133314 0
Chris.Wynne@nzcr.co.nz
Contact person for public queries
Name 133315 0
Chris Wynne
Address 133315 0
New Zealand Clinical Research, 3 Ferncroft Street, Grafton, Auckland 1010, New Zealand
Country 133315 0
New Zealand
Phone 133315 0
+64 272443963
Fax 133315 0
Email 133315 0
Chris.Wynne@nzcr.co.nz
Contact person for scientific queries
Name 133316 0
Chris Wynne
Address 133316 0
New Zealand Clinical Research, 3 Ferncroft Street, Grafton, Auckland 1010, New Zealand
Country 133316 0
New Zealand
Phone 133316 0
+64 272443963
Fax 133316 0
Email 133316 0
Chris.Wynne@nzcr.co.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.