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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000756325
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
5/06/2026
Date registered
Help: Date registered
25/06/2026
Date last updated
Help: Date last updated
28/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
25/06/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
SCY-770 Multiple Ascending Dose Study in Healthy Participants (Cohorts 2–3)
Scientific title
A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate The Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Oral SCY-770 in Healthy Participants for cohort 2 & 3
Additional trial identifiers [1] 317491 0
SCY-770-101
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Non-Alcoholic Fatty Liver Disease [NAFLD] 342203 0
Condition category
Condition code
Metabolic and Endocrine 338349 338349 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
SCY770 will be provided as tablets for oral administration with 240ml of room temperature water and the same will be matched for Placebo

This study includes three parts (cohorts) and is conducted in healthy participants. Subjects will not be repeated for any of the cohorts

Cohorts 2 and 3 are double-blind, randomized, placebo-controlled studies to evaluate the safety, tolerability, and pharmacokinetics of repeated doses of SCY-770. Each cohort will include 8 participants (3:1ratio of SCY-770 to placebo).

In Cohort 2, participants will receive 750 mg once daily for 7 days.

In Cohort 3, participants will receive 500 mg twice daily for 6 days, followed by 500 mg once on Day 7.Dosing will begin with 2 participants (1 active, 1 placebo), and if safe, the remaining participants will be dosed after at least 2 days.

Safety data from Cohort 2 will be reviewed before starting Cohort 3.
Intervention code [1] 334292 0
Treatment: Drugs
Description of the comparator or control
Placebo is a immediate release film-coated tablet which is identical to the IP in composition except the active ingredient.
(Composition: Lactose monohydrate, Microcrystalline cellulose, Povidone, Sodium lauryl sulphate, Crospovidone, Silicon dioxide, Magnesium stearate, Opadry® TF 268U220002 Yellow)
Control group
Placebo

Outcomes
Primary outcome [1] 345668 0
Safety and tolerability will be assessed as a Composite outcome and evaluated through monitoring of adverse events (AEs), vital signs, serial ECGs, and clinical laboratory assessments (blood and urine), along with physical examinations
Timepoint [1] 345668 0
Cohort 2& Cohort3 - 12Lead ECG: Screening, Day-1/-2, Day1, Day2, Day3, Day4, Day 5, Day 6, Day 7, Day 8, Day 9 , Post Study. -Holter ECG recordings will be obtained from approximately 24.5 hours prior to morning dosing on Day 1 until 24 hours post dose, and from 0.5 hours prior to morning dosing on Day 7 until 24 hours post dose. Extraction timepoints will include pre-dose and 0.5, 1, 2, 2.5, 3, 4, 6, 12, 16, and 24 hours post dose on Day 1 and Day 7, with Day -1 corresponding to the Day 1 baseline timepoints. - Vital signs: at screening; Day -2; Days 1 and 7 before morning dose and then at 1, 2, 4, 8, 12, 16 (Cohort 3 only) hours post dose; Days2-6 pre dose and 4 hours post dose; Days 8-13 prior to PK blood samples; Post study visit. - Laboratorysafety tests: coagulation (screening only); hematology, clinical chemistry, urinalysis on Screening, Day -1,Day2, Day4, Day7, Day9, Day13, Day25/End of Treatment. -Physical Examination: Screening, Day -1/-2, Day 2, Day 5, Day 9, Post Study. -Adverse Event: Adverse events and concomitant medication will be collected from the time of informed consent, Screening, Day-1. pre dose, Day 1, day2, day3, day4, day5, day6, day7, day7, day8, day9, day10, day11, day12, day13, day25 through the Post study visit/End of treatment.
Secondary outcome [1] 462795 0
Pharmacokinetics will be evaluated using the following parameters: maximum plasma concentration(Cmax), time to reach Maximum plasma concentration (Cmax) (Time to maximum concentration - Tmax), elimination rate constant, elimination half-life (T½), area under the concentration–time curve from time zero to 12 hours post-dose (AUC0–12), from time zero to 24 hours post-dose (AUC0–24), from timezero to the last measurable concentration (AUC0–t), and from time zero extrapolated to infinity (AUC0–8).
Timepoint [1] 462795 0
Cohort 2 & Cohort 3 - Blood PK sampling (Cohort 2): Day1 predose and at 1, 2, 3, 4, 6, 8, 12 and 14 hours post dose; Days 2, 3, 4 predose; Days 5 and 6: predose and at 2 hours postdose; Day 7 predose and at 1, 2, 3, 4, 6, 8, 12, 14, 24, 36, 48, 72, 96, 120 and 144 hours postdose. -Blood PK sampling (Cohort 3): Day 1 before AM dose and at 1, 2, 3, 4, 6, 8, 12 and 14 hours after AM dose; Days 2, 3, 4 predose (AM and PM); Days 5 and 6: before AM dose and at 2 hours after AM dose and beforePM dose; Day 7 pre dose and at 1, 2, 3, 4, 6, 8, 12, 14, 24, 36, 48, 72, 96, 120 and 144 hours postdose.

