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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12624000642583

Enrollment

Registered

2024-05-20

Start date

2024-06-11

Completion date

2024-10-12

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

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

Outcome results