Eligibility
Key inclusion criteria
- The participant should be a healthy man or woman between 18 and 50 years old.
- Their body weight and body mass index (BMI) should be within a healthy range.
- The participant should be in good overall health, based on medical history, physical check-up, hearttracing (ECG), vital signs, and lab test results.
- The participant should not be a smoker and should not have used nicotine products for at least 6 months.In some cases, very occasional smoking (up to 2 cigarettes per week in the last 3 months) may still beallowed if the doctor agrees.
- The participant must clearly understand the study and agree to take part by signing a consent form.
- The participant must be willing to follow all study rules and stay in the study until it is completed.
- The participant should not have any special diet restrictions that would interfere with fasting or eatingstandardized meals provided during the study.
- Women should not be pregnant or breastfeeding.
- Women who can become pregnant must use highly effective birth control during the study and for 28days after it ends, and must have negative pregnancy tests before and during the study.
- Men must either be surgically sterile or use effective contraception if their partner can become pregnant.They must also not donate sperm during the study and for 90 days after the last dose.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
- If a person has any mental health condition that may make it difficult for them to follow the study rules orcomplete the study, they will not be included.
- If a person has any past illness or medical condition that could affect the study results or makeparticipation unsafe, they will not be included.
- People who have had a fever (above 38degree Celsius) or any infection in the past 2 weeks will not beincluded.
- People who have difficulty swallowing tablets will not be included.
- People with reduced kidney function (based on a blood test) may not be included, unless the studydoctor believes it is still safe.
- People with heart rhythm issues (such as prolonged QT interval [QT interval = time taken for the heart tobeat and prepare for the next beat.]) or conditions that may increase the risk of serious irregular heartbeatwill not be included.
- People with a family history of certain heart rhythm disorders (like Long QT Syndrome = Long QTSyndrome = a condition where the heart takes too long to reset between beats) may not be included.
- People who cannot stop taking medications (including herbal or over-the-counter medicines) before andduring the study will not be included. Some simple medications like paracetamol or vitamins may beallowed if the doctor approves.
- People with a history of stroke, seizures, or serious brain-related conditions will not be included.
- People with significant medical conditions affecting organs such as the heart, lungs, kidneys, liver,digestive system, immune system, or blood will not be included. In some cases, minor past conditions (likekidney stones or childhood asthma) may still be allowed if the doctor agrees.
- People with a history of cancer will not be included, except for certain minor skin cancers or cervicalconditions that were successfully treated many years ago.
- People with liver disease or abnormal liver test results may not be included, unless repeat tests areacceptable and approved by the doctor.
- People who have infections such as HIV, hepatitis B, or hepatitis C will not be included.

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)
Each participant will be given a unique randomization number at the time of assignment. This number will be used to identify them for all study procedures after randomization and will also be linked to their screening number. A participant can receive only one randomization number.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be allocated to treatment groups based on a computer-generated randomization schedule—receiving a specific treatment sequence in Cohort 1, and either SCY-770 or placebo in Cohorts 2and 3.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/07/2026
Actual
7/07/2026
Date of last participant enrolment
Anticipated
13/08/2026
Actual
Date of last data collection
Anticipated
2/09/2026
Actual
Sample size
Target
16
Accrual to date
8
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 322059 0
Commercial sector/Industry
Name [1] 322059 0
SCYNEXIS, Inc.
Country [1] 322059 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
SCYNEXIS, Inc.
Address
Country
Australia
Secondary sponsor category [1] 324938 0
Commercial sector/Industry
Name [1] 324938 0
Novotech (Australia) Pty Limited
Address [1] 324938 0
Country [1] 324938 0
India

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320587 0
Bellberry Human Research Ethics Committee A
Ethics committee address [1] 320587 0
Ethics committee country [1] 320587 0
Australia
Date submitted for ethics approval [1] 320587 0
06/05/2026
Approval date [1] 320587 0
04/06/2026
Ethics approval number [1] 320587 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 150982 0
Dr Christopher Argent
Address 150982 0
Scientia Clinical Research, Bright Building, Level 5, Corner High & Avoca Street, Randwick NSW 2031, Australia
Country 150982 0
Australia
Phone 150982 0
+61 0458639115
Fax 150982 0
Email 150982 0
[email protected]
Contact person for public queries
Name 150983 0
Misha Binder
Address 150983 0
Scynexis Inc., 1 Evertrust Plaza, Jersey City, NJ 07302
Country 150983 0
United States of America
Phone 150983 0
+1 732 766 0074
Fax 150983 0
Email 150983 0
[email protected]
Contact person for scientific queries
Name 150984 0
Christopher Argent
Address 150984 0
Scientia Clinical Research, Bright Building, Level 5, Corner High & Avoca Street, Randwick NSW 2031, Australia
Country 150984 0
Australia
Phone 150984 0
+61 0458639115
Fax 150984 0
Email 150984 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.